{"count":4801,"next":"http://api.gregory-ms.com/trials/?page=74","previous":"http://api.gregory-ms.com/trials/?page=72","results":[{"trial_id":3598,"title":"Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS","summary":null,"published_date":"2008-12-22T00:00:00Z","discovery_date":"2023-12-06T18:18:20.834713Z","link":"https://clinicaltrials.gov/show/NCT00813969","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT00813969"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"5411757","last_refreshed_on":"2016-04-11","scientific_title":"A Phase I Study to Assess the Feasibility, Safety, and Tolerability of Autologous Mesenchymal Stem Cell Transplantation in Patients With Relapsing Forms of Multiple Sclerosis","primary_sponsor":"The Cleveland Clinic","retrospective_flag":"Yes","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Not recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"55 Years","inclusion_gender":"Both","date_enrollement":"2011-03-28","target_size":"24","study_type":"Interventional","study_design":"Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment","phase":"Phase 1","countries":"United States","contact_firstname":"","contact_lastname":"Jeffrey A Cohen, M.D.","contact_address":null,"contact_email":null,"contact_tel":null,"contact_affiliation":"The Cleveland Clinic","inclusion_criteria":"
Inclusion Criteria:\r
\r
- Age 18 to 55, inclusive.\r
\r
- Diagnosis of MS\r
\r
- Relapsing form of MS (relapsing-remitting, secondary progressive, or\r
progressive-relapsing course).\r
\r
- EDSS score 3.0-6.5, inclusive. (Must be able to walk)\r
\r
- Active disease during prior 24 months.\r
\r
- Documented evidence of involvement of the anterior afferent visual system: previous\r
optic neuritis, optic atrophy or an afferent pupillary defect on exam, RNFL thickness\r
on OCT \r
- Cranial MRI scan demonstrating T2-hyperintense lesions satisfying diagnostic criteria\r
for MS\r
\r
- Ability to perform the component tests of the MSFC (T25FW, 9HPT, PASAT3).\r
\r
- Ability to perform SLCLA.\r
\r
- Has given written informed consent to participate in the study.\r
\r
Exclusion Criteria:\r
\r
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia,\r
septicemia) within 30 days of the Screening Visit.\r
\r
- History of cancer other than basal cell carcinoma of the skin.\r
\r
- History or laboratory results indicative of any significant cardiac, endocrine,\r
hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary,\r
gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder\r
that in the opinion of the Principal Investigator would preclude the safe performance\r
of BM aspiration, infusion of autologous MSCs, or performance of any of the planned\r
study assessments.\r
\r
- Abnormal blood tests which exceed designated limits.\r
\r
- Positive screening tests for hepatitis B, hepatitis C, HIV 1&2, HTLV I/II, CMV, West\r
Nile virus, syphilis, blood parasite infection.\r
\r
- Clinically significant abnormality on chest X-ray.\r
\r
- Clinically significant abnormality on EKG.\r
\r
- Oxygen-saturation <90% on room air.\r
\r
- History of alcohol or drug abuse within one year.\r
\r
- Any metallic material or electronic device in the body, or condition that precludes\r
the participant from undergoing MRI with Gd administration.\r
\r
- Uncontrolled glaucoma or other ocular condition that precludes performing OCT or\r
interpreting the results.\r
\r
- MS relapse with onset within 30 days prior to the Screening Visit or the participant\r
has not stabilized from a previous relapse at the time of the Screening Visit.\r
\r
- Current treatment with an investigational MS disease therapy.\r
\r
- Prior treatment with:\r
\r
Total lymphoid irradiation. Cladribine. T-cell or T-cell receptor vaccination. Campath-1h\r
(alemtuzumab). Rituxan (rituximab).\r
\r
- Prior treatment within three months with:\r
\r
Tysabri (natalizumab). Gilenya (Fingolimod/FTY720). Zenapax (daclizumab). Cytoxan\r
(cyclophosphamide). Novantrone (mitoxantrone). Cyclosporine. CellCept (mycophenolate\r
mofetil). Imuran (azathioprine). Rheumatrex (methotrexate). IV gamma globulin. Plasma\r
exchange.\r
\r
- Prior treatment within one month:\r
\r
Systemic corticosteroids with daily dose equivalent to Prednisone 60 mg or greater.\r
\r
- Female participants who are not post-menopausal for at least one year, not surgically\r
sterile, or not willing to practice effective contraception.\r
\r
- Nursing mothers, pregnant women, or women planning to become pregnant during the\r
study.\r
\r
- Male participants who are not willing to practice effective contraception.\r
\r
- Unwillingness or inability to comply with the requirements of this protocol including\r
the presence of any condition (physical, mental, or social) that, in the opinion of\r
the Principal Investigator, is likely to affect the participant's ability to comply\r
with the study protocol.\r
\r
- Any other reason that, in the opinion of the Principal Investigator, makes the\r
participant unsuitable for participation in the study.\r
","exclusion_criteria":null,"condition":"Relapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Progressive Relapsing Multiple Sclerosis","intervention":"Biological: Autologous mesenchymal stem cell transplantation","primary_outcome":"To evaluate the feasibility of culturing MSCs, and infusion-related safety and tolerability of autologous MSC transplantation over one month in patients with relapsing forms of MS","secondary_outcome":"To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions;To evaluate safety and tolerability of autologous MSC transplantation over 6 months","secondary_id":"MS-MSC-001","source_support":"Please refer to primary and secondary sponsors","ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3597,"title":"Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis","summary":null,"published_date":"2008-12-23T00:00:00Z","discovery_date":"2023-12-06T18:18:20.811840Z","link":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004753-14","source":"WHO XML import","relevant":null,"identifiers":{"euctr":"EUCTR2008-004753-14-BE"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"8819048","last_refreshed_on":"2020-02-01","scientific_title":"A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis - ENDORSE","primary_sponsor":"Biogen Idec Limited","retrospective_flag":"Yes","date_registration":null,"source_register":"EU Clinical Trials Register","recruitment_status":"Not Recruiting","other_records":"Yes","inclusion_agemin":null,"inclusion_agemax":null,"inclusion_gender":"
Female: yes
Male: yes
","date_enrollement":"2009-01-22","target_size":"1738","study_type":"Interventional clinical trial of medicinal product","study_design":"
Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
","phase":"Human pharmacology (Phase I): no\n Therapeutic exploratory (Phase II): no\n Therapeutic confirmatory - (Phase III): yes\n Therapeutic use (Phase IV): no","countries":"Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Guatemala;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand","contact_firstname":"Not Available","contact_lastname":null,"contact_address":"Innovation House, 70 Norden Road","contact_email":"clinicaltrials@biogen.com","contact_tel":null,"contact_affiliation":"Biogen Idec Limited","inclusion_criteria":"Inclusion criteria:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.\r
\r
2. Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 or 109MS302, including those subjects who received an open-label, approved MS therapy and completed the modified visit schedule.\r
\r
3. All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of BG00012.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1738
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
","exclusion_criteria":"Exclusion criteria:
1. Any significant change in medical history in subjects from 109MS301 or 109MS302, including laboratory tests, or current clinically significant condition that in the opinion of the Investigator would have excluded the subjects' participation from their previous study. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment.\r
\r
2. Subjects from 109MS301 or 109MS302 who discontinued BG00012 due to an AE or due to reasons other than protocol-defined relapse/disability progression.\r
\r
3. Subjects from 109MS301 or 109MS302 who discontinued study BG00012 due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.\r
\r
4. History of malignancy.\r
\r
5. History of severe allergic or anaphylactic reactions.\r
\r
6. Alanine transaminase (ALT), aspartate transaminase (AST), or\r
gamma-glutamyltransferase (GGT) >3 times the upper limit of normal (ULN).\r
\r
7. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.\r
\r
8. Previous participation in this study (109MS303).\r
\r
9. Unwillingness or inability to comply with the requirements of the\r
protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.\r
\r
10. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
","condition":"Relapsing-Remitting Multiple Sclerosis
\n MedDRA version: 20.0\n Level: PT\n Classification code 10063399\n Term: Relapsing-remitting multiple sclerosis\n System Organ Class: 10029205 - Nervous system disorders\n ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]","intervention":"
Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dimethyl Fumarate
CAS Number: 624497
Current Sponsor code: BG00012
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
","primary_outcome":"Main Objective: To evaluate the long-term safety profile of BG00012.;
Secondary Objective: To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (Expanded Disability Status Scale).
