{"count":4801,"next":"http://api.gregory-ms.com/trials/?page=3","previous":"http://api.gregory-ms.com/trials/","results":[{"trial_id":4309,"title":"A Study to Evaluate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis","summary":null,"published_date":"2021-09-14T00:00:00Z","discovery_date":"2024-03-22T13:17:27.769324Z","link":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-003772-14","source":"WHO XML import","relevant":null,"identifiers":{"euctr":"EUCTR2021-003772-14-SK"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13811843","last_refreshed_on":"2024-03-18","scientific_title":"A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO\nINVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS","primary_sponsor":"F. Hoffmann-La Roche Ltd","retrospective_flag":"Yes","date_registration":null,"source_register":"EU Clinical Trials Register","recruitment_status":"Authorised","other_records":"Yes","inclusion_agemin":null,"inclusion_agemax":null,"inclusion_gender":"
Female: yes
Male: yes
","date_enrollement":"2021-08-12","target_size":"102","study_type":"Interventional clinical trial of medicinal product","study_design":"Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2","phase":"Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): no","countries":"Czech Republic;Morocco;Czechia;Norway;Japan;Egypt;Slovakia;Slovenia;Kenya;Serbia;Croatia","contact_firstname":"Trial Information Support Line-TISL","contact_lastname":null,"contact_address":"Grenzacherstrasse 124","contact_email":"global.rochegenentechtrials@roche.com","contact_tel":null,"contact_affiliation":"F. Hoffmann-La Roche Ltd","inclusion_criteria":"Inclusion criteria:
• Participants who are aged 18 to 55 years inclusive at the time of signing Informed Consent Form
• A diagnosis of relapsing MS (RMS) in accordance with the revised 2017 McDonald Criteria and one of the following:
o At least two documented clinical relapses within the last 2 years or one documented clinical relapse within 12 months of screening (but not within the 30 days prior to screening)
o Documented evidence of the presence of at least one T1 Gd+ lesion on MRI in the 6 months prior to randomization (may include the screening MRI)
• Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points
• For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs during the treatment period and for 28 days after the final dose of fenebrutinib
• For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 28 days after the final dose of fenebrutinib to avoid exposing the embryo
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 102
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
","exclusion_criteria":"Exclusion criteria:
•Disease duration of >10 years from the onset of symptoms and an EDSS score at screening <2.0
•A diagnosis of primary progressive MS or non-active secondary progressive MS
•Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to or during screening or treatment with oral anti-microbials within 2 weeks prior to or during screening
•History of progressive multifocal leukoencephalopathy (PML)
•History of cancer
•Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy >1 year prior to screening is not exclusionary
•Presence of other neurological disorders that could interfere with the diagnosis of MS or with the assessments of efficacy or safety during the study
•Evidence of clinically significant psychiatric, pulmonary, renal, hepatic, metabolic, gastrointestinal (GI), or cardiovascular disease, or endocrine disease
•Presence of the New York Heart Association Class III and Class IV criteria for congestive heart failure
•Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results
•Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT
•History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
•Participants undergoing dialysis or estimated glomerular filtration rate <60 mL/min/1.73 m^2
•Any of the following laboratory results: ALT or AST >2*upper limit of normal (ULN); Total bilirubin greater than 1.5*ULN; Hemoglobin <9.5 grams/deciliter; White blood cell count <2000 cells/mm^3 (µL); Platelet count <100*10^9/L; Absolute neutrophil count <=1500 cells/mm^3 (µL); IgG<500 mg/dL
•Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the 12-week double-blind study period
•History of alcohol or other drug abuse within 12 months prior to screening
•Positive screening tests for hepatitis B
•Positive screening tests for hepatitis C
•Evidence of active, latent or inadequately treated infection with tuberculosis
•Clinically significant abnormalities in hepatic synthetic function tests
•History of hospitalization or transfusion for a GI bleed
•Known bleeding diathesis
•Any condition possibly affecting oral drug absorption
•History of or currently active primary or secondary (non-drug-related) immunodeficiency
•Inability to complete an MRI scan or contraindication to Gd administration
•Any previous history of organ transplantation
•Any previous treatment with bone marrow transplantation or hematopoietic stem cell transplantation
•Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening or during the screening period. Inhaled and topical corticosteroids are allowed.
•Receiving an unstable dosing regimen of proton pump inhibitors or H2-receptor antagonist during the screening phase and/or no plan to remain at a stable dose for the duration of study treatment
•Treatment with IVIg or plasmapheresis within 12 weeks prior to randomization
•Sensitivity or intolerance to any ingredient of fenebrutinib
•Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
•Need for systemic anticoagulation (ora","condition":"Relapsing Multiple Sclerosis
MedDRA version: 20.0\nLevel: PT\nClassification code 10048393\nTerm: Multiple sclerosis relapse\nSystem Organ Class: 10029205 - Nervous system disorders\n
MedDRA version: 21.0\nLevel: PT\nClassification code 10080700\nTerm: Relapsing multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders\n;Therapeutic area: Diseases [C] - Immune System Diseases [C20]","intervention":"
Product Name: Fenebrutinib
Product Code: RO7010939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FENEBRUTINIB
Current Sponsor code: RO7010939
Other descriptive name: GDC-0853
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
","primary_outcome":"Main Objective: • To evaluate the efficacy of fenebrutinib compared with placebo on the
total number of new gadolinium enhancing T1 magnetic resonance
imaging (MRI) lesions;Secondary Objective: • To evaluate the effect of fenebrutinib on MRI lesions
• To evaluate the safety of fenebrutinib compared with placebo
• To characterize the fenebrutinib pharmacokinetics (PK) profile;Primary end point(s): 1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 4, 8, and 12;Timepoint(s) of evaluation of this end point: 1. At Weeks 4, 8, and 12","secondary_outcome":"Secondary end point(s): 1.Total number of new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12
2.Proportion of participants free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12
3.Incidence and severity of adverse events
4.Change from baseline in vital signs
5.Change from baseline in targeted clinical laboratory test results
6.Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale
7.Plasma concentration of fenebrutinib at specified timepoints;Timepoint(s) of evaluation of this end point: 1-2. At Weeks 4, 8, and 12
3. From the start of treatment until 28 days after the final dose of study treatment
4-5. Double blind period: Baseline (Week 0) to Week 12; Open label period: Baseline (Week 0) to Week 192
6. Double blind period: At Baseline (Day -28 to Day -1), Weeks 4, 8 and 12; Open label period: Baseline (Week 0), Weeks 12, 24, 48, and every 24 weeks thereafter up to week 192.
7.\tAt Days 1, 29, 57, 85, at early discontinuation visit
","secondary_id":"GN43271;2021-003772-14-CZ","source_support":"F. Hoffman-La Roche Ltd.","ethics_review_status":"Approved","ethics_review_approval_date":"2021-06-10","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":4308,"title":"Remote Therapeutic Monitoring Exercise Tracking","summary":"Conditions: Parkinson Disease; Multiple Sclerosis\n
Interventions: Device: Activity Monitoring\n
Sponsors: Shirley Ryan AbilityLab\n
Not yet recruiting","published_date":"2024-02-22T00:00:00Z","discovery_date":"2024-03-22T13:17:17.544191Z","link":"https://clinicaltrials.gov/ct2/show/NCT06306768","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT06306768","euct":null,"eudract":null},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13809784","last_refreshed_on":"2024-03-18","scientific_title":"Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.","primary_sponsor":"Shirley Ryan AbilityLab","retrospective_flag":"Yes","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Not recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"89 Years","inclusion_gender":"All","date_enrollement":"2024-03-01","target_size":"200","study_type":"Interventional","study_design":"Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).","phase":"N/A","countries":null,"contact_firstname":";","contact_lastname":"Miriam Rafferty, PT, PhD;Miriam Rafferty, PT, PhD","contact_address":null,"contact_email":";mrafferty@sralab.org","contact_tel":";312-238-7233","contact_affiliation":"Shirley Ryan AbilityLab;","inclusion_criteria":"
Inclusion Criteria:\r
\r
- Are ambulatory as their primary means of mobility without an assistive device except\r
for single point cane or walking sticks in community\r
\r
- Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or\r
Multiple Sclerosis\r
\r
- Personal goal and willingness to address physical activity\r
\r
- Have a smart phone (Datos Health app is compatible with any Smart phone device)\r
\r
- Willing to accept Datos' Terms and Conditions\r
\r
Exclusion Criteria:\r
\r
- Individuals with cognitive or communication disorders (including dementia) which would\r
limit their ability to interact with the RTM\r
","exclusion_criteria":null,"condition":"Parkinson Disease;Multiple Sclerosis","intervention":"Device: Activity Monitoring","primary_outcome":"Physical Activity Metric 1;Physical Activity Metric 2","secondary_outcome":"Exercise Self Efficacy;Quality of Life from PROMIS 10-b;Quality of Life from PROMIS-29","secondary_id":"STU00219979","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":4307,"title":"Motor-cognitive Performance in People With Multiple Sclerosis","summary":"Conditions: Multiple Sclerosis; Postural Balance\n
Interventions: Other: HiBalance-MS\n
Sponsors: Karolinska Institutet; Karolinska University Hospital\n
Recruiting","published_date":"2024-03-15T04:00:00Z","discovery_date":"2024-03-22T13:17:17.499970Z","link":"https://clinicaltrials.gov/study/NCT06312046?cond=Multiple+Sclerosis","source":"Clinical Trials.gov","relevant":null,"identifiers":{"nct":"NCT06312046","euct":null,"eudract":null},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13819073","last_refreshed_on":"2024-03-25","scientific_title":"Motor-cognitive Performance in People With Multiple Sclerosis - Brain Activity and Effects of Balance Exercise","primary_sponsor":"Karolinska Institutet","retrospective_flag":"No","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"65 Years","inclusion_gender":"All","date_enrollement":"2024-02-26","target_size":"90","study_type":"Interventional","study_design":"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).","phase":"N/A","countries":"Sweden","contact_firstname":"; ;","contact_lastname":"Sverker Johansson, Ph.D;Compliance Office Karolinska Institutet;Sverker Johansson, Ph.D","contact_address":null,"contact_email":";compliance@ki.se;sverker.johansson@ki.se","contact_tel":";+46852480000;+46702861260","contact_affiliation":"Karolinska Institutet, org.nr 202100-2973;","inclusion_criteria":"
Inclusion Criteria:\r
\r
- an MS diagnosis according to McDonald criteria;\r
\r
- an overall MS-disability score from 2.0 to 5.5 according to the Expanded Disability\r
Status Scale;\r
\r
- ability to walk 100 m without aid;\r
\r
- a maximum score of 24 in the Mini-BESTest (i.e., < 25 points)\r
\r
- 18 to 65 years of age\r
\r
Exclusion Criteria:\r
\r
- cognitive impairment as indicated by a score <21 in the Montreal Cognitive Assessment;\r
\r
- presence of other conditions that would substantially influence balance;\r
\r
- an MS relapse or change of disease-modifying treatment within the past 8 weeks\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis;Postural Balance","intervention":"Other: HiBalance-MS","primary_outcome":"Mini Balance Evaluation Systems test.","secondary_outcome":"10-Meter Walk Test, maximum speed.;10-Meter Walk Test, self-selected speed.;2-Minute Walk Test, self-selected speed.;Gait speed during simultaneous dual task performance.;Stride length during dual task gait performance.;Step time during dual task gait performance.;Response errors in dual task cognitive performance;Reaction time in dual task cognitive performance;Six-Spot Step Test.;Completion time in the Trail Making Test.;Number of errors in the Trail Making Test.;Immediate and delayed recall in the Ray Auditory Verbal Learning Test.;Cognitive processing speed in the Symbol Digit Modalities Test.;Cognitive function - composite measure of three cognitive tests.;Physical activity level.;Physical activity level, self-reported.;Physical exercise habits, self-reported.;The generic Walk-12 questionnaire.;Falls Efficacy Scale - International.;Assesment of anxiety with the Hospital Anxiety and Depression Scale.;Assesment of depression with the Hospital Anxiety and Depression Scale.;Modified Fatigue Impact Scale.;Occupational Gap Questionnaire.;Acceptance of Chronic Health Condition scale.;Multiple Sclerosis Impact Scale - physical impact.;Multiple Sclerosis Impact Scale - psychological impact.;Euroqol-5 Dimensions-5 Level (EuroQoL-5D-5L).;Euroqol Visual Analogue Scale (EQ VAS).;World Health Organization Disability Assessment Schedule, version 2.0. (WHODAS 2.0)","secondary_id":"2018 374-31","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":4306,"title":"Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis","summary":"Conditions: Multiple Sclerosis, Relapsing-Remitting\n
Interventions: Other: personalized combined physical and cognitive intervention\n
Sponsors: Fondazione Don Carlo Gnocchi Onlus; Careggi Hospital; Sheba Medical Center; Uppsala University\n
Recruiting","published_date":"2024-04-03T00:00:00Z","discovery_date":"2024-03-22T13:17:17.479478Z","link":"https://clinicaltrials.gov/ct2/show/NCT06303024","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT06303024","euct":null,"eudract":null},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13809498","last_refreshed_on":"2024-03-18","scientific_title":"Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis at High Risk of disEase Acitivity Through a Preventive personaLised and InnovAtive rehaBiLitation stratEgy. (RELIABLE)","primary_sponsor":"Fondazione Don Carlo Gnocchi Onlus","retrospective_flag":"No","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"N/A","inclusion_gender":"All","date_enrollement":"2023-06-14","target_size":"140","study_type":"Interventional","study_design":"Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).","phase":"N/A","countries":"Italy","contact_firstname":";","contact_lastname":"Maria Pia Amato, Prof;Maria Pia Amato, Prof","contact_address":null,"contact_email":"mpamato@dongnocchi.it;mpamato@dongnocchi.it","contact_tel":"0557947836;0557947836","contact_affiliation":null,"inclusion_criteria":"
Inclusion Criteria:\r
\r
- diagnosis of RRMS based on the 2017 McDonald criteria;\r
\r
- age = 18 years;\r
\r
- EDSS = 2.0;\r
\r
- disease duration = 5 years;\r
\r
- verification of MS subtype,\r
\r
- duration of disease and EDSS will be accomplished by obtaining a signed consent form\r
for the release of medical information from the treating neurologist.\r
\r
Exclusion Criteria:\r
\r
- history of relevant psychiatric comorbidities.\r
\r
- Severely depressed subjects assessed through the Beck Depression Inventory (scores =\r
29);\r
\r
- relapses or corticosteroid treatment in the 30 days before inclusion;\r
\r
- history of substance abuse;\r
\r
- presence of non-MS related physical or cognitive impairment that could make the\r
patient unable to complete the study assessments.\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis, Relapsing-Remitting","intervention":"Other: personalized combined physical and cognitive intervention","primary_outcome":"Symbol Digit Modalities Test (SDMT);California Verbal Learning Test second edition (CVLT-II);Brief Visuo-Spatial Memory Test- Revised (BVMT-R);Word list generation (WLG);Stroop test;Test Intelligenza Breve (TIB);9 hole peg test (9HPT);The Hospital Anxiety and Depression Scale (HADS);Beck Depression Inventory second edition;The Modified Fatigue Impact Scale (MFIS);The Multiple Sclerosis Walking Scale (MSWS-12);Multiple Sclerosis Impact Scale (MSIS-29-V2);Multiple Sclerosis Quality of Life-54 (MSQOL-54);six minutes walking test (6MWT);Romberg test;handgrip test;cognitive-motor interference;Timed 25-foot walk;brain MRI scan;International Physical Activity Questionnaire (IPAQ)","secondary_outcome":null,"secondary_id":"RELIABLE Clinical Study","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":4305,"title":"Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2","summary":"Conditions: Multiple Sclerosis\n
Sponsors: University Hospital, Basel, Switzerland\n
Not yet recruiting","published_date":"2024-06-03T00:00:00Z","discovery_date":"2024-03-22T13:17:17.443929Z","link":"https://clinicaltrials.gov/ct2/show/NCT06309173","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT06309173","euct":null,"eudract":null},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13818982","last_refreshed_on":"2024-03-25","scientific_title":"Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2","primary_sponsor":"University Hospital, Basel, Switzerland","retrospective_flag":"Yes","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Not recruiting","other_records":"No","inclusion_agemin":"18 Years","inclusion_agemax":"N/A","inclusion_gender":"All","date_enrollement":"2024-04-28","target_size":"600","study_type":"Observational","study_design":null,"phase":null,"countries":null,"contact_firstname":"","contact_lastname":"Ludwig Kappos, Prof. Dr. med.","contact_address":null,"contact_email":"Ludwig.kappos@usb.ch","contact_tel":"+41 61 265 41 69","contact_affiliation":null,"inclusion_criteria":"
Inclusion Criteria:\r
\r
- Age =18\r
\r
- Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms\r
inclusive (CIS, RRMS, SPMS, PPMS)\r
\r
- In possession of a Healios+Me app-compatible smartphone (iOS/Android)\r
\r
- Corrected close visual acuity of =0.5\r
\r
- Hand motor skills sufficient for using a smartphone\r
\r
- Ability and intention to follow the study procedures\r
\r
- Sufficient knowledge of the language for the specific country\r
\r
- Informed Consent as documented by signature\r
\r
Exclusion Criteria:\r
\r
- NA\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis","intervention":null,"primary_outcome":"Correlation of the digital features with the respective measurements of the clinical reference tests;The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables","secondary_outcome":"The ability of the digital biomarker to detect worsening in other relevant reference test results creating converging evidence;The ability of the digital biomarker to detect worsening in standard assessments used for treatment of PwMS (clinical, imaging, body fluids);The ability of the digital biomarker to detect change of Patient Reported Outcomes;The ability of the digital biomarker to detect occurrence of clinical and other meaningful events (relapses, PIRA, serious adverse events, hospitalizations, working capacity);The relationship of the digital biomarkers with imaging and body fluid markers;The relationship of the digital biomarkers with Patient Reported Outcomes","secondary_id":"0000-00000; ko23Hemkens","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":4304,"title":"Remote Evaluation in Patients With Multiple Sclerosis","summary":"Conditions: Multiple Sclerosis\n
Interventions: Other: 30 second sit and stand test\n
Sponsors: Inonu University\n
Not yet recruiting","published_date":"2024-06-03T00:00:00Z","discovery_date":"2024-03-22T13:17:17.421897Z","link":"https://clinicaltrials.gov/ct2/show/NCT06308042","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT06308042","euct":null,"eudract":null},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13809882","last_refreshed_on":"2024-03-18","scientific_title":"Remote Reliability Of 30 Seconds Sit And Stand Test In Patients With Multiple Sclerosis","primary_sponsor":"Inonu University","retrospective_flag":"Yes","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":"2024-03-11","target_size":"10","study_type":"Observational","study_design":null,"phase":null,"countries":null,"contact_firstname":";","contact_lastname":"Burcu talu;DILAN DEMIRTAS KARAOBA","contact_address":null,"contact_email":";dilandemirtas92@gmail.com","contact_tel":";0554112779","contact_affiliation":"Inonu University;","inclusion_criteria":"
Inclusion Criteria:\r
\r
- Having been diagnosed with MS according to the McDonald criteria by a neurologist\r
\r
- having and being able to use a device with Internet access (e.g. smartphone, computer\r
or tablet)\r
\r
- having EDSS between 1.5 and 6.5,\r
\r
- being between the ages of 18-65.\r
\r
Exclusion Criteria:\r
\r
- Patients who have had a recurrence of the disease in the last 30 days,\r
\r
- have an additional health problem (orthopedic, neurological, internal or\r
cardiorespiratory) that prevents standing/walking,\r
\r
- do not agree to participate in the study.\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis","intervention":"Other: 30 second sit and stand test","primary_outcome":"30 second sit and stand test","secondary_outcome":null,"secondary_id":"2024/5558","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":4303,"title":"ADAs to Alemtuzumab","summary":"Conditions: Multiple Sclerosis\n
Interventions: Drug: Alemtuzumab\n
Sponsors: Queen Mary University of London\n
Active, not recruiting","published_date":"2024-03-15T04:00:00Z","discovery_date":"2024-03-22T13:17:17.400175Z","link":"https://clinicaltrials.gov/study/NCT06310343?cond=Multiple+Sclerosis","source":"Clinical Trials.gov","relevant":null,"identifiers":{"nct":"NCT06310343","euct":null,"eudract":null},"categories":[{"category_id":2,"category_description":"LEMTRADA, or Alemtuzumab, is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.\n\nhttps://www.lemtrada.com/","category_name":"Alemtuzumab","category_slug":"alemtuzumab","category_terms":["alemtuzumab","lemtrada"],"article_count":113}],"export_date":"2024-03-28T00:00:00Z","internal_number":"13810059","last_refreshed_on":"2024-03-18","scientific_title":"A Study of a New Assay to Detect Anti-drug Antibodies to Alemtuzumab and Their Potential Impact in Multiple Sclerosis","primary_sponsor":"Queen Mary University of London","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":"All","date_enrollement":"2022-04-25","target_size":"15","study_type":"Observational","study_design":null,"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:\r
\r
1. Patients with RRMS who are being treated with alemtuzumab at Barts Health NHS Trust\r
will be approached to participate in the study.\r
\r
2. Patients must be willing and able to undergo blood tests.\r
\r
Exclusion Criteria:\r
\r
1. Ineligible for alemtuzumab under NHS England prescribing guidelines.\r
\r
2. Those unable to comply with study requirements, including frequency of visits.\r
Abnormal baseline investigations (WBC<3 x 10*9/l, lymphocytes <1.0 x 10*9/l,\r
neutrophil count <1.5 x 10*9/l, platelet count <100 x 10*9/l, haemoglobin <110 g/l,\r
LFT >/3x upper limit of normal of site reference ranges, potassium <2.8 mmol/l or >5.5\r
mmol/l, sodium /,125 mmol/l, creatinine >130 umol/l).\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis","intervention":"Drug: Alemtuzumab","primary_outcome":"To quantify the longitudinal changes in alemtuzumab ADAs","secondary_outcome":"1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2.;2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions.;3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity.;4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels;5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity.","secondary_id":"304993","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":4302,"title":"Neuropsychological evaluation and rehabilitation in multiple sclerosis – definitive randomised controlled trial (RCT) and implementation study","summary":null,"published_date":"2024-11-03T00:00:00Z","discovery_date":"2024-03-22T13:17:17.367648Z","link":"https://www.isrctn.com/ISRCTN10285713","source":"WHO XML import","relevant":null,"identifiers":{"isrctn":"ISRCTN10285713"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13820328","last_refreshed_on":"2024-03-25","scientific_title":"Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): A mixed methods pragmatic multicentre Randomised Controlled Trial (RCT) with nested health economic and process evaluations and an implementation study (Phase 3: Work Packages 4 and 5)","primary_sponsor":"Nottinghamshire Healthcare NHS Foundation Trust","retrospective_flag":"Yes","date_registration":null,"source_register":"ISRCTN","recruitment_status":"Recruiting","other_records":"No","inclusion_agemin":null,"inclusion_agemax":null,"inclusion_gender":"Both","date_enrollement":"2024-01-04","target_size":"4776","study_type":"Interventional","study_design":"Randomised; Both; Design type: Treatment, Screening, Process of Care, Psychological & Behavioural, Complex Intervention, Management of Care, Qualitative, Validation of investigation/therapeutic procedures (Treatment)","phase":"Not Applicable","countries":"England;United Kingdom;Wales","contact_firstname":null,"contact_lastname":null,"contact_address":null,"contact_email":null,"contact_tel":null,"contact_affiliation":null,"inclusion_criteria":"Inclusion criteria: All individuals: Able and willing to give consent and able to communicate in English. Participant information sheets can be provided in Welsh upon request but the standardised materials and tests to be used require communication in English since these have not yet been developed for other languages.
Part 1: People with MS:
1.1. Diagnosis of MS
1.2. Aged 18 years or above
Part 2: People with MS:
2.1. Aged 18 years or above
2.2. Diagnosis of MS
2.3. Received cognitive screening, and mild or moderate cognitive problems identified (Part 1):
Mild or moderate problems will be identified by the clinical team based on the screening scores, the clinical and contextual information collected as part of the cognitive screening, and the patient-clinician conversations on cognitive problems experienced.
Thresholds for mild and moderate cognitive problems in people with MS will be defined based on norms (WP6: compared to control participants (people without MS)) defined by Lezak (1996) on the level of performance on SST and/or WCT*:
-Mild cognitive problems: Scores of 1 SD below the mean or lower, and higher than 2 SD below the mean;
-Moderate cognitive problems: Scores of 2 SD below the mean or lower, and higher than 2.5 SD below the mean.
*People with scores in mild or moderate ranges in either cognitive test (SST and/or WCT) would be considered eligible to participate.
Part 3:
3.1. People with MS: People with MS who participated in Part 2.
3.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2.
3.3. Healthcare professionals (HCPs): Healthcare professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists, physiotherapists) delivering the NEuRoMS screening and management pathway to people with MS in Part 1.
Part 4:
4.1. People with MS: People with MS who participated in Part 2
4.2. Intervention providers: AP/Research Nurses/Assistant OT delivering the NEuRoMS pathway and intervention to people with MS in Part 1 and Part 2
4.3. HCPs: Healthcare professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists, physiotherapists) delivering the NEuRoMS screening and management pathway to people with MS in Part 1
4.4. Service commissioners: Service commissioners (or similar) working within the Clinical Commissioning Groups or Integrated Care Systems that commission new NHS services.","exclusion_criteria":"Exclusion criteria: 1. All participants: Do not have mental capacity to consent to participate in the study.
Part 2 participants only:
2.1. Currently receiving neuropsychological intervention for cognitive problems
2.2. Received NEuRoMS intervention during WP2ii or WP3.
Part 3 patient participants only:
3.1. Participated in Part 4 interviews.
Part 4 patient participants only:
4.1. Participated in Part 3 interviews.","condition":"Multiple Sclerosis
Nervous System Diseases","intervention":"Patient participants will receive the following interventions as part of this study:
Cognitive screening (Part 1): A new clinical procedure involving a self-administered, brief online screening tool (completed at home prior to clinic visit or completed in clinic prior to routine appointment) that can be administered with minimal support from clinical staff. The screen consists of computerised tasks and brief questionnaires that capture cognitive functions (information processing, attention and working memory), mood, fatigue, and self-reported cognitive function. This new clinical procedure will help identify cognitive problems and facilitate discussions about these between patients and clinicians, to encourage joint decisions about appropriate management for these problems.
NEuRoMS rehabilitation intervention (Part 2): A therapist-led, manualised psycho-education programme to teach people with MS about cognitive problems and how to manage them. Up-to 6 sessions (4 hours in total over 2-3 months period), which can be delivered in-person or remotely over videoconferencing or telephone (or in hybrid mode).","primary_outcome":"Self-reported psychological impact of MS on everyday life, measured using the Psychological Subscale of the Multiple Sclerosis Impact Scale (MSIS-Psych; Hobart et al., 2001) at baseline, 3, 6 and 12 months post randomisation. The primary endpoint is at 3 months post-randomisation.","secondary_outcome":"Outcomes for secondary objectives 1a and 1b:
1.1. Participant scores from cognitive screening measures (completed at a single time-point at screening) including an online, self-administered: Symbol Substitution Task (SST), and Word Colour Task (WCT).
1.2. Demographic, clinical features and screening usage information (e.g., time taken to complete the screening, type of device used to complete screening, setting the screening completed at, number of patients who required reminders and extra support, etc.) will be collected as part of cognitive screening (at a single-time point at screening).
Outcomes for secondary objective 1c:
1.3. Clinical data collected as part of usual care: Patient scores from the three measures from the Multiple Sclerosis Quality of Life Inventory for self-reported cognitive problems, fatigue and mental health (Ritvo et al., 1997), measured during screening as part of usual care.
Outcomes for secondary objectives 2a and 2b:
The following secondary outcome measures will be used to capture information about the patient at baseline and to assess outcomes at 3, 6 and 12 months after randomisation:
2.1. Self-reported (subjective) cognitive impairment as measured using the Perceived Deficits Questionnaire – 20-items (PDQ-20) (Sullivan et al., 1990).
2.2. Objective cognitive impairment as measured using the Symbol Substitution Task (SST). Participants’ Part 1 SST scores will be used as baseline, and SST will be repeated at 3-, 6- and 12-month follow-ups.
2.3. Quality of life as measured using the Multiple Sclerosis Impact Scale (MSIS-29; Hobart et al., 2001) and EQ-5D-5L (Herdman et al., 2011).
2.4. Mood as measured using the Patient Health Questionnaire 9-items (PHQ-9; Kroenke et al., 2001); Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006).
2.5. Function as measured using the Nottingham Extended Activities of Daily Living Scale (Nicholl et al., 2002).
2.6. Self-efficacy as measured using the Multiple Sclerosis Self-efficacy Scale (Rigby et al., 2003).
2.7. Fatigue as measured using the Modified Fatigue Impact Scale-5 item version (MFIS-5; Fisk et al., 1994; D’Souza, 2016).
2.8. Work-related issues as measured using the Multiple Sclerosis Work Difficulties Questionnaire short form (Honan et al., 2014) and a bespoke single item question asking to what extent work has been impacted by cognitive problems. For participants who are in education, a bespoke single item question will be asked to measure to what extent education has been impacted by cognitive problems.
2.9. Medication adherence as measured using a bespoke single-item question asking to what extent medication adherence has been impacted by cognitive problems.
2.10. Cost-effectiveness as measured by the:
2.10.1. Service-use questionnaire, based on a measure used in other MS trials (Lincoln et al., 2020) adapted for use in the NEuRoMS project and refined in WP3 feasibility study.
2.10.2. EQ-5D-5L (Herdman et al., 2011).
2.10.3. MSIS-8D (using MSIS-29) to derive utilities.
2.10.4. ICECAP-A (ICEpop CAPability measure for Adults; (Al-Janabi, N Flynn, & Coast, 2012)) measure of capability and wellbeing for health economic evaluation.
Please note: MSIS-29 and EQ-5D-5L will be collected only once per time point, but will be used for two purposes: 1) for clinical evaluation, and 2) for cost-effectiveness evaluation.
2.11. Goal attainment, measured using the Goal Attainment Scale at 3, 6 and 12 months after randomisation for goals set at baseline.
Outcomes for secondary objectives 3a, 3b, 3c and 3d:
Process evaluation is assessed throughout the screening pathway and intervention delivery and Part 3 data collection period by:
3.1. The qualitative data collected through interviews with patients, healthcare professionals and intervention providers, audio-/video-recordings of intervention sessions and session record forms, and notes from monthly teleconferences/videoconferences with study site teams and supervision sessions with intervention providers on: a) Experiences of cognitive screening and management pathway and the intervention, b) Factors facilitating or hindering engagement with the pathway and the intervention, c) Resources and mechanisms considered important in delivering key outcomes, d) Experiences of how the pathway and the intervention were delivered/received and they are working, e) Any unintended consequences/outcomes of the pathway and the intervention, f) Acceptability of the intervention, g) Content of usual care, h) Intervention providers’ readiness to deliver the NEuRoMS rehabilitation intervention following training.
3.2. The level of satisfaction with the pathway and intervention, measured using the NEuRoMS pathway satisfaction questionnaire at Part 3 interview.
3.3. Intervention record forms completed by intervention providers for each intervention session to describe the number of intervention sessions, frequency, and duration.
Outcomes for secondary objective 3e:
Fidelity of the intervention, measured throughout intervention delivery, as assessed by:
3.4. The content of intervention sessions and quality of intervention delivery, through intervention record forms, audio-/video-recordings of intervention sessions, and case notes of interventions
3.5. Contextual and process issues related to intervention delivery, assessed by a review of case notes, intervention record forms, audio-/video-recordings of intervention sessions, and through monthly supervision sessions with the NEuRoMS therapists and the Part 3 and Part 4 interviews with intervention providers.
Outcomes for secondary objectives 4a, 4b, 4c and 4d
4.1. Process of implementation measured by the qualitative data collected through interviews with patients, HCPs, intervention providers and service commissioners (or similar), observations, and notes from monthly teleconferences/videoconferences with study site teams and supervision sessions with intervention providers on: a) Facilitators and barriers to implementation of the pathway and the intervention, and b) Views and experiences of how the intervention is understood and implemented in differing contexts (in terms of service configuration, socioeconomic context, etc.).","secondary_id":"Nil known;Nil known;CPMS 58780, IRAS 325421, NIHR PGfAR no. RP-PG-0218-20002","source_support":"National Institute for Health and Care Research","ethics_review_status":"Approved","ethics_review_approval_date":"2023-07-11","ethics_review_contact_name":"gmwest.rec@hra.nhs.uk","ethics_review_contact_address":"North West – Greater Manchester West Research Ethics Committee; ref: 23/NW/0272","ethics_review_contact_phone":"+44 207 104 8278","ethics_review_contact_email":"gmwest.rec@hra.nhs.uk","results_date_completed":"2027-06-30","results_url_link":null},{"trial_id":4301,"title":"Étude multicentrique, randomisée en double aveugle versus placebo évaluant l’efficacité d’un traitement par Cholécalciférol (Vitamine D3) pour retarder la conversion en SEP après un syndrome cliniquement isolé (SCI)","summary":null,"published_date":"2015-09-15T00:00:00Z","discovery_date":"2024-03-13T11:02:06.256493Z","link":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000910-40","source":"WHO XML import","relevant":null,"identifiers":{"euctr":"EUCTR2013-000910-40-FR"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13800627","last_refreshed_on":"2024-03-12","scientific_title":"Étude multicentrique, randomisée en double aveugle versus placebo évaluant l’efficacité d’un traitement par Cholécalciférol (Vitamine D3) pour retarder la conversion en SEP après un syndrome cliniquement isolé (SCI) - D-Lay MS","primary_sponsor":"CHU de Nîmes","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":"2013-12-04","target_size":"316","study_type":"Interventional clinical trial of medicinal product","study_design":"Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2","phase":"Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): no\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): yes","countries":"France","contact_firstname":"Brigitte LAFONT","contact_lastname":null,"contact_address":"place du Pr. Debré","contact_email":"drc@chu-nimes.fr","contact_tel":"33466686715","contact_affiliation":"CHU de Nîmes","inclusion_criteria":"Inclusion criteria:
