Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=79
{ "count": 4866, "next": "http://api.gregory-ms.com/trials/?format=api&page=80", "previous": "http://api.gregory-ms.com/trials/?format=api&page=78", "results": [ { "trial_id": 3603, "title": "A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis", "summary": null, "published_date": "2008-12-12T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.942756Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005304-93", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-005304-93-GB" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "2469555", "last_refreshed_on": "2012-03-19", "scientific_title": "A Randomised Control Trial To Evaluate Whether Zoledronate Prevents Bone Loss In Acute Exacerbations Of Multiple Sclerosis - Zoledronate in multiple sclerosis", "primary_sponsor": "North Bristol Trust", "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": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2009-02-13", "target_size": null, "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: yes\nDouble blind: no\nParallel group: no\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: <br>Age 18-65 with established MS<br>Acute flare-up requiring treatment with a corticosteroid<br>Able to attend for study investigations and assessments<br>Willing and able to provide informed consent<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>Previous diagnosis of osteoporosis<br>Bone active therapy within previous 12 months (excluding calcium and low dose vitamin D), previous treatment with bisphosphonate at any time.<br>Associated disorder which may influence bone metabolism<br>Moderate to severe renal impairment (creatinine>150)<br>Cardiac failure<br>Possibility of pregnancy<br>Breast feeding<br><br>", "condition": "Bone loss in patients with Multiple Sclerosis (MS) who require large short term doses of methylprednisolone for exacerbations of their disease. <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10048393\nTerm: Multiple sclerosis relapse\n <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10065687\nTerm: Bone loss", "intervention": "<br>Trade Name: Aclasta 5mg solution for infusion<br>Product Name: Aclasta<br>Product Code: ZOL446H<br>Pharmaceutical Form: Solution for infusion<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br>", "primary_outcome": "Main Objective: Patients with MS who are experiencing an exacerbation of their disease symptoms are traditionally treated with either a 3 day course of intravenous high dose corticosteroids (methylprednisolone) or sometimes a 5 day course of oral corticosteroids (methylprednisolone).The principal objective is to discover whether giving a single intravenous infusion of a bisphosphonate, zoledronate, immediately prior to the corticosteroid therapy will prevent the bone thinning effect of the steroid and the associated increase in fracture risk.<br>;Secondary Objective: The secondary objective is to discover whether those patients given zoledronate had a prolonged period of protection for their bones, therefore reducing their risk of fracture.;Primary end point(s): The hypothesis is that a single zoledronate infusion prior to a course of corticosteroid will prevent the rapid increase in bone resorption which normally occurs in response to high dose steroid therapy. The primary outcome will be a significant difference in serum CTX according to treatment group at day 7 the study.", "secondary_outcome": null, "secondary_id": "ZOL40/02", "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": 3602, "title": "An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study", "summary": null, "published_date": "2008-12-12T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.921298Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005021-11", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-005021-11-BE" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "2633340", "last_refreshed_on": "2012-06-12", "scientific_title": "An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study", "primary_sponsor": "Merck Serono SA - Geneva, An affiliate of Merck KGaA, Darmstadt, Germany", "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": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2009-10-14", "target_size": "68", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: no\nRandomised: \nOpen: \nSingle blind: \nDouble blind: \nParallel group: \nCross over: \nOther: \nIf controlled, specify comparator, Other Medicinial Product: \nPlacebo: \nOther:", "phase": null, "countries": "Czech Republic;Belgium;France;Sweden", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>Inclusion Criteria for Participation in Study 28851:<br>- Participation in study 28063.<br>- Completion of Week 36 visit of the core study 28063<br>- Willingness and ability to comply with study procedures for the duration of the study.