Trial | NCT00140218  Report issue

Title

R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pramipexole ...

  • Study Participants

    30
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 Started
Aug 31
2005
Primary Completion
Jan 31
2007
Study Completion
Dec 31
2006
Last Update
Jan 08
2008
Estimate

Drug R(+) pramipexole dihydrochloride monohydrate

10 mg tid oral

Criteria 

Inclusion Criteria:

established diagnosis of ALS FVC>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices)

Exclusion Criteria:

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
No Results Posted