Status:
COMPLETED
Pilot Test of ACTOS in Multiple Sclerosis: Safety and Tolerability
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether an already FDA approved drug is safe and tolerable in Relapsing Remitting Multiple Sclerosis patients.
Detailed Description
1. Current treatments for Multiple Sclerosis (MS) only partially reduce the relapse rate or improve symptoms, have to be injected, and have side effects. In animal models of MS, the FDA-approved oral ...
Eligibility Criteria
Inclusion
- Informed consent must be signed and dated Clinically or laboratory definite RR MS Mild symptoms, with current EDSS between 1 and 6.5, and ambulatory Currently taking, and history (\>= 1 year) of taking Avonex or Rebif No relapses in past 3 months Historical annual relapse rate of \>=1.0 for the past 2 years Male or female, age 18 to 65 No history of liver disease, hypoglycemia, or cardiac related diseases Ability to carry out requirements for participation Not meeting any exclusion criteria
Exclusion
- Not meeting all inclusion criteria If female, pregnant, or intent to become pregnant or breast feed during trial Unable to give written consent Unable to carry out requirements of trial History of other neurological disease History of cardiovascular disease History of liver disease History of hypoglycemia History of high blood pressure HIV positive Exacerbation within 90 days of enrollment Intolerance to MRI
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00242177
Start Date
October 1 2003
End Date
October 1 2005
Last Update
July 22 2019
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612