Status:
COMPLETED
R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Lead Sponsor:
Bennett, James P., Jr., M.D., Ph.D.
Collaborating Sponsors:
University of Pittsburgh
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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 s...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- established diagnosis of ALS FVC\>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices)
Exclusion
- ALS duration \>3 years advanced ALS with survival predicted \<6 months dementia (MMSE\<22) prior exposure to R(+) pramipexole orthostatic hypotension \>30 mmHg history of psychosis or hallucinations abnormal baseline safety lab values
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00140218
Start Date
August 1 2005
End Date
December 1 2006
Last Update
January 8 2008
Active Locations (2)
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1
David Lacomis MD
Pittsburgh, Pennsylvania, United States
2
University of Virginia
Charlottesville, Virginia, United States, 22908