The main purpose of this study is to assess clemastine as a remyelinating agent in patients with relapsing forms of multiple sclerosis. The study will also evaluate the tolerability of clemastine, originally approved as first-generation antihistamine, in patients with multiple sclerosis. Study procedures will include assessments for evidence of remyelination in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. The study will also assess the robustness and stability of this clinical effect in patients taking clemastine for up to 3 months. Patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study concurrently.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
4mg tablet twice daily
Placebo tablet twice daily
UCSF Multiple Sclerosis Center
San Francisco, California, United States
Full Field Visual Evoked Potential (VEP)
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.Visual evoked potentials (VEP) are used primarily to measure the functional integrity of the visual pathways from the retina to the visual cortex of the brain. VEP latencies were collected at Baseline, Month 1, Month 3, and Month 5.
Time frame: Treatment start to treatment end, up to 3 months.
Tolerability of Clemastine in Multiple Sclerosis (MS) Patients
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 called the Multidimensional Assessment of Fatigue (MAF) at all four visits throughout the study. MAF scale range is 0-50. Lower scores indicate lower levels of fatigue and higher scores indicate higher levels of fatigue.
Time frame: Treatment start to treatment end, up to 3 months.
Myelin Water Fraction (MWF) and Magnetization Transfer Ratios (MTR)
To evaluate the efficacy of Clemastine relative to placebo in increasing magnetization transfer ratios derived from magnetic resonance imaging (MRI) 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 (MRI) during the period of exposure to active medication.
Time frame: Treatment start to treatment end, up to 3 months.
Expanded Disability Status Scale (EDSS) Score
To evaluate the efficacy of Clemastine relative to placebo in reducing the EDSS score at 90 days compared to placebo (Group A) \& at 150 days compared to day 90 (Group B). EDSS is an ordinal scale for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) \& 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, \& Cerebral functions. FSs \& EDSS steps assessed in a standardized manner. EDSS is a widely used \&accepted instrument to evaluate disability status at a given time \& longitudinally, to assess disability progression in clinical studies in MS.
Time frame: Start of treatment to end of treatment, up to 3 months
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