Multiple Sclerosis Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Relapsing-remitting multiple sclerosis

-

Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00217295

Recruitment Status:

Unknown status

Sponsor:

Multiple Sclerosis Institute

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There is 1 Location for this study

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Multiple Sclerosis Institute
Philadelphia Pennsylvania, 19146, United States More Info
Jeffrey I Greenstein, MD
Contact
215-985-2245
Iris J Gold, MBA
Contact
215-985-2245
Jeffrey I Greenstein, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00217295

Recruitment Status:

Unknown status

Sponsor:


Multiple Sclerosis Institute

How clear is this clinincal trial information?

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