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

Information source: Multiple Sclerosis Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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.

Eligibility

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

Criteria:

Inclusion Criteria: Relapsing-remitting multiple sclerosis

-

Exclusion Criteria: Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease

Pregnancy -

Locations and Contacts

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
Additional Information

Starting date: April 2004
Last updated: September 14, 2005

Page last updated: August 23, 2015

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