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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00217295

Enrollment

Registered

2005-09-22

Start date

2004-04-30

Completion date

2007-12-31

Last updated

2005-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Relapsing-remitting multiple sclerosis, Brain atrophy, Disease progression

Brief 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.

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.

Interventions

DRUGAvonex and Topamax

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

Relapsing-remitting multiple sclerosis \-

Exclusion criteria

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	—

Secondary

Measure	Time frame
Brain atrophy on nMRI	—
Disease progression on EDSS and MSFC	—
Relapse rate	—

Countries

United States

Contacts

Primary ContactJeffrey I Greenstein, MD

215-985-2245

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026