R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

Completed · Phase 1/Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT00140218

Run by

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

People needed

30

Starts

2005-08-01

Expected to finish

2006-12-01

Last updated by the study team

2008-01-08

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• David Lacomis MD — Pittsburgh, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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