A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis

Condition(s) targeted: Multiple Sclerosis

Intervention: Avonex and Topamax (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Multiple Sclerosis Institute

Official(s) and/or principal investigator(s):
Jeffrey I Greenstein, MD, Principal Investigator, Affiliation: MSI

Overall contact:
Jeffrey I Greenstein, MD, Phone: 215-985-2245

This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.

Official title: A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Safety and tolerability

Secondary outcome:

Brain atrophy on nMRI

Disease progression on EDSS and MSFC

Relapse rate

Detailed description: The protocol requires all participants to be treated with Avonex and in addition patients will be blindly assigned to either a group who receive Topamax or a placebo control. Repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. The scaled neurologic examinations (EDSS and MSFC) and brain MRI's are done at regular intervals to evaluate possible treatment effects.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

Relapsing-remitting multiple sclerosis

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Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy

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Jeffrey I Greenstein, MD, Phone: 215-985-2245

Multiple Sclerosis Institute, Philadelphia, Pennsylvania 19146, United States; Recruiting
Jeffrey I Greenstein, MD, Phone: 215-985-2245
Iris J Gold, MBA, Phone: 215-985-2245
Jeffrey I Greenstein, MD, Principal Investigator

Starting date: April 2004
Ending date: December 2007
Last updated: September 14, 2005