•\tLe patient est âgé de 18 à 50 ans et a présenté un SCI classique ayant débuté il y a moins de 60 jours\r
•\tLe patient a une IRM cérébro-médullaire montrant une démyélinisation remplissant les critères de dissémination spatiale de Swanton (2006) :\r
o\tAu moins 1 lésion dans au moins 2 des 4 territoires suivants :\r
?\tPéri-ventriculaire\r
?\tJuxta-corticale\r
?\tSous-tentorielle\r
?\tMédullaire\r
•\tPossibilité de remplir également les critères de dissémination temporelle définis selon les critères de McDonald 2010 (Polman et al. 2011) , car cette condition n’est pas suffisante pour introduire un traitement de fond à ce jour :\r
o\tPrésence simultanée d’au moins une lésion asymptomatique prenant le contraste et d’au moins une lésion asymptomatique ne prenant pas le contraste après injection de gadolinium.\r
•\tAbsence d’autre pathologie suspectée\r
•\tTaux de vitamine D sanguin inférieur à 100 nmol/l lors de la visite de pré- inclusion (VPré) (dosage en routine).\r
•\tLes femmes en âge de procréer doivent utiliser une méthode de contraception très efficace pendant toute la durée de l'étude. Une méthode de contraception très efficace est définie comme une méthode se traduisant par un faible taux d'échec (c'est-à-dire inférieur à 1 % par an) en cas d'utilisation régulière et correcte, telle que implants, contraceptifs injectables, contraceptifs oraux combinés, stérilet, abstinence sexuelle ou partenaire vasectomisé.\r
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 316
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
","exclusion_criteria":"Exclusion criteria:
•\tLa patiente est enceinte, parturiente ou elle allaite\r
•\tMaladie médicale ou psychiatrique majeure qui, selon l'investigateur, ferait courir un risque au sujet ou pourrait compromettre le respect du protocole d'étude. \r
•\tInsuffisance en vitamine D liée à des maladies digestives ou générales (maladie cœliaque, maladie inflammatoire de l'intestin, dérivation intestinale, syndrome de l'intestin court, cirrhose, syndrome néphrotique, hyperthyroïdie, rachitisme, hypoparathyroïdie, cancer, maladies granulomateuses et lymphomes) actuellement évolutives. \r
•\tInsuffisance rénale modérée ou sévère (clairance de créatinine inférieure à 60 ml/min).\r
•\tÉpilepsie non contrôlée de manière adéquate par le traitement. \r
•\tToute maladie nécessitant un traitement chronique par corticothérapie générale au long cours. \r
•\tPatient ostéoporotique ou présentant une ostéopénie connue.\r
•\tPathologie nécessitant des apports calciques supérieurs à 1 gramme par jour.\r
•\tHypercalcémie actuelle ou passée.\r
•\tPrise de médicaments qui influencent le métabolisme de la vitamine D autres que les corticoïdes, par exemple anticonvulsivants [phénobarbital, primidone, phénytoïne], rifampicine, isoniazide, kétoconazole, 5-FU et leucovorine, diurétiques thiazidiques.\r
•\tSituations s'accompagnant d'une vulnérabilité accrue à l'hypercalcémie, par exemple arythmie ou maladie cardiaque connue, traitement par digitaliques, et sujets souffrant de lithiase rénale. \r
•\tContre-indications à la vitamine D3 telles que mentionnées dans le RCP de la spécialité UVEDOSE ?.\r
•\tHypersensibilité connue au gadolinium et / ou impossibilité connue à se soumettre à une IRM cérébro-médullaire (pace-maker, matériel d’ostéosynthèse, éclat de métal intra-oculaire….).\r
","condition":"Les patients âgés de 18 à 50 ans ayant présenté depuis moins de 60 jours un SCI typique (NORB, myélite, syndrome du tronc cérébral ou sus-tentoriel) avec présence à l’IRM cérébro-médullaire de plusieurs lésions évocatrices de SEP remplissant les critères de dissémination spatiale de Swanton (SCI à haut risque de SEP) et insuffisance en vitamine D (taux = 100 nmol/L) se verront proposer de participer à la recherche.
MedDRA version: 18.0\nLevel: LLT\nClassification code 10028247\nTerm: Multiple sclerosis like syndrome\nSystem Organ Class: 100000004852\n;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]","intervention":"
Trade Name: UVEDOSE 2,5mg (100000UI)
Product Name: UVEDOSE
Pharmaceutical Form: Oral solution in single-dose container
Pharmaceutical form of the placebo: Oral solution in single-dose container
Route of administration of the placebo: Oral use
","primary_outcome":"Main Objective: L’objectif principal de cette étude est L’objectif principal de cette étude est d’évaluer l’efficacité et la tolérance sur 2 ans d’un traitement par Cholécalciférol (Vitamine D3) chez des patients ayant présenté un syndrome cliniquement isolé à haut risque de SEP (SCI). Cette efficacité sera mesurée par comparaison du risque de conversion en SEP rémittente dans les 2 ans après le SCI en appliquant les critères de McDonald (nouvelles lésions sur les IRM cérébro-médullaires de suivi ou nouvelles poussée de SEP) (McDonald et al. 2001; Polman et al. 2005), entre le groupe recevant le Cholécalciférol et le groupe recevant le placebo.;Secondary Objective: A.évaluer l’efficacité clinique sur les poussées.