<br>- Voluntary provision of written informed consent (including, for the USA, subject<br>authorization under the Health Insurance Portability and Accountability Act (HIPAA)),<br>given before any study-related procedure that is not part of normal medical care and<br>with the understanding that the subject may withdraw consent at any time without<br>prejudice to his or her future medical care.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>Exclusion Criteria for Participation in Study 28851:<br>- Premature discontinuation of core study 28063.<br>", "condition": "Relapsing multiple sclerosis <br>MedDRA version: 9.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Name: atacicept<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: atacicept<br>Other descriptive name: TACI-Fc5<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 25-<br><br>Product Name: atacicept<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: atacicept<br>Other descriptive name: TACI-Fc5<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 75-<br><br>Product Name: atacicept<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: atacicept<br>Other descriptive name: TACI-Fc5<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 150-<br><br>", "primary_outcome": "Main Objective: The main objective of the study is to monitor the long-term safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).;Secondary Objective: - To describe the long-term course of measures of MS disease activity and progression, such as relapse activity and EDSS, under atacicept treatment in subjects with RMS.<br>- To describe the long-term effects of atacicept treatment on inflammation and CNS tissue integrity as measured by magnetic resonance imaging (MRI). <br>- To study atacicept’s long-term biological activity by the assessment of pharmacodynamic (PD) and pharmacogenomic markers.<br>- To explore atacicept’s immunogenicity, in particular the potential late development and persistence of neutralizing antibodies.<br>;Primary end point(s): Parameters related to the main study objective:<br>- Nature and severity of adverse events (AEs) and serious AEs (SAEs), in particular infections and malignancies.<br>- Hematology and blood chemistry laboratory parameters.<br>- Injection site reactions.<br>- Vital signs, ECGs.<br>- IgG levels, in particular IgG level <3 g/L at any time during the study.<br>- Immunogenicity: development of NAb to atacicept, persistence of NAb in subjects who become NAb-positive either in the core study or in the extension study (if this occurs).<br><br>", "secondary_outcome": null, "secondary_id": "28851", "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": 3601, "title": "Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis", "summary": null, "published_date": "2008-12-16T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.900757Z", "link": "http://clinicaltrials.gov/show/NCT00819195", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00819195" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "4652138", "last_refreshed_on": "2015-02-19", "scientific_title": "Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis", "primary_sponsor": "University of California, San Francisco", "retrospective_flag": "No", "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": "2008-12-13", "target_size": "17", "study_type": "Observational", "study_design": "Observational Model: Cohort, Time Perspective: Prospective", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Scott S. Zamvil, M.D. Ph.D.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "UCSF Department of Neurology", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Relapsing-remitting (RR) MS patients (McDonald criteria)\r<br>\r<br> - Ages 18-55\r<br>\r<br> - Males and females\r<br>\r<br> - EDSS score =5\r<br>\r<br> - No prior treatment with Copaxone\r<br>\r<br> - Prior treatment with corticosteroids or interferon-beta (-1a or -1b) is acceptable,\r<br> provided there is a washout period of at least one month\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Treatment with Tysabri, Novantrone or cyclophosphamide\r<br>\r<br> - Treatment with other immunomodulatory therapies (e.g. imuran, mycophenolate or\r<br> methotrexate)\r<br>\r<br> - Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis\r<br>\r<br> - Pregnancy\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: Glatiramer acetate", "primary_outcome": "Production of inflammatory cytokines by monocytes and naive T cells.", "secondary_outcome": null, "secondary_id": "10-03877", "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": 3600, "title": "", "summary": null, "published_date": "2006-05-12T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.879806Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003696-12", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2006-003696-12-BE" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "2811189", "last_refreshed_on": "2012-10-09", "scientific_title": "A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/A", "primary_sponsor": "Biogen Idec Ltd.", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "Yes", "inclusion_agemin": "", "inclusion_agemax": "", "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2007-02-03", "target_size": "1011", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\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": null, "countries": "Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Italy;Greece;Austria;Sweden", "contact_firstname": "", "contact_lastname": "", "contact_address": "", "contact_email": "", "contact_tel": "", "contact_affiliation": "", "inclusion_criteria": "Inclusion criteria: <br>1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).<br>2. Aged 18 to 55 years old, inclusive, at the time of informed consent.<br>3. Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4<br>(Polman et al, 2005).<br>4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.<br>5. Must have experienced at least 1 relapse within the 12 months prior to randomization,with a prior brain MRI demonstrating lesion(s) consistent with MS or show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.<br>6. Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>Medical History<br>1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.<br>2. Unable to perform the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, and PASAT 3.<br>3. Unable to perform visual function tests.<br>4. History of malignancy, unless an exception is granted by the Biogen Idec Medical Director. (Subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).<br>5. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.<br>6. History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that would preclude participation in a clinical trial.<br>7. History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS) and/or other major disease that would preclude participation in a clinical trial.<br>8. History of human immunodeficiency virus (HIV).<br>9. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.<br>10. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.<br>11. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.<br>12. Any of the following abnormal blood tests at screening:<br>• alanine transaminase/serum glutamate-pyruvate transaminase (ALT/SGPT), or<br>aspartate transaminase/serum glutamic-oxaloacetic transaminase (AST/SGOT), or<br>gamma-glutamyl-transferase (GGT) =2 times the upper limit of normal (ULN)<br>• leukocytes <3500/mm3<br>• eosinophils >0.7 × 10³/µL or >0.7 GI/L.<br>13. Any of the following abnormal urine tests at screening confirmed by the second urinalysis 2 weeks later:<br>• proteinuria (1+ or greater)<br>• hematuria, without known etiology (e.g. urinary tract infection, menses)<br>• glycosuria, without known etiology (e.g. recent steroid use, elevated serum glucose)<br><br>Treatment History<br>14. Any previous treatment with FUMADERM® or BG00012 (FAG-201).<br>15. Prior treatment with any of the following:<br>• total lymphoid irradiation<br>• cladribine<br>• T-cell or T-cell receptor vaccination<br>• any therapeutic monoclonal antibody, with the exception of TYSABRI®<br>(natalizumab) (see exclusion #17)<br>16. Prior treatment with any of the following within 1 year prior to randomization:<br>• mitoxantrone<br>• cyclophosphamide<br>17. Prior treatment with any of the following medications or procedures within the 6 months<br>prior to randomization:<br>• cyclosporine<br>• azathioprine<br>• methotrexate<br>• natalizumab (TYSABRI®)<br>• mycophenolate mofetil<br>• intravenous immunoglobulin<br>• plasmapheresis or cytapheresis.<br>18. Prior treatment with any of the following within the 3 months prior to randomization:<br>• subcutaneous or oral glatiramer acetate<br>• interferon-alpha<br>• interferon-beta.<br>19. Treatment with any of the following medications within the 50 days prior to<br>randomization:<br>• steroids (intravenous [IV] or oral corticosteroid treatment, including agents that may act through t", "condition": "Relapsing-Remitting Multiple Sclerosis <br>MedDRA version: 8.1\nLevel: LLT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Name: BG00012<br>Pharmaceutical Form: Capsule, hard<br>CAS Number: 624497<br>Other descriptive name: DIMETHYL FUMARATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 120-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: The primary objective of this study is to determine whether BG00012, when compared with placebo, is effective in reducing the proportion of relapsing subjects at 2 years.