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 because the information has not been verified recently.
Verified June 2005 by Multiple Sclerosis Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Multiple Sclerosis Institute
ClinicalTrials.gov Identifier:
NCT00217295
First received: September 14, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  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.

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

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
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, see Learn About Clinical Studies.

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

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
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 August 26, 2014