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

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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

September 14, 2005
September 22, 2005
September 22, 2005
April 2004
Not Provided
Safety and tolerability
Same as current
No Changes Posted
  • Brain atrophy on nMRI
  • Disease progression on EDSS and MSFC
  • Relapse rate
Same as current
Not Provided
Not Provided
 
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Multiple Sclerosis
Drug: Avonex and Topamax
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
December 2007
Not Provided

Inclusion Criteria:

Relapsing-remitting multiple sclerosis

Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00217295
MSI-101
BiogenIdec
Ortho-McNeil
Not Provided
Not Provided
Not Provided
Not Provided
Multiple Sclerosis Institute
Not Provided
Principal Investigator: Jeffrey I Greenstein, MD MSI
Multiple Sclerosis Institute
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP