Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis

Inclusion Criteria:

- Relapsing remitting Multiple Sclerosis by 2010 Revised McDonald Criteria

- Age 18-60.

- Latency delay > 125 milliseconds on baseline full-field transient pattern reversal
VEP in at least one eye (electrophysiological evidence of demyelination)

- RNFL > 70 microns on SD-OCT in the same eye meeting criteria for latency delay
(sufficient axons)

- No optic neuritis in prior 6 months

- Stable immunomodulatory therapy - no switch or planned switch in > 6 months and no
change in doses in 30 days prior to screening

- Use of appropriate contraception during period of trial (females of child bearing
potential)

- Understand and sign informed consent.

- EDSS 0-6.0 (inclusive)

Exclusion Criteria:

- Major ophthalmologic disease / Concomitant ophthalmologic disorders (e.g. diabetes,
macular degeneration, glaucoma, severe myopia , etc).

- Myopia > -7 Diopters (Severe myopia)

- History of significant cardiac conduction block

- History of cancer

- Known optic neuritis in involved eye > 5 years ago OR disease duration > 15 years

- Suicidal ideation or behaviour in 6 months prior to screening

- Pregnancy, breastfeeding, or planning to become pregnant.

- Involved with other study protocol simultaneously without prior approval. 9.
Concomitant use of Dalfamprdine or any other formulation of 4AP or diamino4AP.

- Concomitant use of any other putative remyelinating therapy as determined by
investigator.

- Treatment with corticosteroids within 30 days prior to screening

- Prior treatment with total lymphoid irradiation, T cell or T cell receptor
vaccination

- Prior treatment with alemtuzamab, mitoxantrone, or cyclophosphamide

- Serum creatinine > 1.5 mg/dL; AST, ALT or alkaline phosphatase > 2 times the upper
limit of normal

- History of drug or alcohol abuse within the past year

- Untreated B12 deficiency (as determined by B12 serological assessments and
metabolites including methylmalonic acid [MMA] and homocysteine) or untreated
hypothyroidism

- Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic,
urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic,
psychiatric allergic, renal or other major diseases that in the PI's judgment may
affect interpretation of study results or patient safety.

- History of or presence of clinically significant medical illness or laboratory
abnormality that, in the opinion of the investigator would preclude participation in
the study