Trial Outcomes & Findings for Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis (NCT NCT02040298)

NCT ID: NCT02040298

Last Updated: 2025-09-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Treatment start to treatment end, up to 3 months.

Results posted on

2025-09-17

Participant Flow

Participant milestones

Participant milestones
Measure	Clemastine First, Then Placebo Participants first received Clemastine 4mg twice daily for 3 months. Then they received Placebo (matching Clemastine 4mg) twice daily for 2 months.	Placebo First, Then Clemastine Participants first received Placebo (matching Clemastine 4mg) twice daily for 3 months. Then they received Clemastine 4mg twice daily for 2 months.
First Intervention (3 Months) STARTED	25	25
First Intervention (3 Months) COMPLETED	25	25
First Intervention (3 Months) NOT COMPLETED	0	0
Second Intervention (2 Months) STARTED	25	25
Second Intervention (2 Months) COMPLETED	25	25
Second Intervention (2 Months) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clemastine First, Then Placebo n=25 Participants Participants first received Clemastine 4mg tablet twice daily for 3 months, then they received Placebo (matching Clemastine 4mg) for 2 months.	Placebo First, Then Clemastine n=25 Participants Participants first received Placebo (matching Clemastine 4mg) tablet twice daily for 3 months, then they received Clemastine 4mg twice daily for 2 months.	Total n=50 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 10.8 • n=93 Participants	40.0 years STANDARD_DEVIATION 10.1 • n=4 Participants	40.1 years STANDARD_DEVIATION 10.2 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	13 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	12 Participants n=4 Participants	18 Participants n=27 Participants
Disease duration	5.7 years STANDARD_DEVIATION 6.5 • n=93 Participants	4.4 years STANDARD_DEVIATION 3.6 • n=4 Participants	5.1 years STANDARD_DEVIATION 5.2 • n=27 Participants
EDSS	2.2 units on a scale STANDARD_DEVIATION 1.0 • n=93 Participants	2.1 units on a scale STANDARD_DEVIATION 1.2 • n=4 Participants	2.2 units on a scale STANDARD_DEVIATION 1.1 • n=27 Participants
History of optic neuritis	15 Participants n=93 Participants	13 Participants n=4 Participants	28 Participants n=27 Participants
Time since optic neuritis	3.7 years STANDARD_DEVIATION 3.4 • n=93 Participants	4.9 years STANDARD_DEVIATION 4.6 • n=4 Participants	4.3 years STANDARD_DEVIATION 4.0 • n=27 Participants
VEP P100 latency	128.6 milliseconds STANDARD_DEVIATION 11.6 • n=93 Participants	126.8 milliseconds STANDARD_DEVIATION 9.4 • n=4 Participants	127.7 milliseconds STANDARD_DEVIATION 10.5 • n=27 Participants
OCT Retinal Nerve Fiber Layer (RNFL)	90.2 µm STANDARD_DEVIATION 12.0 • n=93 Participants	85.1 µm STANDARD_DEVIATION 7.9 • n=4 Participants	86.7 µm STANDARD_DEVIATION 10.4 • n=27 Participants
OCT Macular volume	3.05 mm^3 STANDARD_DEVIATION 0.14 • n=93 Participants	3.01 mm^3 STANDARD_DEVIATION 0.11 • n=4 Participants	3.03 mm^3 STANDARD_DEVIATION 0.13 • n=27 Participants
LCLA	24.0 Number of letters read correctly STANDARD_DEVIATION 8.4 • n=93 Participants	21.6 Number of letters read correctly STANDARD_DEVIATION 10.7 • n=4 Participants	22.8 Number of letters read correctly STANDARD_DEVIATION 9.6 • n=27 Participants
SDMT	51.8 number of correct substitutions STANDARD_DEVIATION 10.2 • n=93 Participants	50.0 number of correct substitutions STANDARD_DEVIATION 11.1 • n=4 Participants	50.9 number of correct substitutions STANDARD_DEVIATION 10.6 • n=27 Participants
MAF	17.82 units on a scale STANDARD_DEVIATION 12.39 • n=93 Participants	20.43 units on a scale STANDARD_DEVIATION 10.88 • n=4 Participants	19.13 units on a scale STANDARD_DEVIATION 11.62 • n=27 Participants
6-min walk	1742.40 feet STANDARD_DEVIATION 288.14 • n=93 Participants	1741.76 feet STANDARD_DEVIATION 260.08 • n=4 Participants	1742.08 feet STANDARD_DEVIATION 271.66 • n=27 Participants
25-foot walk	3.81 seconds STANDARD_DEVIATION 0.67 • n=93 Participants	4.10 seconds STANDARD_DEVIATION 1.01 • n=4 Participants	3.96 seconds STANDARD_DEVIATION 0.86 • n=27 Participants
Myelin water fraction	67.55 ratio STANDARD_DEVIATION 11.85 • n=93 Participants	65.70 ratio STANDARD_DEVIATION 12.98 • n=4 Participants	66.62 ratio STANDARD_DEVIATION 12.33 • n=27 Participants
MTR 25 Brain	0.39 ratio STANDARD_DEVIATION 0.05 • n=93 Participants	0.38 ratio STANDARD_DEVIATION 0.03 • n=4 Participants	0.39 ratio STANDARD_DEVIATION 0.04 • n=27 Participants
MTR 25 White matter	0.54 ratio STANDARD_DEVIATION 0.02 • n=93 Participants	0.54 ratio STANDARD_DEVIATION 0.02 • n=4 Participants	0.54 ratio STANDARD_DEVIATION 0.02 • n=27 Participants
FA white matter	0.24 ratio STANDARD_DEVIATION 0.02 • n=93 Participants	0.24 ratio STANDARD_DEVIATION 0.01 • n=4 Participants	0.24 ratio STANDARD_DEVIATION 0.01 • n=27 Participants

PRIMARY outcome

Timeframe: Treatment start to treatment end, up to 3 months.