<br>;Secondary Objective: To determine whether BG00012, when compared with placebo, is effective in:<br><br>- reducing the total number of new or newly enlarging T2 hyperintense lesions on brain MRI scans in a subset of subjects at 2 years;<br><br>- reducing the total number of Gd-enhancing lesions on 3 brain MRI scans taken at 2 years in a subset of subjects;<br><br>- reducing the rate of clinical relapses at 2 years;<br><br>- slowing the progression of disability at 2 years as measured by at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from the baseline EDSS is greater than or equal to 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks.;Primary end point(s): Proportion of subjects relapsed at 2 years", "secondary_outcome": null, "secondary_id": "109MS301;N/A", "source_support": "", "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": 3599, "title": "Regional Cortical Cerebral Quantitative MRI Perfusion Correlation Neurocognition in Multiple Sclerosis", "summary": null, "published_date": "2008-12-19T00:00:00Z", "discovery_date": "2023-12-06T18:18:20.855630Z", "link": "https://clinicaltrials.gov/show/NCT00812474", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00812474" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "5240987", "last_refreshed_on": "2015-12-07", "scientific_title": "Regional Cortical Cerebral Quantitative MRI Perfusion Correlation Neurocognition in Multiple Sclerosis", "primary_sponsor": "Sunnybrook Health Sciences Centre", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "16 Years", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2008-12-13", "target_size": "60", "study_type": "Observational", "study_design": "Observational Model: Case Control, Time Perspective: Prospective", "phase": "N/A", "countries": null, "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - established SPMS according to the McDonald criteria\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients with a history of drug/alcohol abuse, a premorbid (pre MS) psychiatric\r<br> history, a head injury with loss of consciousness and a concurrent physical disease\r<br> requiring medical attention (eg. cardiovascular disease etc), MRI contraindication\r<br> including implants, pacemaker, aneurysm clips and known renal impairment\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": null, "primary_outcome": "Cognitive Impairment", "secondary_outcome": null, "secondary_id": "373-2007", "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": 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": "2024-05-13T00:00:00Z", "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": "2011-03-13", "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": "<br> Inclusion Criteria:\r<br>\r<br> - Age 18 to 55, inclusive.\r<br>\r<br> - Diagnosis of MS\r<br>\r<br> - Relapsing form of MS (relapsing-remitting, secondary progressive, or\r<br> progressive-relapsing course).\r<br>\r<br> - EDSS score 3.0-6.5, inclusive. (Must be able to walk)\r<br>\r<br> - Active disease during prior 24 months.\r<br>\r<br> - Documented evidence of involvement of the anterior afferent visual system: previous\r<br> optic neuritis, optic atrophy or an afferent pupillary defect on exam, RNFL thickness\r<br> on OCT <LLN in at least one eye OR documented VEP latency in at least 1 eye.\r<br>\r<br> - Cranial MRI scan demonstrating T2-hyperintense lesions satisfying diagnostic criteria\r<br> for MS\r<br>\r<br> - Ability to perform the component tests of the MSFC (T25FW, 9HPT, PASAT3).\r<br>\r<br> - Ability to perform SLCLA.\r<br>\r<br> - Has given written informed consent to participate in the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia,\r<br> septicemia) within 30 days of the Screening Visit.\r<br>\r<br> - History of cancer other than basal cell carcinoma of the skin.\r<br>\r<br> - History or laboratory results indicative of any significant cardiac, endocrine,\r<br> hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary,\r<br> gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder\r<br> that in the opinion of the Principal Investigator would preclude the safe performance\r<br> of BM aspiration, infusion of autologous MSCs, or performance of any of the planned\r<br> study assessments.\r<br>\r<br> - Abnormal blood tests which exceed designated limits.\r<br>\r<br> - Positive screening tests for hepatitis B, hepatitis C, HIV 1&2, HTLV I/II, CMV, West\r<br> Nile virus, syphilis, blood parasite infection.\r<br>\r<br> - Clinically significant abnormality on chest X-ray.\r<br>\r<br> - Clinically significant abnormality on EKG.\r<br>\r<br> - Oxygen-saturation <90% on room air.\r<br>\r<br> - History of alcohol or drug abuse within one year.\r<br>\r<br> - Any metallic material or electronic device in the body, or condition that precludes\r<br> the participant from undergoing MRI with Gd administration.