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

This study is currently recruiting participants.

Verified by Multiple Sclerosis Institute, June 2005

First Received: September 14, 2005 No Changes Posted

Sponsored by:	Multiple Sclerosis Institute
Information provided by:	Multiple Sclerosis Institute
ClinicalTrials.gov Identifier:	NCT00217295

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Avonex and Topamax	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Topiramate Interferon beta 1a

U.S. FDA Resources

Further study details as provided by Multiple Sclerosis Institute:

Primary Outcome Measures:

Safety and tolerability

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	April 2004
Estimated Study Completion Date:	December 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Relapsing-remitting multiple sclerosis

Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217295

Contacts

Contact: Jeffrey I Greenstein, MD

215-985-2245

Locations

United States, Pennsylvania
Multiple Sclerosis Institute	Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Jeffrey I Greenstein, MD 215-985-2245
Contact: Iris J Gold, MBA 215-985-2245
Principal Investigator: Jeffrey I Greenstein, MD

Sponsors and Collaborators

Multiple Sclerosis Institute

Investigators

Principal Investigator:

Jeffrey I Greenstein, MD

MSI

More Information

No publications provided

Study ID Numbers:	MSI-101, BiogenIdec, Ortho-McNeil
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00217295 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Multiple Sclerosis Institute:

Relapsing-remitting multiple sclerosis
Brain atrophy
Disease progression

Study placed in the following topic categories:

Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Interferons
Adjuvants, Immunologic
Disease Progression
Interferon-beta
Sclerosis
Neuroprotective Agents

Multiple Sclerosis, Relapsing-Remitting
Anti-Obesity Agents
Multiple Sclerosis
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Topiramate
Atrophy
Anticonvulsants
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Sclerosis
Protective Agents
Neuroprotective Agents
Multiple Sclerosis, Relapsing-Remitting

Pharmacologic Actions
Anti-Obesity Agents
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Topiramate
Central Nervous System Agents
Autoimmune Diseases of the Nervous System
Anticonvulsants

ClinicalTrials.gov processed this record on July 02, 2009