Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
Pilot Test of ACTOS in Multiple Sclerosis: Safety and Tolerability
NCT number | NCT00242177 |
Other study ID # | 2003-0547 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | October 2003 |
Est. completion date | October 2005 |
Verified date | July 2019 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether an already FDA approved drug is safe and tolerable in Relapsing Remitting Multiple Sclerosis patients.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 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 Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | Takeda Pharmaceuticals North America, Inc. |
United States,
Feinstein DL, Galea E, Gavrilyuk V, Brosnan CF, Whitacre CC, Dumitrescu-Ozimek L, Landreth GE, Pershadsingh HA, Weinberg G, Heneka MT. Peroxisome proliferator-activated receptor-gamma agonists prevent experimental autoimmune encephalomyelitis. Ann Neurol. 2002 Jun;51(6):694-702. — View Citation
Pershadsingh HA, Heneka MT, Saini R, Amin NM, Broeske DJ, Feinstein DL. Effect of pioglitazone treatment in a patient with secondary multiple sclerosis. J Neuroinflammation. 2004 Apr 20;1(1):3. — View Citation
Schmidt S, Moric E, Schmidt M, Sastre M, Feinstein DL, Heneka MT. Anti-inflammatory and antiproliferative actions of PPAR-gamma agonists on T lymphocytes derived from MS patients. J Leukoc Biol. 2004 Mar;75(3):478-85. Epub 2003 Dec 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI with GD enhancement at visit 2, 5, 8 | |||
Primary | Blood test (CBC, Liver enzymes)at each visit | |||
Primary | EDSS at each visit | |||
Primary | MSFC at each visit |
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