\r<br>\r<br> - Uncontrolled glaucoma or other ocular condition that precludes performing OCT or\r<br> interpreting the results.\r<br>\r<br> - MS relapse with onset within 30 days prior to the Screening Visit or the participant\r<br> has not stabilized from a previous relapse at the time of the Screening Visit.\r<br>\r<br> - Current treatment with an investigational MS disease therapy.\r<br>\r<br> - Prior treatment with:\r<br>\r<br> Total lymphoid irradiation. Cladribine. T-cell or T-cell receptor vaccination. Campath-1h\r<br> (alemtuzumab). Rituxan (rituximab).\r<br>\r<br> - Prior treatment within three months with:\r<br>\r<br> Tysabri (natalizumab). Gilenya (Fingolimod/FTY720). Zenapax (daclizumab). Cytoxan\r<br> (cyclophosphamide). Novantrone (mitoxantrone). Cyclosporine. CellCept (mycophenolate\r<br> mofetil). Imuran (azathioprine). Rheumatrex (methotrexate). IV gamma globulin. Plasma\r<br> exchange.\r<br>\r<br> - Prior treatment within one month:\r<br>\r<br> Systemic corticosteroids with daily dose equivalent to Prednisone 60 mg or greater.\r<br>\r<br> - Female participants who are not post-menopausal for at least one year, not surgically\r<br> sterile, or not willing to practice effective contraception.\r<br>\r<br> - Nursing mothers, pregnant women, or women planning to become pregnant during the\r<br> study.\r<br>\r<br> - Male participants who are not willing to practice effective contraception.\r<br>\r<br> - Unwillingness or inability to comply with the requirements of this protocol including\r<br> the presence of any condition (physical, mental, or social) that, in the opinion of\r<br> the Principal Investigator, is likely to affect the participant's ability to comply\r<br> with the study protocol.\r<br>\r<br> - Any other reason that, in the opinion of the Principal Investigator, makes the\r<br> participant unsuitable for participation in the study.\r<br>", "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": "2024-05-13T00:00:00Z", "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": "<br> Female: yes<br> Male: yes<br>", "date_enrollement": "2009-01-22", "target_size": "1738", "study_type": "Interventional clinical trial of medicinal product", "study_design": "<br> Controlled: no<br> Randomised: no<br> Open: yes<br> Single blind: no<br> Double blind: no<br> Parallel group: no<br> Cross over: no<br> Other: no<br> If controlled, specify comparator, Other Medicinial Product: no<br> Placebo: no<br> Other: no<br> Number of treatment arms in the trial: 1<br>", "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": "[email protected]", "contact_tel": null, "contact_affiliation": "Biogen Idec Limited", "inclusion_criteria": "Inclusion criteria: <br> 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<br> \r<br> 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<br> \r<br> 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.<br> Are the trial subjects under 18? no<br> Number of subjects for this age range:<br> F.1.2 Adults (18-64 years) yes<br> F.1.2.1 Number of subjects for this age range 1738<br> F.1.3 Elderly (>=65 years) no<br> F.1.3.1 Number of subjects for this age range<br>", "exclusion_criteria": "Exclusion criteria: <br> 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<br> \r<br> 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<br> \r<br> 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<br> \r<br> 4. History of malignancy.\r<br> \r<br> 5. History of severe allergic or anaphylactic reactions.\r<br> \r<br> 6. Alanine transaminase (ALT), aspartate transaminase (AST), or\r<br> gamma-glutamyltransferase (GGT) >3 times the upper limit of normal (ULN).\r<br> \r<br> 7. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.\r<br> \r<br> 8. Previous participation in this study (109MS303).\r<br> \r<br> 9. Unwillingness or inability to comply with the requirements of the\r<br> 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<br> \r<br> 10. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.<br>", "condition": "Relapsing-Remitting Multiple Sclerosis <br>\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": "<br> Product Name: BG00012<br> Product Code: BG00012<br> Pharmaceutical Form: Capsule, hard<br> INN or Proposed INN: Dimethyl Fumarate<br> CAS Number: 624497<br> Current Sponsor code: BG00012<br> Other descriptive name: DIMETHYL FUMARATE<br> Concentration unit: mg milligram(s)<br> Concentration type: equal<br> Concentration number: 120-<br><br>", "primary_outcome": "Main Objective: To evaluate the long-term safety profile of BG00012.;<br> Secondary Objective: To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (Expanded Disability Status Scale).<br> <br> 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).<br> <br> To evaluate the long-term effects of BG00012 on health economics<br> 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.