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

Phase 2

• Conditions: Multiple Sclerosis

• Registration Number: NCT00217295
• Lead Sponsor: Multiple Sclerosis Institute

Brief Summary

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.

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.

Study Timeline

• Study Start: 2004-04
• Status Verified: 2005-06
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Last Update Submitted: 2005-09-14
• Study First Posted: 2005-09-22
• Last Update Posted: 2005-09-22
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Relapsing-remitting multiple sclerosis

Exclusion Criteria

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Brain atrophy on nMRI
Disease progression on EDSS and MSFC
Relapse rate

Trial Locations

Locations (1)

Multiple Sclerosis Institute; 🇺🇸 Philadelphia, Pennsylvania, United States