Population: The data for 7 eyes did not meet criteria for inclusion in analysis (i.e., absent or unidentifiable waveforms.).

Outcome measures

Outcome measures
Measure	Clemastine n=93 eyes Participants who received clemastine 4mg twice daily in either the first 3 months or the last 2 months of the study	Placebo n=93 eyes Participants who received Placebo tablet (matching clemastine 4mg) twice daily in either the first 3 months or last 2 months of the study.
Full Field Visual Evoked Potential (VEP) VEP at baseline	124.8 ms Standard Deviation 11.5	126.4 ms Standard Deviation 10.9
Full Field Visual Evoked Potential (VEP) VEP change from baseline	-2.86 ms Standard Deviation 6.85	-1.50 ms Standard Deviation 3.86

SECONDARY outcome

Timeframe: Treatment start to treatment end, up to 3 months.

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.

Outcome measures

Outcome measures
Measure	Clemastine n=50 Participants Participants who received clemastine 4mg twice daily in either the first 3 months or the last 2 months of the study	Placebo n=50 Participants Participants who received Placebo tablet (matching clemastine 4mg) twice daily in either the first 3 months or last 2 months of the study.
Tolerability of Clemastine in Multiple Sclerosis (MS) Patients MAF at baseline	21.0 score on a scale Standard Deviation 10.9	18.8 score on a scale Standard Deviation 12.2
Tolerability of Clemastine in Multiple Sclerosis (MS) Patients MAF change from baseline	1.9 score on a scale Standard Deviation 6.8	-0.4 score on a scale Standard Deviation 6.9

SECONDARY outcome

Timeframe: Treatment start to treatment end, up to 3 months.

Population: MRI done at baseline, month 3, month 5

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.

Outcome measures

Outcome measures
Measure	Clemastine n=50 Participants Participants who received clemastine 4mg twice daily in either the first 3 months or the last 2 months of the study	Placebo n=50 Participants Participants who received Placebo tablet (matching clemastine 4mg) twice daily in either the first 3 months or last 2 months of the study.
Myelin Water Fraction (MWF) and Magnetization Transfer Ratios (MTR) MTR 25: full brain at baseline	0,380 Ratio Standard Deviation 0.040	0.379 Ratio Standard Deviation 0.041
Myelin Water Fraction (MWF) and Magnetization Transfer Ratios (MTR) MTR: white matter at baseline	0.533 Ratio Standard Deviation 0.018	0.533 Ratio Standard Deviation 0.021
Myelin Water Fraction (MWF) and Magnetization Transfer Ratios (MTR) MWF 50 at baseline	66.38 Ratio Standard Deviation 13.06	66.12 Ratio Standard Deviation 12.69
Myelin Water Fraction (MWF) and Magnetization Transfer Ratios (MTR) MTR 25: full brain change from baseline	-0.008 Ratio Standard Deviation 0.016	-0.009 Ratio Standard Deviation 0.018
Myelin Water Fraction (MWF) and Magnetization Transfer Ratios (MTR) MTR: white matter change from baseline	-0.004 Ratio Standard Deviation 0.021	-0.004 Ratio Standard Deviation 0.018
Myelin Water Fraction (MWF) and Magnetization Transfer Ratios (MTR) MWF 50 change from baseline	0.23 Ratio Standard Deviation 13.20	-0.55 Ratio Standard Deviation 10.78

SECONDARY outcome

Timeframe: Start of treatment to end of treatment, up to 3 months

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.

Outcome measures

Outcome measures
Measure	Clemastine n=50 Participants Participants who received clemastine 4mg twice daily in either the first 3 months or the last 2 months of the study	Placebo n=50 Participants Participants who received Placebo tablet (matching clemastine 4mg) twice daily in either the first 3 months or last 2 months of the study.
Expanded Disability Status Scale (EDSS) Score EDSS at baseline	2.06 score on a scale Standard Deviation 1.21	2.14 score on a scale Standard Deviation 1.15
Expanded Disability Status Scale (EDSS) Score EDSS change from baseline	-0.09 score on a scale Standard Deviation 0.87	-0.03 score on a scale Standard Deviation 0.69

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 month, 3 month, 5 month

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Clemastine n=50 participants at risk Participants received Clemastine 4mg twice daily for either 3 months or 2 months.	Placebo n=50 participants at risk Participants received Placebo (matching Clemastine 4mg) for either 3 months or 2 months.
Investigations Increased trigylcerides	20.0% 10/50 • Through study completion, an average of 5 months.	28.0% 14/50 • Through study completion, an average of 5 months.
Investigations Severe fatigue	0.00% 0/50 • Through study completion, an average of 5 months.	2.0% 1/50 • Through study completion, an average of 5 months.

Additional Information

Tracy Tran, BA

UCSF

Phone: 415-353-2707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place