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Sponsors and Collaborators: |
Bennett, James P., Jr., M.D.,Ph.D. University of Pittsburgh |
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Information provided by: | Bennett, James P., Jr., M.D.,Ph.D. |
ClinicalTrials.gov Identifier: | NCT00140218 |
The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.
Condition | Intervention | Phase |
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Amyotrophic Lateral Sclerosis |
Drug: R(+) pramipexole dihydrochloride monohydrate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis |
Enrollment: | 30 |
Study Start Date: | August 2005 |
Study Completion Date: | December 2006 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40%.
Ages Eligible for Study: | 21 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
David Lacomis MD | |
Pittsburgh, Pennsylvania, United States | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | Lawrence H Phillips, M.D. | University of Virginia |
Responsible Party: | University of Virginia ( James P. Bennett Jr. M.D. Ph.D. Sponsor ) |
Study ID Numbers: | 11736 |
Study First Received: | August 30, 2005 |
Last Updated: | January 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00140218 |
Health Authority: | United States: Food and Drug Administration |
amyotrophic lateral sclerosis pramipexole oxidative stress neuroprotection |
Spinal Cord Diseases Stress Central Nervous System Diseases Sclerosis Degenerative motor system disease Neurodegenerative Diseases Motor neuron disease |
Pramipexol Dopamine Amyotrophic lateral sclerosis Neuromuscular Diseases Amyotrophic Lateral Sclerosis Lou Gehrig's disease Motor Neuron Disease |
Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents |
Dopamine Agonists Protective Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Central Nervous System Agents |