R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT00140218
• Lead Sponsor: Bennett, James P., Jr., M.D., Ph.D.

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 stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.

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 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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Study Completion: 2006-12
• Primary Completion: 2007-01
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-05
• Last Update Posted: 2008-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment	-3 -2 -1 0 1 2 3 4 5 6 months

Secondary Outcome Measures

Name	Time	Method
FVC taken each month	-3 -2 -1 0 1 2 3 4 5 6 months
hand dynamometry taken each month	-3 -2 -1 0 1 2 3 4 5 6

Trial Locations

Locations (2)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

David Lacomis MD; 🇺🇸 Pittsburgh, Pennsylvania, United States