A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/2/2016 |
| Start Date: | April 2004 |
| End Date: | December 2007 |
| Contact: | Jeffrey I Greenstein, MD |
| Phone: | 215-985-2245 |
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.
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.
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.
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.
Inclusion Criteria:
Relapsing-remitting multiple sclerosis
Exclusion Criteria:
Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease
Pregnancy -
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