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

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

September 14, 2005

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety and tolerability

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Brain atrophy on nMRI
Disease progression on EDSS and MSFC
Relapse rate

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Drug: Avonex and Topamax

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Relapsing-remitting multiple sclerosis

Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jeffrey I Greenstein, MD

215-985-2245

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00217295

Responsible Party

Study ID Numbers ^ICMJE

MSI-101, BiogenIdec, Ortho-McNeil

Study Sponsor ^ICMJE

Multiple Sclerosis Institute

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jeffrey I Greenstein, MD

MSI

Information Provided By

Multiple Sclerosis Institute

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP