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

M

Multiple Sclerosis Institute

Status and phase

Unknown
Phase 2

Conditions

Multiple Sclerosis

Treatments

Drug: Avonex and Topamax

Study type

Interventional

Funder types

Other

Identifiers

NCT00217295
Ortho-McNeil
MSI-101
BiogenIdec

Details and patient eligibility

About

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.

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.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Relapsing-remitting multiple sclerosis

Exclusion criteria

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Jeffrey I Greenstein, MD

Data sourced from clinicaltrials.gov

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