To evaluate further the long-term effects of BG00012 on MS brain lesions on MRI scans in subjects who had MRI scans as part of Studies 109MS301 and 109MS302 and in 109MS303 up through and including Amendment6. The following MRI endpoints will be evaluated in the subset of subjects who participated in the MRI scans: number and volume of Gd-enhancing lesions, number of new or newly enlarging T2 lesions and volume of total T2 lesions, number of new T1 hypointense lesions and volume of T1 hypointense lesions, brain atrophy, and magnetization transfer ratio (MTR).
To evaluate the long-term effects of BG00012 on health economics
assessments and the visual function test. The endpoints are the SF-36 and EQ-5D quality of life questionnaire, and the visual function test scores.
;Primary end point(s): The primary objective and endpoint is to evaluate the long-term safety profile of BG00012.;Timepoint(s) of evaluation of this end point: The safety analysis will focus on the 8-year safety data in the extension study. For subjects who were dosed with BG00012 in the previous study, long-term safety data (extension study + 2 years) may also be summarized.","secondary_outcome":"Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated for the 8 years in the extension phase and for some the extension study + 2 years starting from the original baseline of the Phase 3 studies (109MS301 and 109MS302).;
Secondary end point(s): • To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (EDSS).\r
\r
• To evaluate further the long-term effects of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (EDSS).\r
• To evaluatre further the long-term effects of BG00012 on MS brain lesions on MRI scans in subjects who had MRI scans as part of Studies 109MS301 and 109MS302 and in 109MS303 up through and including Amendment6. The following MRI endpoints will be evaluated in the subset of subjects who participated in the MRI scans: number and volume of Gd-enhancing lesions, number of new or newly enlarging T2 lesions and volume of total T2 lesions, number of new T1 hypointense lesions and volume of T1 hypointense lesions, brain atrophy, and MTR.\r
\r
• To evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. The endpoints are the SF-36 and EQ-5D quality of life questionnaire, and the visual function test scores.
","secondary_id":"109MS303;NCT00835770","source_support":"Biogen Idec Limited","ethics_review_status":"Approved","ethics_review_approval_date":"2009-01-22","ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3596,"title":"Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis","summary":null,"published_date":"2008-12-23T00:00:00Z","discovery_date":"2023-12-06T18:18:20.790625Z","link":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007459-28","source":"WHO XML import","relevant":null,"identifiers":{"euctr":"EUCTR2008-007459-28-DE"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"3023603","last_refreshed_on":"2012-11-19","scientific_title":"Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis","primary_sponsor":"Eli Lilly and Company","retrospective_flag":"Yes","date_registration":null,"source_register":"EU Clinical Trials Register","recruitment_status":"Not Recruiting","other_records":"Yes","inclusion_agemin":null,"inclusion_agemax":null,"inclusion_gender":"
Female: yes
Male: yes
","date_enrollement":"2009-08-10","target_size":"245","study_type":"Interventional clinical trial of medicinal product","study_design":"Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no","phase":null,"countries":"France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany","contact_firstname":null,"contact_lastname":null,"contact_address":null,"contact_email":null,"contact_tel":null,"contact_affiliation":null,"inclusion_criteria":"Inclusion criteria:
Inclusion Criteria
Subjects are eligible to be included in the study only if they meet all of the following
criteria:
[1] Qualify as having RRMS prior to Visit 2, based on the disease diagnostic criteria as defined by revised McDonald Criteria (Polman et al. 2005). (Search revised McDonald Criteria at http:// www.nationalmssociety.org).
[2] A Kurtzke EDSS (Kurtzke 1983) score of 0 through 5.0. This would include subjects who are ambulatory.
[3] Have at least 1 documented clinical relapse within 12 months prior to Visit 2; OR show evidence of Gd-enhancing lesion(s) of the brain or spine by MRI performed within 12 months prior to Visit 2.[4] Are 18 to 64 years of age, inclusive.
[5] Inclusion criterion [5] only applies to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause). These females must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate (<1% per year) during the study or for at least 8 weeks after the last injection of study drug, which ever is longer
(for example, use of oral contraceptives or Norplant®; a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
","exclusion_criteria":"Exclusion criteria:
•Have MS categorized as primary progressive, secondary progressive or progressive relapsing.
•Have had a relapse within 30 days and/or have not stabilized from a previous relapse and/or have had systemic corticosteroid therapy within 30 days prior to randomization.
•Have greater than 15 Gd-enhancing lesions of the brain by MRI performed between Visits 1 and 2.
•Have received any B cell biological therapies (such as rituximab, ocrelizumab, ofatumumab, belimumab, atacicept, or BR3-Fc); or have had treatment with cyclophosphamide, mitoxantrone, mycophenolate mofetil, or cladribine within the previous year; interferon beta or glatiramer acetate within 3 months prior to randomization; or cyclosporine, azathioprine, methotrexate, or intravenous immune globulin, plasmapheresis or cytapheresis within 6 months prior to randomization; or other biological agent/monoclonal antibody within 3 months prior to randomization; or a non-biologic drug or device that has not received regulatory approval for any indication within 30 days prior to the time of study entry.
•Have had a live vaccination within 3 months before randomization, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical trial within 3 months prior to randomization.
•Have had elective surgery within 2 weeks prior to randomization or are scheduled to have 1 during the study.
•Are immunocompromised; or have evidence of active infection (such as viral hepatitis and/or positive testing for tuberculosis or human immunodeficiency virus [HIV]); or have had a recent serious systemic infection. However, subjects with a history of active or latent TB who have documented evidence of adequate treatment may be enrolled in the study. Subjects who have had household contact with a person with active TB are excluded, unless appropriate and documented prophylaxis for TB was given..
•Have history of or current lymphoproliferative disease, malignant disease (except for resolved basal or squamous carcinoma); have significant allergies to humanized monoclonal antibodies or clinically significant or severe drug allergies/hypersensitivity; or have serious or unstable/uncontrolled illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic (other than MS), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator’s opinion, would place the subject at increased safety risk and/or could interfere with the analyses of safety and efficacy in this study.
