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

NCT ID: NCT00217295

Last Updated: 2005-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Keywords

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Relapsing-remitting multiple sclerosis Brain atrophy Disease progression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Avonex and Topamax

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Relapsing-remitting multiple sclerosis

\-

Exclusion Criteria

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Multiple Sclerosis Institute

OTHER

Sponsor Role lead

Principal Investigators

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Jeffrey I Greenstein, MD

Role: PRINCIPAL_INVESTIGATOR

MSI

Locations

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Multiple Sclerosis Institute

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeffrey I Greenstein, MD

Role: CONTACT

Phone: 215-985-2245

Facility Contacts

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Jeffrey I Greenstein, MD

Role: primary

Iris J Gold, MBA

Role: backup

Other Identifiers

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BiogenIdec

Identifier Type: -

Identifier Source: secondary_id

Ortho-McNeil

Identifier Type: -

Identifier Source: secondary_id

MSI-101

Identifier Type: -

Identifier Source: org_study_id