Trial | NCT00217295  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
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 Started
Apr 30
2004
Study Completion
Dec 31
2007
Last Update
Sep 22
2005
Estimate

Drug Avonex and Topamax

Criteria 

Inclusion Criteria:

Relapsing-remitting multiple sclerosis

-

Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -
No Results Posted