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| Sponsor: | University of Rochester |
|---|---|
| Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Michael J. Fox Foundation for Parkinson's Research |
| Information provided by (Responsible Party): | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01280123 |
Purpose
This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility.
Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no more than 8 months, will be randomized to one of two dosages of oral pioglitazone (15 mg and 45 mg) or matching placebo.
The study will measure disease progression by the change in total UPDRS score between the baseline visit and 44 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Pioglitazone Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's Disease |
| Estimated Enrollment: | 216 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 15 mg pioglitazone
15 mg pioglitazone
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Drug: Pioglitazone
Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo 44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks. Other Names:
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Experimental: 45 mg pioglitazone
45 mg pioglitazone
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Drug: Pioglitazone
Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo 44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks. Other Names:
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Placebo Comparator: Matching Placebo
Placebo
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Drug: placebo
Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule.
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Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 42 Study Locations| Study Director: | Tanya Simuni, MD | Northwestern University |
| Study Director: | Karl Kieburtz, MD MPH | University of Rochester |
More Information
| Responsible Party: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01280123 History of Changes |
| Other Study ID Numbers: | FS-ZONE |
| Study First Received: | December 3, 2010 |
| Last Updated: | November 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Parkinson's Disease Biomarkers |
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Movement Disorders Neurodegenerative Diseases Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |