Back to results

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

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Avonex and Topamax

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Relapsing-remitting multiple sclerosis, Brain atrophy, Disease progression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Relapsing-remitting multiple sclerosis - Exclusion Criteria: Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Sites / Locations

Multiple Sclerosis InstituteRecruiting

Outcomes

Primary Outcome Measures

Safety and tolerability

Secondary Outcome Measures

Brain atrophy on nMRI

Disease progression on EDSS and MSFC

Relapse rate

Full Information

NCT ID

NCT00217295

First Posted

September 14, 2005

Last Updated

September 14, 2005

Sponsor

Multiple Sclerosis Institute

1. Study Identification

Unique Protocol Identification Number

NCT00217295

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2005

Overall Recruitment Status

Unknown status

Study Start Date

April 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Multiple Sclerosis Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Relapsing-remitting multiple sclerosis, Brain atrophy, Disease progression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Avonex and Topamax

Primary Outcome Measure Information:

Title

Safety and tolerability

Secondary Outcome Measure Information:

Title

Brain atrophy on nMRI

Title

Disease progression on EDSS and MSFC

Title

Relapse rate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Relapsing-remitting multiple sclerosis - Exclusion Criteria: Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffrey I Greenstein, MD

Phone

215-985-2245

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey I Greenstein, MD

Organizational Affiliation

MSI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Multiple Sclerosis Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19146

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeffrey I Greenstein, MD

Phone

215-985-2245

First Name & Middle Initial & Last Name & Degree

Iris J Gold, MBA

Phone

215-985-2245

First Name & Middle Initial & Last Name & Degree

Jeffrey I Greenstein, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs