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.
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%.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
10 mg tid oral
David Lacomis MD
Pittsburgh, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment
Time frame: -3 -2 -1 0 1 2 3 4 5 6 months
FVC taken each month
Time frame: -3 -2 -1 0 1 2 3 4 5 6 months
hand dynamometry taken each month
Time frame: -3 -2 -1 0 1 2 3 4 5 6
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