<br> ;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).;<br> Secondary end point(s): • To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (EDSS).\r<br> \r<br> • To evaluate further the long-term effects of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (EDSS).\r<br> • 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<br> \r<br> • 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.<br>", "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": "2024-05-13T00:00:00Z", "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": "<br>Female: yes<br>Male: yes<br>", "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: <br>Inclusion Criteria<br>Subjects are eligible to be included in the study only if they meet all of the following<br>criteria:<br>[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).<br>[2] A Kurtzke EDSS (Kurtzke 1983) score of 0 through 5.0. This would include subjects who are ambulatory.<br>[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.<br>[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<br>(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).<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>•Have MS categorized as primary progressive, secondary progressive or progressive relapsing. <br>•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. <br>•Have greater than 15 Gd-enhancing lesions of the brain by MRI performed between Visits 1 and 2.<br>•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. <br>•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. <br>•Have had elective surgery within 2 weeks prior to randomization or are scheduled to have 1 during the study. <br>•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.. <br>•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. <br>•Have uncontrolled arterial hypertension characterized by a systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg. <br>•Have known hypogammaglobulinemia or a serum IgG, IgM, or IgA concentration less than the lower limit of the reference range. <br>•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. <br>•Have contraindications for MRI: pacemakers or other containdicated implanted metal devices, allergy to gadolinium, of", "condition": "Relapsing-Remitting Multiple Sclerosis <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Name: LY2127399<br>Product Code: LY2127399<br>Pharmaceutical Form: Powder for solution for injection<br>INN or Proposed INN: N/a<br>CAS Number: N/a<br>Current Sponsor code: LY2127399<br>Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 4-120<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intravenous use<br><br>", "primary_outcome": "Main Objective: Primary Objective<br>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:<br>Safety/tolerability of LY2127399 (LY) compared to placebo.<br>Whether Total:<br>number of Gd-enhancing MRI lesions,<br>number of new Gd-enhancing MRI lesions,<br>number of new or newly enlarging T2-weighted MRI lesions, and<br>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.<br>Whether the time to first relapse is statistically significantly longer in 1 or more LY groups compared to placebo.<br>Whether the proportion of relapse-free subjects is greater, and whether there is a<br>smaller annualized relapse rate over 24 and 48 weeks in =1 LY group compared to placebo.<br>Proportion of subjects with anti-LY antibodies at the end of the study.<br>PD of selected peripheral B cell subsets following administration of LY compared to placebo.<br>Serum PK of LY after multiple doses.<br>Effect of treatment with LY compared to placebo on EDSS, MSFC, VAS of Wellbeing, SF-36, and QIDS-SR16.<br>;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": "2024-05-13T00:00:00Z", "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<br>2. Age range over 18 years, male or female", "exclusion_criteria": "Exclusion criteria: 1. Bowel cancer<br>2. Stoma<br>3. Abdominal surgery (inside last year)", "condition": "Multiple sclerosis <br>Nervous System Diseases <br>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: <br>1. Constipation Scoring System<br>2. Neurogenic Bowel Dysfunction Score<br>3. Bowel Diary<br>4. 29-item Multiple Sclerosis Impact Scale (MSIS-29)<br>5. Qualiveen Questionnaire<br><br>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. <br><br>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<br>2. Bowel Diary<br>3. Qualiveen Questionnaire<br>4. 29-item Multiple Sclerosis Impact Scale (MSIS-29)<br><br>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": 302 } ], "export_date": "2024-05-13T00:00:00Z", "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": "2009-03-13", "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": "<br> Key Inclusion Criteria:\r<br>\r<br> Participants are eligible to be screened for this study if all of the following criteria\r<br> are met:\r<br>\r<br> - Patient must meet all prescribing criteria for TYSABRI® and eligible for the TOUCH™\r<br> program.\r<br>\r<br> - If utilizing medications for symptoms of bladder dysfunction (such as incontinence,\r<br> urgency etc), subjects will need to remain on a stable dose of medication(s) for at\r<br> least one month prior to and for duration of study.\r<br>\r<br> - If utilizing medications that affect urinary output (e.g. anticholinergics,\r<br> diuretics, etc.), subjects will need to remain on a stable dose of medication(s) for\r<br> at least one month prior to study entry and for the duration of the study.\r<br>\r<br> - Able to provide written informed consent.\r<br>\r<br> - Patient must be willing to maintain current hydration habits and caffeine intake for\r<br> the duration of the study.\r<br>\r<br> Participants will be selected for enrollment if all of the following criteria are met:\r<br>\r<br> - Screening Visit urinary incontinence defined as:\r<br>\r<br> - Greater than or equal to 3 incontinence episodes per week or greater than or equal\r<br> to 8 micturitions per day (both mean numbers).\r<br>\r<br> - Screening Visit score on the UDI-6 of more than or equal to 6.\r<br>\r<br> - Screening Visit EDSS 0 - 6.5\r<br>\r<br> Key Exclusion Criteria:\r<br>\r<br> Candidates will be excluded from study screening if any of the following exclusion\r<br> criteria exist:\r<br>\r<br> - Primary progressive, secondary progressive, or progressive relapsing MS. Primary\r<br> progressive, secondary progressive or progressive relapsing multiple sclerosis are\r<br> defined by Lublin and Reingold (Lublin and Reingold, 1996) or EDSS >6.5.\r<br>\r<br> - Current or previous history of Progressive Multifocal Leukencephalopathy (PML).\r<br>\r<br> - A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia,\r<br> septicemia) within 30 days.\r<br>\r<br> - History of recurrent or chronic urinary tract infection or a urinary tract infection\r<br> within the preceding 30 days prior to Week 0 (diagnosis based on clinical history and\r<br> Screening Visit urinalysis and urine culture).\r<br>\r<br> - Patients who have in-dwelling foley catheter or a suprapubic catheter.\r<br>\r<br> - Patients with a history of symptomatic benign prostatic hyperplasia (BPH) or a\r<br> history of prostate cancer.\r<br>\r<br> - History of, or abnormal laboratory results indicative of, any significant cardiac,\r<br> endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,\r<br> gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease, that,\r<br> in the opinion of the investigator, would preclude the administration of natalizumab\r<br> for the duration of the study.\r<br>\r<br> - Subject with history of malignancy within the past 2 years, with the exception of\r<br> basal cell carcinoma that has been treated.\r<br>\r<br> - History of severe allergic or anaphylactic reactions or known drug hypersensitivity.\r<br>\r<br> - Any prior treatment with the following medications: Natalizumab (TYSABRI®)\r<br>\r<br> - Nursing mothers, pregnant women, and women planning to become pregnant while in\r<br> study.\r<br>\r<br> - Any other reasons that, in the opinion of the Investigator and/or Sponsor, the\r<br> subject is determined to be unsuitable for enrollment into this study.\r<br>\r<br> - Unwillingness or inability to comply with the requirements of this protocol including\r<br> the presence of any condition (physical, mental, or social) that is likely to affect\r<br> the subject's ability to comply with the study protocol.\r<br>\r<br> - History of alcohol or drug abuse within 2 years prior to randomization.\r<br>\r<br> - Female subjects who are not postmenopausal for at least 1 year, surgically sterile,\r<br> or willing to use a medically acceptable method of birth control during the study.\r<br> The rhythm method is not to be used as the sole method of contraception.\r<br>\r<br> Participants will be determined as screen failures if any of the following criteria apply:\r<br>\r<br> - Abnormal blood tests, performed at the screening visit, which exceed any of the\r<br> limits defined below:\r<br>\r<br> 1. ALT/ SGPT, or AST/ SGOT more than three times the upper limit of normal (i.e.,\r<br> 3xULN).\r<br>\r<br> 2. Total white blood cell (WBC) count less than 2,300/mm3.\r<br>\r<br> 3. Platelet count less than 100,000/mm3.\r<br>\r<br> 4. Creatinine more than 2xULN.\r<br>\r<br> - Screening Visit urinary incontinence defined as less than 3 incontinence episodes per\r<br> week or less than 8 micturitions per day (both mean numbers).\r<br>\r<br> - Screening Visit score on the UDI-6 of less than 6.\r<br>\r<br> - Screening Visit EDSS more than 6.5.\r<br>\r<br> NOTE: Other protocol defined inclusion/exclusion criteria may apply.\r<br>", "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 } ] }