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Sponsored by: |
Bennett, James P., Jr., M.D.,Ph.D. |
Information provided by: | Bennett, James P., Jr., M.D.,Ph.D. |
ClinicalTrials.gov Identifier: | NCT00600873 |
R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative stress.
Condition | Intervention | Phase |
Amyotrophic Lateral Sclerosis |
Drug: R(+) pramipexole dihydrochloride monohydrate |
Phase I Phase II |
Genetics Home Reference related topics: | amyotrophic lateral sclerosis |
MedlinePlus related topics: | Amyotrophic Lateral Sclerosis Stress |
Drug Information available for: | Pramipexol Pramipexole dihydrochloride |
Study Type: | Interventional |
Study Design: | Other, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months |
Enrollment: | 10 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
patients with early ALS
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Drug: R(+) pramipexole dihydrochloride monohydrate
100 mg tid orally daily
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Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Virginia | |||||
University of Virginia | |||||
Charlottesville, Virginia, United States, 22908 |
Bennett, James P., Jr., M.D.,Ph.D. |
Principal Investigator: | Ted M Burns, MD | University of Virginia |
Responsible Party: | University of Virginia ( James P. Bennett Jr. M.D. Ph.D. Sponsor ) |
Study ID Numbers: | 13023 |
First Received: | January 5, 2008 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00600873 |
Health Authority: | United States: Food and Drug Administration |
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