Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis (ReBUILD)
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|ClinicalTrials.gov Identifier: NCT02040298|
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-Remitting||Drug: Clemastine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Crossover Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||April 2016|
Active Comparator: 3 months Clemastine, 2 months Placebo
4mg clemastine twice daily for first 3 months -- crossover -- equivalent quantity/frequncy of placebo for last 2 months
4mg tablet twice daily
Placebo tablet twice daily
Active Comparator: 3 months Placebo , 2 months Clemastine
Placebo for first 3 months -- crossover -- 4mg clemastine twice daily for last 2 months.
4mg tablet twice daily
Placebo tablet twice daily
- Full Field Visual Evoked Potential [ Time Frame: Baseline, 1 month, 3 month, 5 month ]The primary objective is to evaluate the efficacy of Clemastine relative to placebo for reducing P100 latencies on full field transient pattern reversal visual evoked potentials. VEPs are used primarily to measure the functional integrity of the visual pathways from the retina to the visual cortex of the brain.
- Tolerability of Clemastine in Multiple Sclerosis Patients [ Time Frame: Baseline, 1 month, 3 month, 5 month ]Will demonstrate the tolerability of Clemastine in this population. This will include special focus with regards to fatigue as this is a major symptom for patients suffering from multiple sclerosis.This will be assessed by administering a fatigue questionnaire at all four visits throughout the study.
- Myelin Water Volume and Magnetization Transfer Ratios [ Time Frame: Baseline, 3 month, 5 month time points ]
To evaluate the efficacy of Clemastine relative to placebo in increasing magnetization transfer ratios derived from magnetic resonance imaging of the brain during the period of exposure to active treatment.
To evaluate the efficacy of Clemastine relative to placebo at reducing radial diffusivity derived from diffusion tensor imaging as assessed by magnetic resonance imaging during the period of exposure to active medication.
- Expanded Disability Status Scale score [ Time Frame: Baseline, 3 months, 5 months ]
To evaluate the efficacy of Clemastine relative to placebo in reducing the EDSS score at 90 days compared to placebo (Group A) and at 150 days compared to day 90 (Group B).
The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS [ranging from 0 (normal) to 10 (death due to MS)]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner. EDSS is a widely used and accepted instrument to evaluate disability status at a given time and longitudinally, to assess disability progression in clinical studies in MS.
- Serum Creatinine Level [ Time Frame: Baseline, 1 month, 3 month, 5 month ]Blood sample will be collected at each visit to evaluate health status.
- Serum Triglyceride Level [ Time Frame: Baseline, 1 month, 3 month, 5 month ]Blood sample will be collected at each visit to evaluate health status.
- Vitamin B-12 Level [ Time Frame: Baseline, 1 month, 3 month, 5 month ]Blood sample will be collected at each visit to evaluate health status.
- Human Chorionic Gonadotropin (hCG) level in Female patients of Childbearing potential [ Time Frame: Baseline, 1 month, 3 month, 5 month ]Blood and urine sample will be collected to assess pregnancy status of all female participants of child bearing potential.
- Number of Patients with Adverse Events [ Time Frame: 1 month, 3 month, 5 month from baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040298
|United States, California|
|UCSF Multiple Sclerosis Center|
|San Francisco, California, United States, 94518|
|Principal Investigator:||Ari J. Green, MD, MCR||University of California, San Francisco|