B.évaluer l'efficacité sur les paramètres d’imagerie
C.évaluer l'efficacité sur le ralentissement de la progression du handicap
D.mesurer et évaluer les aptitudes cognitives
E.évaluer les changements de qualité de vie
F.évaluer la tolérance au traitement
G.corréler la variation des paramètres cliniques et d’imagerie au taux initial et à l’évolution du taux de 25(OH)D2 et 25(OH)D3 sous traitement
H.établir une biobanque à partir d’ADN et réaliser des analyses du polymorphisme des gènes impliqués dans le métabolisme de la vitamine D et le système HLA en fonction de l’augmentation du taux de vitamine D après supplémentation
I.établir une biobanque à partir des prélèvements de LCR, de plasma, de sérum et d’ARN (patients des centres CRB) en vue de la recherche de biomarqueurs pronostiques de conversion
J.établir une biobanque à partir des tubes de plasma recueillis pour le dosage de 25-hydroxy-vitamine D
;Primary end point(s): Conversion en SEP définie selon les critères de McDonald 2005 (Polman et al. 2005)
Délai de conversion en SEP définie selon les critères de McDonald 2005 (Polman et al. 2005);Timepoint(s) of evaluation of this end point: Conversion en SEP et Délai de conversion en SEP: 24 mois","secondary_outcome":"Secondary end point(s): Le nombre de poussées post-SCI \r
Nombre de nouvelles lésions FLAIR\r
Suivi fonctionnel: score EDSS\r
Qualité de vie (questionnaires EQ-5D, SF36, FSMC, Marina-SEP, HADS)\r
Tolérance au traitement\r
;Timepoint(s) of evaluation of this end point: Le nombre de poussées post-SCI : 24 mois\r
Nombre de nouvelles lésions FLAIR: 3,12,24 mois\r
Suivi fonctionnel: score EDSS: J0, 3,12,24 mois et si 2ème poussée\r
Qualité de vie (questionnaires EQ-5D, SF36, FSMC, Marina-SEP, HADS): J0,3,12,24 mois \r
Tolérance au traitement: J0, 3,6,12,18,24 mois et si 2ème poussée","secondary_id":"PHRC-N/2012/ET-01","source_support":"DGOS","ethics_review_status":"Approved","ethics_review_approval_date":"2013-06-03","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":4300,"title":"Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target","summary":null,"published_date":"2019-12-02T00:00:00Z","discovery_date":"2024-03-13T11:01:52.779743Z","link":"https://clinicaltrials.gov/ct2/show/NCT03850301","source":"WHO XML import","relevant":null,"identifiers":{"nct":"NCT03850301"},"categories":[],"export_date":"2024-03-28T00:00:00Z","internal_number":"13803063","last_refreshed_on":"2024-03-18","scientific_title":"An Experimental Medicine Study to Validate the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target in Multiple Sclerosis","primary_sponsor":"Imperial College London","retrospective_flag":"No","date_registration":null,"source_register":"ClinicalTrials.gov","recruitment_status":"Recruiting","other_records":"No","inclusion_agemin":"35 Years","inclusion_agemax":"65 Years","inclusion_gender":"All","date_enrollement":"2018-01-01","target_size":"44","study_type":"Interventional","study_design":"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor).","phase":"N/A","countries":"United Kingdom","contact_firstname":"; ;","contact_lastname":"Paul Matthews, PhD;David Owen, PhD;Richard Nicholas, PhD","contact_address":null,"contact_email":";d.owen@imperial.ac.uk;r.nicholas@imperial.ac.uk","contact_tel":";07801140800;","contact_affiliation":"Imperial College London;","inclusion_criteria":"
Inclusion Criteria:\r
\r
1. Capable of giving written informed consent, which includes compliance with the\r
requirements and restrictions listed in the consent form.\r
\r
2. Aged 35-65 years old\r
\r
3. A female subject is eligible to participate if she is a) of non-childbearing\r
potential, defined as pre-menopausal females with a documented tubal ligation or\r
hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b)\r
of childbearing potential but not pregnant (as determined by urinary pregnancy test on\r
screening and on each study day) and willing to use one of the contraception methods\r
listed below\r
\r
4. Male subject must agree to use one of the contraception methods listed above.\r
\r
5. Willing to abstain from alcohol for the duration of dosing.\r
\r
6. Expanded Disability Status Scale (EDSS) >3.5 <6.5 (SPMS patients only)\r
\r
Exclusion Criteria:\r
\r
1. History of active neurological disease other than migraine or MS\r
\r
2. Clinically meaningful abnormalities in routine bloods including:\r
\r
- eGFR < 60ml/min\r
\r
- Elevation of liver enzymes/bilirubin\r
\r
- Prolonged prothrombin time\r
\r
- Thrombocytopenia\r
\r
3. Use of the following medications or therapies:\r
\r
- Immunosuppressive or immunomodulatory drugs within the last 6 months\r
\r
- Alemtuzumab or haematopeotic stem cell therapy\r
\r
- Central nervous system depressants (including opioid analgesics, barbiturates,\r
sleeping pills, antihistamines, antipsychotics)\r
\r
- P450 CY3A4 inducers or inhibitors\r
\r
- oral contraceptives\r
\r
- oral anticoagulants or antiplatelet agents other than low dose aspirin\r
\r
- levothyroxine\r
\r
4. Currently breastfeeding\r
\r
5. Any clinical significant medical conditions that in the opinion of the investigator\r
would compromise subjects' safety or compliance with study procedures.\r
\r
6. History of any clinical condition which in the opinion of the principal investigator\r
would compromise the scientific integrity of the study, such as some chronic systemic\r
diseases affecting blood, liver or kidneys or endocrine system\r
\r
7. Unwillingness or inability to follow the procedures outlined in the protocol\r
\r
8. Subject is mentally or legally incapacitated\r
\r
9. Contraindication to XBD173 use:\r
\r
• Hypersensitivity to the active substance or to any of the excipients\r
\r
10. Contraindication to etifoxine use:\r
\r
- Myasthenia gravis\r
\r
- syndromes of glucose and galactose malabsorption or lactose deficiency\r
","exclusion_criteria":null,"condition":"Multiple Sclerosis","intervention":"Drug: XBD173;Drug: Etifoxine","primary_outcome":"Monocyte phenotye - Tissue necrosis factor-a;Monocyte phenotye - Interferon-?;Monocyte phenotype - Interleukins- 1ß;Monocyte phenotype - Interleukins- 16;Monocyte phenotype - Interleukins- 17;Monocyte phenotype - Interleukins- 23;Immunomodulatory factor -Transforming growth factor-ß;Immunomodulatory factor - Interleukins -4;Immunomodulatory factor - Interleukins - 10;Relative proportions of WBC subsets","secondary_outcome":"Monocyte phenotype - 'omic analyses;Neurofilament","secondary_id":"V7 03/10/18","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}]}