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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by Multiple Sclerosis Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00217295
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Multiple Sclerosis Institute
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00217295     History of Changes
Other Study ID Numbers: MSI-101
BiogenIdec
Ortho-McNeil
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: June 2005

Keywords provided by Multiple Sclerosis Institute:
Relapsing-remitting multiple sclerosis
Brain atrophy
Disease progression

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Topiramate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents