R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

• ClinicalTrials.gov Identifier: NCT00140218
• Recruitment Status: Completed
• First Posted: September 1, 2005
• Last Update Posted: January 8, 2008
• Sponsor: Bennett, James P., Jr., M.D., Ph.D.
• Collaborator: University of Pittsburgh
• Information provided by: Bennett, James P., Jr., M.D., Ph.D.

Tracking Information

• First Submitted Date: August 30, 2005
• First Posted Date: September 1, 2005
• Last Update Posted Date: January 8, 2008
• Study Start Date: August 2005
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 5, 2008): 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 ]
• Original Primary Outcome Measures (submitted: August 30, 2005): ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment

Current Secondary Outcome Measures (submitted: January 5, 2008)

• 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 ]

Original Secondary Outcome Measures (submitted: August 30, 2005)

• FVC taken each month
• hand dynamometry taken each month

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
• Official Title: Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Amyotrophic Lateral Sclerosis

Intervention

Drug: R(+) pramipexole dihydrochloride monohydrate

10 mg tid oral

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 5, 2008): 30
• Original Enrollment (submitted: August 30, 2005): 20
• Actual Study Completion Date: December 2006
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00140218
• Other Study ID Numbers: 11736
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: James P. Bennett Jr. M.D. Ph.D. Sponsor, University of Virginia
• Original Responsible Party: Not Provided
• Current Study Sponsor: Bennett, James P., Jr., M.D., Ph.D.
• Original Study Sponsor: Same as current
• Collaborators: University of Pittsburgh

Investigators

• Principal Investigator: Lawrence H Phillips, M.D.; University of Virginia

• PRS Account: Bennett, James P., Jr., M.D., Ph.D.
• Verification Date: January 2008