•Have uncontrolled arterial hypertension characterized by a systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.
•Have known hypogammaglobulinemia or a serum IgG, IgM, or IgA concentration less than the lower limit of the reference range.
•Have hematology and/or serum chemistry laboratory test values outside the reference range for the population or investigative site that are considered clinically significant; and/or have specific abnormalities of white blood cells <3 G/L, lymphocytes <0.8 G.L, polymorphonuclear leukocytes <1.5 G/L, platelets <100 G/L, aspartate transaminase (AST) or alanine transaminase (ALT) >2 x upper limit of normal (ULN), bilirubin >1.5 x ULN, abnormal thyroid function, serum creatinine of >177 µmol/L, or a calculated creatinine clearance <60 mL/min.
•Have contraindications for MRI: pacemakers or other containdicated implanted metal devices, allergy to gadolinium, of","condition":"Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1\nLevel: LLT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis","intervention":"
Product Name: LY2127399
Product Code: LY2127399
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: N/a
CAS Number: N/a
Current Sponsor code: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-120
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
","primary_outcome":"Main Objective: Primary Objective
The primary objective of this study is to test the hypothesis that subjects with RRMS in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)-enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group.;Secondary Objective: To determine or evaluate:
Safety/tolerability of LY2127399 (LY) compared to placebo.
Whether Total:
number of Gd-enhancing MRI lesions,
number of new Gd-enhancing MRI lesions,
number of new or newly enlarging T2-weighted MRI lesions, and
volume of T2-weighted MRI lesions are statistically significantly less in =1 LY group compared to placebo over the 48-week duration of the study.
Whether the time to first relapse is statistically significantly longer in 1 or more LY groups compared to placebo.
Whether the proportion of relapse-free subjects is greater, and whether there is a
smaller annualized relapse rate over 24 and 48 weeks in =1 LY group compared to placebo.
Proportion of subjects with anti-LY antibodies at the end of the study.
PD of selected peripheral B cell subsets following administration of LY compared to placebo.
Serum PK of LY after multiple doses.
Effect of treatment with LY compared to placebo on EDSS, MSFC, VAS of Wellbeing, SF-36, and QIDS-SR16.
;Primary end point(s): is to test the hypothesis that subjects with relapsing remitting-multiple sclerosis (RRMS) in at least one LY2127399 group will have statistically significantly fewer cumulative total gadolinium (Gd)-enhancing MRI lesions over Weeks 12, 16, 20, and 24 compared to subjects in the placebo group.","secondary_outcome":null,"secondary_id":"H9B-MC-BCDJ(b)","source_support":null,"ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3595,"title":"Feasibility of abdominal massage for the alleviation of the symptoms of constipation in people with multiple sclerosis","summary":null,"published_date":"2009-05-01T00:00:00Z","discovery_date":"2023-12-06T18:18:20.758583Z","link":"http://isrctn.com/ISRCTN01328898","source":"WHO XML import","relevant":null,"identifiers":{"isrctn":"ISRCTN01328898"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"4534815","last_refreshed_on":"2015-01-13","scientific_title":"A randomised controlled pilot study to assess the feasibility of abdominal massage for the alleviation of the symptoms of constipation in people with multiple sclerosis","primary_sponsor":"Nursing Midwifery and Allied Health Professions Research Unit (UK)","retrospective_flag":"No","date_registration":null,"source_register":"ISRCTN","recruitment_status":"Not Recruiting","other_records":"No","inclusion_agemin":null,"inclusion_agemax":null,"inclusion_gender":"Both","date_enrollement":"2008-01-11","target_size":"30","study_type":"Interventional","study_design":"Pilot study, two-group randomised controlled clinical trial (Treatment)","phase":null,"countries":"United Kingdom","contact_firstname":null,"contact_lastname":null,"contact_address":null,"contact_email":null,"contact_tel":null,"contact_affiliation":null,"inclusion_criteria":"Inclusion criteria: 1. Constipation as defined by the Rome II criteria
2. Age range over 18 years, male or female","exclusion_criteria":"Exclusion criteria: 1. Bowel cancer
2. Stoma
3. Abdominal surgery (inside last year)","condition":"Multiple sclerosis
Nervous System Diseases
Multiple sclerosis","intervention":"Following expressing an interest in the study, potential participants will be provided with verbal and written information concerning their involvement and informed consent will be obtained. Providing screening is satisfactory, participants will then be randomly allocated to a treatment and a control group. Baseline outcome measures will be undertaken at this point by a research assistant who will be blind to group allocation:
1. Constipation Scoring System
2. Neurogenic Bowel Dysfunction Score
3. Bowel Diary
4. 29-item Multiple Sclerosis Impact Scale (MSIS-29)
5. Qualiveen Questionnaire
The intervention group will then be visited in their own home, provided with advice on good bowel habits and they and/or their carers will be shown how to undertake abdominal massage. This will be undertaken daily for 15 minutes for 4 weeks. A DVD demonstrating the technique will be left, and they will be visited at least once a week by the clinician to provide further training and support.
The control group will be visited in their own home and provided with advice on good bowel habits. This group will be visited once a week for 4 weeks.","primary_outcome":"Constipation scoring system, undertaken at the end of the intervention period (week 4) and 4 weeks later (week 8).","secondary_outcome":"1. Neurogenic Bowel Dysfunction Score
2. Bowel Diary
3. Qualiveen Questionnaire
4. 29-item Multiple Sclerosis Impact Scale (MSIS-29)
Outcome measures will be undertaken at the end of the intervention period (week 4) and 4 weeks later (week 8).","secondary_id":"08/NIR02/80","source_support":"Multiple Sclerosis Trust (UK)","ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3594,"title":"A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function","summary":null,"published_date":"2009-05-01T00:00:00Z","discovery_date":"2023-12-06T18:18:20.738403Z","link":"http://clinicaltrials.gov/show/NCT00818038","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT00818038"},"categories":[{"category_id":7,"category_description":"","category_name":"Natalizumab","category_slug":"natalizumab","category_terms":["natalizumab","tysabri"],"article_count":295}],"export_date":"2024-03-28T00:00:00Z","internal_number":"4652050","last_refreshed_on":"2015-02-19","scientific_title":"Phase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder Function","primary_sponsor":"Biogen Idec","retrospective_flag":"Yes","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Not recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"85 Years","inclusion_gender":"Both","date_enrollement":"2009-03-28","target_size":"30","study_type":"Observational","study_design":"Observational Model: Cohort, Time Perspective: Prospective","phase":"N/A","countries":"United States","contact_firstname":"","contact_lastname":"Medical Director","contact_address":null,"contact_email":null,"contact_tel":null,"contact_affiliation":"Biogen Idec","inclusion_criteria":"
Key Inclusion Criteria:\r
\r
Participants are eligible to be screened for this study if all of the following criteria\r
are met:\r
\r
- Patient must meet all prescribing criteria for TYSABRI® and eligible for the TOUCH™\r
program.\r
\r
- If utilizing medications for symptoms of bladder dysfunction (such as incontinence,\r
urgency etc), subjects will need to remain on a stable dose of medication(s) for at\r
least one month prior to and for duration of study.\r
\r
- If utilizing medications that affect urinary output (e.g. anticholinergics,\r
diuretics, etc.), subjects will need to remain on a stable dose of medication(s) for\r
at least one month prior to study entry and for the duration of the study.\r
\r
- Able to provide written informed consent.\r
\r
- Patient must be willing to maintain current hydration habits and caffeine intake for\r
the duration of the study.\r
\r
Participants will be selected for enrollment if all of the following criteria are met:\r
\r
- Screening Visit urinary incontinence defined as:\r
\r
- Greater than or equal to 3 incontinence episodes per week or greater than or equal\r
to 8 micturitions per day (both mean numbers).\r
\r
- Screening Visit score on the UDI-6 of more than or equal to 6.\r
\r
- Screening Visit EDSS 0 - 6.5\r
\r
Key Exclusion Criteria:\r
\r
Candidates will be excluded from study screening if any of the following exclusion\r
criteria exist:\r
\r
- Primary progressive, secondary progressive, or progressive relapsing MS. Primary\r
progressive, secondary progressive or progressive relapsing multiple sclerosis are\r
defined by Lublin and Reingold (Lublin and Reingold, 1996) or EDSS >6.5.\r
\r
- Current or previous history of Progressive Multifocal Leukencephalopathy (PML).\r
\r
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia,\r
septicemia) within 30 days.\r
\r
- History of recurrent or chronic urinary tract infection or a urinary tract infection\r
within the preceding 30 days prior to Week 0 (diagnosis based on clinical history and\r
Screening Visit urinalysis and urine culture).\r
\r
- Patients who have in-dwelling foley catheter or a suprapubic catheter.\r
\r
- Patients with a history of symptomatic benign prostatic hyperplasia (BPH) or a\r
history of prostate cancer.\r
\r
- History of, or abnormal laboratory results indicative of, any significant cardiac,\r
endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,\r
gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease, that,\r
in the opinion of the investigator, would preclude the administration of natalizumab\r
for the duration of the study.\r
\r
- Subject with history of malignancy within the past 2 years, with the exception of\r
basal cell carcinoma that has been treated.\r
\r
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.\r
\r
- Any prior treatment with the following medications: Natalizumab (TYSABRI®)\r
\r
- Nursing mothers, pregnant women, and women planning to become pregnant while in\r
study.\r
\r
- Any other reasons that, in the opinion of the Investigator and/or Sponsor, the\r
subject is determined to be unsuitable for enrollment into this study.\r
\r
- Unwillingness or inability to comply with the requirements of this protocol including\r
the presence of any condition (physical, mental, or social) that is likely to affect\r
the subject's ability to comply with the study protocol.\r
\r
- History of alcohol or drug abuse within 2 years prior to randomization.\r
\r
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile,\r
or willing to use a medically acceptable method of birth control during the study.\r
The rhythm method is not to be used as the sole method of contraception.\r
\r
Participants will be determined as screen failures if any of the following criteria apply:\r
\r
- Abnormal blood tests, performed at the screening visit, which exceed any of the\r
limits defined below:\r
\r
1. ALT/ SGPT, or AST/ SGOT more than three times the upper limit of normal (i.e.,\r
3xULN).\r
\r
2. Total white blood cell (WBC) count less than 2,300/mm3.\r
\r
3. Platelet count less than 100,000/mm3.\r
\r
4. Creatinine more than 2xULN.\r
\r
- Screening Visit urinary incontinence defined as less than 3 incontinence episodes per\r
week or less than 8 micturitions per day (both mean numbers).\r
\r
- Screening Visit score on the UDI-6 of less than 6.\r
\r
- Screening Visit EDSS more than 6.5.\r
\r
NOTE: Other protocol defined inclusion/exclusion criteria may apply.\r
","exclusion_criteria":null,"condition":"Relapsing-Remitting Multiple Sclerosis","intervention":"Drug: BG0002 (natalizumab)","primary_outcome":"Change in bladder function as measured by UDI-6 compared to baseline over 6 months of TYSABRI treatment.","secondary_outcome":"Change from baseline over 6 months of TYSABRI treatment in the number of urinary incontinence episodes per participant per week.;Change from baseline over 6 months of TYSABRI treatment in the number of micturitions per participant per day.;Change in NARCOMS PSB scores from baseline over 6 months of TYSABRI treatment.;Change in IIQ-7 scores from baseline over 6 months of TYSABRI treatment.","secondary_id":"US 006-08-NAT","source_support":"Please refer to primary and secondary sponsors","ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3593,"title":"Therapy Optimization in Multiple Sclerosis (MS)","summary":null,"published_date":"2009-07-01T00:00:00Z","discovery_date":"2023-12-06T18:18:20.718692Z","link":"http://clinicaltrials.gov/show/NCT00819000","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT00819000"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"4652123","last_refreshed_on":"2015-02-19","scientific_title":"TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty Pharmacies","primary_sponsor":"Teva Neuroscience, Inc.","retrospective_flag":"No","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Not recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"N/A","inclusion_gender":"Both","date_enrollement":"2008-12-28","target_size":"2878","study_type":"Observational","study_design":"Observational Model: Cohort, Time Perspective: Prospective","phase":"N/A","countries":"United States","contact_firstname":";","contact_lastname":"MerriKay Oleen-Burkey, PhD;Howard Zwibel, MD","contact_address":null,"contact_email":";","contact_tel":";","contact_affiliation":"Teva Neuroscience, Inc.;Neurologic Center of South Florida","inclusion_criteria":"
Inclusion Criteria:\r
\r
- Male or female, 18 years of age or older, with a diagnosis of MS.\r
\r
- Being treated with Glatiramer Acetate (GA) or (IFN)-ß\r
\r
- Receiving therapy from a participating Specialty Pharmacy\r
\r
Exclusion Criteria:\r
\r
- Has any contraindication to GA or IFN-ß therapy, including pregnancy, trying to\r
become pregnant, or breast feeding during the study\r
\r
- Has received an experimental drug in the last thirty (30) days other than Fampridine\r
SR (4-aminopyridine or 4-AP)\r
\r
- Unlikely to be able to participate for the full two years of the study\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis","intervention":"Drug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b","primary_outcome":"Relationship of therapy Medication Possession Ratio (MPR), to patient outcomes","secondary_outcome":"Relationship of therapy adherence, defined as the accumulation of time from initiation to discontinuation of therapy and measured by time, to patient outcomes","secondary_id":"PM032","source_support":"Please refer to primary and secondary sponsors","ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3592,"title":"A pilot single-centre randomised controlled trial of recombinant human erythropoietin versus placebo in primary progressive multiple sclerosis.","summary":null,"published_date":"2009-07-01T00:00:00Z","discovery_date":"2023-12-06T18:18:20.698117Z","link":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005125-11","source":"WHO XML import","relevant":null,"identifiers":{"euctr":"EUCTR2008-005125-11-GB"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"2472259","last_refreshed_on":"2012-03-19","scientific_title":"A pilot single-centre randomised controlled trial of recombinant human erythropoietin versus placebo in primary progressive multiple sclerosis.","primary_sponsor":"Walton Centre for Neurology and Neurosurgery","retrospective_flag":"No","date_registration":null,"source_register":"EU Clinical Trials Register","recruitment_status":"Not Recruiting","other_records":"No","inclusion_agemin":null,"inclusion_agemax":null,"inclusion_gender":"
Female: yes
Male: yes
","date_enrollement":"2008-12-19","target_size":null,"study_type":"Interventional clinical trial of medicinal product","study_design":"Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no","phase":null,"countries":"United Kingdom","contact_firstname":null,"contact_lastname":null,"contact_address":null,"contact_email":null,"contact_tel":null,"contact_affiliation":null,"inclusion_criteria":"Inclusion criteria:
Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001)With a primary progressive disease course.
