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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00217295
• Other study ID #: MSI-101
• Secondary ID: BiogenIdecOrtho-
• Status: Recruiting
• Phase: Phase 2
• First received: September 14, 2005
• Last updated: September 14, 2005
• Start date: April 2004
• Est. completion date: December 2007

Study information

• Verified date: June 2005
• Source: Multiple Sclerosis Institute
• Contact: Jeffrey I Greenstein, MD
• Phone: 215-985-2245
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

Relapsing-remitting multiple sclerosis

Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Avonex and Topamax

Locations

Country	Name	City	State
United States	Multiple Sclerosis Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Multiple Sclerosis Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability
Secondary	Brain atrophy on nMRI
Secondary	Disease progression on EDSS and MSFC
Secondary	Relapse rate