A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis
Recruitment status was Recruiting
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis. |
- Safety and tolerability
- 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 |
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 |
Inclusion Criteria:
Relapsing-remitting multiple sclerosis
-
Exclusion Criteria:
Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -
Contacts and Locations| Contact: Jeffrey I Greenstein, MD | 215-985-2245 |
| 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 | |
| Principal Investigator: | Jeffrey I Greenstein, MD | MSI |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00217295 History of Changes |
| Other Study ID Numbers: | MSI-101, BiogenIdec, Ortho-McNeil |
| Study First Received: | September 14, 2005 |
| Last Updated: | September 14, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Multiple Sclerosis Institute:
|
Relapsing-remitting multiple sclerosis Brain atrophy Disease progression |
Additional relevant MeSH terms:
|
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Topiramate Interferon beta 1a |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents Adjuvants, Immunologic Immunologic Factors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013