18 to 65 years of age
EDSS 3 – 6.5
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
","exclusion_criteria":"Exclusion criteria:
Patients who are smokers. Ex-smokers will be required to have stopped smoking for at least 1 month.
Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
Patients taking sex steroid hormones.
Patients taking iron supplements.
Patients previously treated with rhEPO who developed a pure red cell aplasia.
Patients taking ACE inhibitors or Angiotensin II receptor antagonists.
Patients with uncontrolled hypertension. Patients with uncontrolled hypertension, or a screening blood pressure greater than 140/90 for two consecutive weeks.
Patients unable to receive thromboprophylaxis.
Pregnant or lactating women at the screening visit.
Abnormal screening blood tests exceeding any of the limits defined below:
\tPlatelets < 80 X109/L
\t\tBaseline neutrophil counts of less than 1.5 X109/L
\tTotal white blood cell count less than 2.3 X109/L
\tCreatinine 60 – 110 µmol/L
\t
Female patients, unless postmenopausal (2 years or more) or surgically sterile, who are unwilling to practice effective contraception during the study. The rhythm method is not to be used as the sole method of contraception.
Male patients and their partners who are unwilling to practice effective contraception during the study.
Women considering becoming pregnant while on study.
","condition":"Primary progressive multiple sclerosis
MedDRA version: 9.1\nLevel: LLT\nClassification code 10063401\nTerm: Primary progressive multiple sclerosis","intervention":"
Trade Name: Neorecormon
Product Name: Recombinant Human Erythropoietin
Product Code: rhEPO
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: epoetin beta
CAS Number: 122312-54-3
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 30000-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
","primary_outcome":"Main Objective: To assess the size of the effect, if any, of recombinant human erythropoietin (rhEPO) in improving symptoms of primary progressive multiple sclerosis (PPMS), as measured by Maximum Walking Distance, Multiple Sclerosis Functional Composite (MSFC), Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale 29 (MSIS), and Neurological Fatigue Index (NFI).;Secondary Objective: Provide data to allow sample size calculations for a larger multi-centre study for the primary outcome MSFC
Identify any barriers to patient recruitment
Provide information about withdrawals and loss to follow up in this population
Determine suitability of timing of follow up appointments and methods used to collect questionnaires (MSIS, NFI).
;Primary end point(s): Change in Maximum walking distance from baseline to last visit.
Change in EDSS from baseline to last visit.
","secondary_outcome":null,"secondary_id":"RCT-EPO-001","source_support":null,"ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3591,"title":"AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,\nrandomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis.","summary":null,"published_date":"2007-10-08T00:00:00Z","discovery_date":"2023-12-06T18:18:20.672442Z","link":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001031-63","source":"WHO XML import","relevant":null,"identifiers":{"euctr":"EUCTR2007-001031-63-CZ"},"categories":[{"category_id":18,"category_description":"Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs","category_name":"Physical therapy and Telerehabilitation","category_slug":"physical-therapy-and-telerehabilitation","category_terms":["telerehabilitation","physical therapy","virtual reality","gamification","neurostimulation","cognitive training","spasticity","motor control"],"article_count":174}],"export_date":"2024-03-28T00:00:00Z","internal_number":"5916138","last_refreshed_on":"2016-12-12","scientific_title":"AV650-018: A two-part (double-blind followed by open-label), placebo-controlled,\nrandomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects with spasticity associated with multiple sclerosis.","primary_sponsor":"Avigen Inc","retrospective_flag":"Yes","date_registration":null,"source_register":"EU Clinical Trials Register","recruitment_status":"Not Recruiting","other_records":"No","inclusion_agemin":null,"inclusion_agemax":null,"inclusion_gender":"
Female: yes
Male: yes
","date_enrollement":"2007-09-20","target_size":"150","study_type":"Interventional clinical trial of medicinal product","study_design":"Controlled: yes\nRandomised: yes\nOpen: yes\nSingle blind: no\nDouble blind: yes\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no","phase":"Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): no","countries":"Czech Republic;Germany","contact_firstname":null,"contact_lastname":null,"contact_address":null,"contact_email":null,"contact_tel":null,"contact_affiliation":null,"inclusion_criteria":"Inclusion criteria:
1. Male or female subjects between 18 and 70 years of age (inclusive)
2. Signed and dated informed consent
3. Definite MS as per Poser or MacDonald Criteria (either relapsing remitting or secondary progressive course)
4. Expanded Disability Status Score (EDSS) from 3.0 to 6.5 (inclusive) at Screening
5. Stable MS for at least 30 days before screening
6. Female of child bearing potential and male subjects whose partner is of child bearing potential who are willing to ensure that they or their partner use effective double-barrier contraception during the study and for 90 days thereafter
7. If female, be neither pregnant nor nursing (Confirmation that the subject is not pregnant must be established by a negative serum hCG pregnancy test at baseline.)
8. Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group
9. If a subject is on anti-spastic treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening
10. If a subject is on MS treatments, the dosage, frequency, and route of administration must be stable for at least 30 days before Screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
","exclusion_criteria":"Exclusion criteria:
1. Subjects who have participated in another research study within 90 days of Screening
2. Significant changes in anti-spasticity medications (dosage, frequency, or route of administration) within 30 days of Screening
3. Known hypersensitivity to tolperisone HCl, its components, or other lidocaine/lidocaine-like products
4. Use of tolperisone within 30 days of Screening
5. Significant changes in MS treatments (dosage, frequency, or route of administration) within 30 days of Screening
6. Spasticity due to neurological disorders other than MS
7. Any psychiatric disorder or cognitive impairment that precludes fully informed consent or safe participation in the study
8. Subjects who have suffered an acute relapse of MS or who continue to suffer from an acute relapse of MS within 90 days of Baseline
9. History of alcohol or substance abuse within one year of Screening
10. Concurrent clinically significant immunologic, pulmonary, renal, hepatic, or endocrine disease and/or other unstable or major disease other than MS
11. Clinically significant cardiovascular disorders, such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or acute myocardial infarction
12. QT prolongation greater than 480 msec or greater than 450 msec if accompanied by a partial bundle branch block, or other ECG abnormality in the judgment of the Investigator
13. Diastolic blood pressure <50mmHg or >105mmHg; heart rate <50 beats per minute (bpm) or >110bpm, after 3 minutes in a sitting position; heart rate by ECG <50bpm or >110bpm
14. History of epilepsy (except childhood febrile seizures)
15. Current malignancy or history of malignancy that has not been in remission for more than five years, except basal cell skin carcinoma and cervical cancer (with documentation of normal pap smears after definitive treatment)
16. Female subject who is pregnant, nursing, or planning pregnancy during the course of the study
17. Scheduled elective surgery or other procedures requiring general anesthesia during the study
18. Subject who is terminally ill in the judgment of the Investigator
19. Subject who is inappropriate for placebo medication in the judgment of the Investigator
20. Systemic corticosteroid therapy within 28 days of randomization, with the exception of inhaled medications for asthma
21. Exacerbation of MS within 30 days of Baseline.
22. Regular levo-dopa therapy within 7 days of randomization
23. Subjects taking antiarrhythmic medications
24. Donation of blood during the study
","condition":"Spasticity associated with multiple sclerosis
MedDRA version: 9.1\nLevel: LLT\nClassification code 10028335\nTerm: Muscle spasticity","intervention":"
Trade Name: Tolposan
Product Code: AV605
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tolperisone HC1
CAS Number: 728-88-1
Other descriptive name: Tolpersan
Concentration unit: mg milligram(s)
Concentration type: range
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
","primary_outcome":"Main Objective: To determine the long-term safety and tolerability of AV650 in subjects with spasticity associated with MS.;Secondary Objective: To determine preliminary efficacy of AV650 as compared to placebo in subjects with spasticity associated with MS.
To determine the pharmacokinetic (PK) profile of AV650 administered 150 mg TID or 300mg TID in subjects with
spasticity associated with MS.;Primary end point(s):","secondary_outcome":null,"secondary_id":"AV650-018","source_support":null,"ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3590,"title":"Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects","summary":null,"published_date":"2009-01-20T00:00:00Z","discovery_date":"2023-12-06T18:18:20.650547Z","link":"https://clinicaltrials.gov/show/NCT00828204","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT00828204"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"6492701","last_refreshed_on":"2017-10-19","scientific_title":"An Open-Label, Multicenter Study to Evaluate the Safe and Effective Use of the Single-Use Autoinjector With an Avonex® Prefilled Syringe in Multiple Sclerosis Subjects","primary_sponsor":"Biogen","retrospective_flag":"No","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Not recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"65 Years","inclusion_gender":"All","date_enrollement":"2009-01-28","target_size":"95","study_type":"Interventional","study_design":null,"phase":"Phase 3","countries":"United States;United States;United States;United States","contact_firstname":"; ; ;","contact_lastname":"Medical Director;Medical Director;Medical Director;Medical Director","contact_address":null,"contact_email":";;;","contact_tel":";;;","contact_affiliation":"Biogen;Biogen;Biogen;Biogen","inclusion_criteria":"
Inclusion Criteria:\r
\r
1. Ability to understand the purpose and risks of the study and provide signed and dated\r
informed consent and authorization to use protected health information (PHI) in\r
accordance with national and local subject privacy regulations.\r
\r
2. Must be 18 to 65 years old, inclusive, at the time of informed consent.\r
\r
3. Must currently be self-administering Avonex Prefilled Syringes to treat MS and must\r
have been self-administering Avonex Prefilled Syringes for the 12 weeks prior to the\r
Screening Visit.\r
\r
4. In the investigator's opinion, subjects must be willing and able to self-administer\r
all injections required by the protocol.\r
\r
5. Must speak English.\r
\r
6. All male subjects and female subjects of child-bearing potential must practice\r
effective contraception during the study.\r
\r
Exclusion Criteria:\r
\r
1. History of seizure disorder or unexplained blackouts OR history of a seizure within 3\r
months prior to the Screening Visit.\r
\r
2. History of suicidal ideation within 3 months prior to Day 1 or an episode of severe\r
depression within 3 months prior to Day 1. Severe depression is defined as any episode\r
of depression that requires hospitalization, or the initiation of antidepressant\r
therapy, or an increase in the dose of an existing regimen of antidepressant therapy.\r
NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the\r
study unless the dose has been increased within the 3 months prior to the Screening\r
Visit.\r
\r
3. Clinically significant local infection (for example cellulitis, abscess) or systemic\r
infection (pneumonia, septicemia), at the discretion of the Investigator.\r
\r
4. Known history of Human Immunodeficiency Virus (HIV).\r
\r
5. Known history of, or positive test result for hepatitis C virus (test for hepatitis C\r
virus antibody [HCV Ab]) or Hepatitis B virus (test for Hepatitis B Surface Antigen\r
[HBsAg] and/or Hepatitis B Core Antibody [HBcAb]).\r
;\r
Inclusion Criteria:\r
\r
1. Ability to understand the purpose and risks of the study and provide signed and dated\r
informed consent and authorization to use protected health information (PHI) in\r
accordance with national and local subject privacy regulations.\r
\r
2. Must be 18 to 65 years old, inclusive, at the time of informed consent.\r
\r
3. Must currently be self-administering Avonex Prefilled Syringes to treat MS and must\r
have been self-administering Avonex Prefilled Syringes for the 12 weeks prior to the\r
Screening Visit.\r
\r
4. In the investigator's opinion, subjects must be willing and able to self-administer\r
all injections required by the protocol.\r
\r
5. Must speak English.\r
\r
6. All male subjects and female subjects of child-bearing potential must practice\r
effective contraception during the study.\r
\r
Exclusion Criteria:\r
\r
1. History of seizure disorder or unexplained blackouts OR history of a seizure within 3\r
months prior to the Screening Visit.\r
\r
2. History of suicidal ideation within 3 months prior to Day 1 or an episode of severe\r
depression within 3 months prior to Day 1. Severe depression is defined as any episode\r
of depression that requires hospitalization, or the initiation of antidepressant\r
therapy, or an increase in the dose of an existing regimen of antidepressant therapy.\r
NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the\r
study unless the dose has been increased within the 3 months prior to the Screening\r
Visit.\r
\r
3. Clinically significant local infection (for example cellulitis, abscess) or systemic\r
infection (pneumonia, septicemia), at the discretion of the Investigator.\r
\r
4. Known history of Human Immunodeficiency Virus (HIV).\r
\r
5. Known history of, or positive test result for hepatitis C virus (test for hepatitis C\r
virus antibody [HCV Ab]) or Hepatitis B virus (test for Hepatitis B Surface Antigen\r
[HBsAg] and/or Hepatitis B Core Antibody [HBcAb]).\r
;\r
Inclusion Criteria:\r
\r
1. Ability to understand the purpose and risks of the study and provide signed and dated\r
informed consent and authorization to use protected health information (PHI) in\r
accordance with national and local subject privacy regulations.\r
\r
2. Must be 18 to 65 years old, inclusive, at the time of informed consent.\r
\r
3. Must currently be self-administering Avonex Prefilled Syringes to treat MS and must\r
have been self-administering Avonex Prefilled Syringes for the 12 weeks prior to the\r
Screening Visit.\r
\r
4. In the investigator's opinion, subjects must be willing and able to self-administer\r
all injections required by the protocol.\r
\r
5. Must speak English.\r
\r
6. All male subjects and female subjects of child-bearing potential must practice\r
effective contraception during the study.\r
\r
Exclusion Criteria:\r
\r
1. History of seizure disorder or unexplained blackouts OR history of a seizure within 3\r
months prior to the Screening Visit.\r
\r
2. History of suicidal ideation within 3 months prior to Day 1 or an episode of severe\r
depression within 3 months prior to Day 1. Severe depression is defined as any episode\r
of depression that requires hospitalization, or the initiation of antidepressant\r
therapy, or an increase in the dose of an existing regimen of antidepressant therapy.\r
NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the\r
study unless the dose has been increased within the 3 months prior to the Screening\r
Visit.\r
\r
3. Clinically significant local infection (for example cellulitis, abscess) or systemic\r
infection (pneumonia, septicemia), at the discretion of the Investigator.\r
\r
4. Known history of Human Immunodeficiency Virus (HIV).\r
\r
5. Known history of, or positive test result for hepatitis C virus (test for hepatitis C\r
virus antibody [HCV Ab]) or Hepatitis B virus (test for Hepatitis B Surface Antigen\r
[HBsAg] and/or Hepatitis B Core Antibody [HBcAb]).\r
;\r
Inclusion Criteria:\r
\r
1. Ability to understand the purpose and risks of the study and provide signed and dated\r
informed consent and authorization to use protected health information (PHI) in\r
