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

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.
 
ClinicalTrials.gov Identifier: NCT00217295
Recruitment Status : Unknown
Verified June 2005 by Multiple Sclerosis Institute.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Information provided by:
Multiple Sclerosis Institute

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Avonex and Topamax Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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.
Study Start Date : April 2004
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Safety and tolerability

Secondary Outcome Measures :
  1. Brain atrophy on nMRI
  2. Disease progression on EDSS and MSFC
  3. Relapse rate


Information from the National Library of Medicine

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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 -


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
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Contact: Jeffrey I Greenstein, MD 215-985-2245

Locations
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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
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Principal Investigator: Jeffrey I Greenstein, MD MSI
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ClinicalTrials.gov Identifier: NCT00217295    
Other Study ID Numbers: MSI-101
BiogenIdec
Ortho-McNeil
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: June 2005
Keywords provided by Multiple Sclerosis Institute:
Relapsing-remitting multiple sclerosis
Brain atrophy
Disease progression
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs