R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

Bennett, James P., Jr., M.D., Ph.D.

Status and phase

Completed

Phase 2

Phase 1

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: R(+) pramipexole dihydrochloride monohydrate

Study type

Interventional

Funder types

Other

Identifiers

NCT00140218

11736 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 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%.

Enrollment

30 patients

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

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