accordance with national and local subject privacy regulations.\r
\r
2. Must be 18 to 65 years old, inclusive, at the time of informed consent.\r
\r
3. Must currently be self-administering Avonex Prefilled Syringes to treat MS and must\r
have been self-administering Avonex Prefilled Syringes for the 12 weeks prior to the\r
Screening Visit.\r
\r
4. In the investigator's opinion, subjects must be willing and able to self-administer\r
all injections required by the protocol.\r
\r
5. Must speak English.\r
\r
6. All male subjects and female subjects of child-bearing potential must practice\r
effective contraception during the study.\r
\r
Exclusion Criteria:\r
\r
1. History of seizure disorder or unexplained blackouts OR history of a seizure within 3\r
months prior to the Screening Visit.\r
\r
2. History of suicidal ideation within 3 months prior to Day 1 or an episode of severe\r
depression within 3 months prior to Day 1. Severe depression is defined as any episode\r
of depression that requires hospitalization, or the initiation of antidepressant\r
therapy, or an increase in the dose of an existing regimen of antidepressant therapy.\r
NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the\r
study unless the dose has been increased within the 3 months prior to the Screening\r
Visit.\r
\r
3. Clinically significant local infection (for example cellulitis, abscess) or systemic\r
infection (pneumonia, septicemia), at the discretion of the Investigator.\r
\r
4. Known history of Human Immunodeficiency Virus (HIV).\r
\r
5. Known history of, or positive test result for hepatitis C virus (test for hepatitis C\r
virus antibody [HCV Ab]) or Hepatitis B virus (test for Hepatitis B Surface Antigen\r
[HBsAg] and/or Hepatitis B Core Antibody [HBcAb]).\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis","intervention":"Device: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a);Device: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a);Device: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a);Device: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a)","primary_outcome":"Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector;Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector","secondary_outcome":null,"secondary_id":"108MS302","source_support":"Please refer to primary and secondary sponsors","ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null},{"trial_id":3589,"title":"Safety of Polyphenon E in Multiple Sclerosis Pilot Study","summary":null,"published_date":"2009-03-02T00:00:00Z","discovery_date":"2023-12-06T18:18:20.611004Z","link":"https://clinicaltrials.gov/show/NCT00836719","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT00836719"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"6492927","last_refreshed_on":"2017-10-19","scientific_title":"Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis","primary_sponsor":"Louisiana State University Health Sciences Center in New Orleans","retrospective_flag":"No","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Not recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"65 Years","inclusion_gender":"All","date_enrollement":"2009-02-28","target_size":"10","study_type":"Interventional","study_design":null,"phase":"Phase 1","countries":"United States;United States;United States;United States","contact_firstname":"; ; ;","contact_lastname":"Jesus F Lovera, MD, MSPH;Jesus F Lovera, MD, MSPH;Jesus F Lovera, MD, MSPH;Jesus F Lovera, MD, MSPH","contact_address":null,"contact_email":";;;","contact_tel":";;;","contact_affiliation":"LSUHSC;LSUHSC;LSUHSC;LSUHSC","inclusion_criteria":"
Inclusion Criteria:\r
\r
- Diagnosis of MS by McDonald criteria\r
\r
- Relapsing-remitting MS or secondary progressive MS\r
\r
- Stable therapy with Copaxone, for at least six months prior to inclusion in the study\r
or no therapy for six months in subjects refusing therapy.\r
\r
- EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)\r
\r
- Ages 18-60.\r
\r
- Leukocytes =3,000/µL\r
\r
- Absolute neutrophil count =1,500/µL\r
\r
- Platelets =100,000/µL\r
\r
- Total bilirubin =local upper limit of normal\r
\r
- normal AST (SGOT) ALT (SGPT)\r
\r
- normal serum Creatinine\r
\r
- women of child-bearing potential and men must agree to use adequate contraception\r
(hormonal or barrier method of birth control; abstinence) prior to study entry and for\r
the duration of study participation.\r
\r
- Ability to understand and the willingness to sign a written informed consent document.\r
\r
- Willing to drink at most one cup of black tea and two cups of coffee per day, and\r
abstain from drinking green tea or taking supplements containing green tea or green\r
tea compounds, for the duration of the investigation.\r
\r
Exclusion Criteria:\r
\r
- MS relapse within the 30 days prior to enrollment.\r
\r
- A primary progressive form of MS.\r
\r
- Previous treatment prior to study entry as follows: complete radiation ablation of the\r
bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,\r
cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or\r
immunosuppressant therapies except for Copaxone or methylprednisone for relapses\r
within prior nine months.\r
\r
- History of renal or liver disease.\r
\r
- Consumption of green tea or supplements containing green tea or tea extract within 30\r
days prior to enrollment.\r
\r
- Participants may not participate in any other clinical trial involving investigational\r
agents during the study, or within six months prior to enrolling in the study.\r
\r
- history of allergic reactions attributed to compounds of similar chemical or biologic\r
composition to Polyphenon E, tea, or any of the inactive ingredients present in the\r
active or placebo capsules, including gelatin.\r
\r
- history of allergic reactions to gadolinium or any other condition contraindicated for\r
MRI.\r
\r
- Uncontrolled, clinically-relevant active illness (aside from MS) including, but not\r
limited to, ongoing or active infection, symptomatic congestive heart failure,\r
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations\r
that would limit compliance with study requirements.\r
\r
- Any condition which would make the subject, in the opinion of the investigator,\r
unsuitable for the study.\r
\r
- Inability to complete the baseline MRI scan.\r
\r
- Pregnant or breastfeeding women.\r
;\r
Inclusion Criteria:\r
\r
- Diagnosis of MS by McDonald criteria\r
\r
- Relapsing-remitting MS or secondary progressive MS\r
\r
- Stable therapy with Copaxone, for at least six months prior to inclusion in the study\r
or no therapy for six months in subjects refusing therapy.\r
\r
- EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)\r
\r
- Ages 18-60.\r
\r
- Leukocytes =3,000/µL\r
\r
- Absolute neutrophil count =1,500/µL\r
\r
- Platelets =100,000/µL\r
\r
- Total bilirubin =local upper limit of normal\r
\r
- normal AST (SGOT) ALT (SGPT)\r
\r
- normal serum Creatinine\r
\r
- women of child-bearing potential and men must agree to use adequate contraception\r
(hormonal or barrier method of birth control; abstinence) prior to study entry and for\r
the duration of study participation.\r
\r
- Ability to understand and the willingness to sign a written informed consent document.\r
\r
- Willing to drink at most one cup of black tea and two cups of coffee per day, and\r
abstain from drinking green tea or taking supplements containing green tea or green\r
tea compounds, for the duration of the investigation.\r
\r
Exclusion Criteria:\r
\r
- MS relapse within the 30 days prior to enrollment.\r
\r
- A primary progressive form of MS.\r
\r
- Previous treatment prior to study entry as follows: complete radiation ablation of the\r
bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,\r
cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or\r
immunosuppressant therapies except for Copaxone or methylprednisone for relapses\r
within prior nine months.\r
\r
- History of renal or liver disease.\r
\r
- Consumption of green tea or supplements containing green tea or tea extract within 30\r
days prior to enrollment.\r
\r
- Participants may not participate in any other clinical trial involving investigational\r
agents during the study, or within six months prior to enrolling in the study.\r
\r
- history of allergic reactions attributed to compounds of similar chemical or biologic\r
composition to Polyphenon E, tea, or any of the inactive ingredients present in the\r
active or placebo capsules, including gelatin.\r
\r
- history of allergic reactions to gadolinium or any other condition contraindicated for\r
MRI.\r
\r
- Uncontrolled, clinically-relevant active illness (aside from MS) including, but not\r
limited to, ongoing or active infection, symptomatic congestive heart failure,\r
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations\r
that would limit compliance with study requirements.\r
\r
- Any condition which would make the subject, in the opinion of the investigator,\r
unsuitable for the study.\r
\r
- Inability to complete the baseline MRI scan.\r
\r
- Pregnant or breastfeeding women.\r
;\r
Inclusion Criteria:\r
\r
- Diagnosis of MS by McDonald criteria\r
\r
- Relapsing-remitting MS or secondary progressive MS\r
\r
- Stable therapy with Copaxone, for at least six months prior to inclusion in the study\r
or no therapy for six months in subjects refusing therapy.\r
\r
- EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)\r
\r
- Ages 18-60.\r
\r
- Leukocytes =3,000/µL\r
\r
- Absolute neutrophil count =1,500/µL\r
\r
- Platelets =100,000/µL\r
\r
- Total bilirubin =local upper limit of normal\r
\r
- normal AST (SGOT) ALT (SGPT)\r
\r
- normal serum Creatinine\r
\r
- women of child-bearing potential and men must agree to use adequate contraception\r
(hormonal or barrier method of birth control; abstinence) prior to study entry and for\r
the duration of study participation.\r
\r
- Ability to understand and the willingness to sign a written informed consent document.\r
\r
- Willing to drink at most one cup of black tea and two cups of coffee per day, and\r
abstain from drinking green tea or taking supplements containing green tea or green\r
tea compounds, for the duration of the investigation.\r
\r
Exclusion Criteria:\r
\r
- MS relapse within the 30 days prior to enrollment.\r
\r
- A primary progressive form of MS.\r
\r
- Previous treatment prior to study entry as follows: complete radiation ablation of the\r
bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,\r
cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or\r
immunosuppressant therapies except for Copaxone or methylprednisone for relapses\r
within prior nine months.\r
\r
- History of renal or liver disease.\r
\r
- Consumption of green tea or supplements containing green tea or tea extract within 30\r
days prior to enrollment.\r
\r
- Participants may not participate in any other clinical trial involving investigational\r
agents during the study, or within six months prior to enrolling in the study.\r
\r
- history of allergic reactions attributed to compounds of similar chemical or biologic\r
composition to Polyphenon E, tea, or any of the inactive ingredients present in the\r
active or placebo capsules, including gelatin.\r
\r
- history of allergic reactions to gadolinium or any other condition contraindicated for\r
MRI.\r
\r
- Uncontrolled, clinically-relevant active illness (aside from MS) including, but not\r
limited to, ongoing or active infection, symptomatic congestive heart failure,\r
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations\r
that would limit compliance with study requirements.\r
\r
- Any condition which would make the subject, in the opinion of the investigator,\r
unsuitable for the study.\r
\r
- Inability to complete the baseline MRI scan.\r
\r
- Pregnant or breastfeeding women.\r
;\r
Inclusion Criteria:\r
\r
- Diagnosis of MS by McDonald criteria\r
\r
- Relapsing-remitting MS or secondary progressive MS\r
\r
- Stable therapy with Copaxone, for at least six months prior to inclusion in the study\r
or no therapy for six months in subjects refusing therapy.\r
\r
- EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)\r
\r
- Ages 18-60.\r
\r
- Leukocytes =3,000/µL\r
\r
- Absolute neutrophil count =1,500/µL\r
\r
- Platelets =100,000/µL\r
\r
- Total bilirubin =local upper limit of normal\r
\r
- normal AST (SGOT) ALT (SGPT)\r
\r
- normal serum Creatinine\r
\r
- women of child-bearing potential and men must agree to use adequate contraception\r
(hormonal or barrier method of birth control; abstinence) prior to study entry and for\r
the duration of study participation.\r
\r
- Ability to understand and the willingness to sign a written informed consent document.\r
\r
- Willing to drink at most one cup of black tea and two cups of coffee per day, and\r
abstain from drinking green tea or taking supplements containing green tea or green\r
tea compounds, for the duration of the investigation.\r
\r
Exclusion Criteria:\r
\r
- MS relapse within the 30 days prior to enrollment.\r
\r
- A primary progressive form of MS.\r
\r
- Previous treatment prior to study entry as follows: complete radiation ablation of the\r
bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,\r
cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or\r
immunosuppressant therapies except for Copaxone or methylprednisone for relapses\r
within prior nine months.\r
\r
- History of renal or liver disease.\r
\r
- Consumption of green tea or supplements containing green tea or tea extract within 30\r
days prior to enrollment.\r
\r
- Participants may not participate in any other clinical trial involving investigational\r
agents during the study, or within six months prior to enrolling in the study.\r
\r
- history of allergic reactions attributed to compounds of similar chemical or biologic\r
composition to Polyphenon E, tea, or any of the inactive ingredients present in the\r
active or placebo capsules, including gelatin.\r
\r
- history of allergic reactions to gadolinium or any other condition contraindicated for\r
MRI.\r
\r
- Uncontrolled, clinically-relevant active illness (aside from MS) including, but not\r
limited to, ongoing or active infection, symptomatic congestive heart failure,\r
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations\r
that would limit compliance with study requirements.\r
\r
- Any condition which would make the subject, in the opinion of the investigator,\r
unsuitable for the study.\r
\r
- Inability to complete the baseline MRI scan.\r
\r
- Pregnant or breastfeeding women.\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis","intervention":"Drug: Polyphenon E;Drug: Polyphenon E;Drug: Polyphenon E;Drug: Polyphenon E","primary_outcome":"Number of Participants Experiencing Serious Adverse Events;Number of Participants Experiencing Serious Adverse Events","secondary_outcome":"Change in Brain NAA Level as Measured by MR Spectroscopy","secondary_id":"K23AT004433-01;1K23AT004433-01;K23AT004433-01","source_support":"Please refer to primary and secondary sponsors","ethics_review_status":null,"ethics_review_approval_date":null,"ethics_review_contact_name":null,"ethics_review_contact_address":null,"ethics_review_contact_phone":null,"ethics_review_contact_email":null,"results_date_completed":null,"results_url_link":null}]}