R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140218
• Other study ID #: 11736
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 30, 2005
• Last updated: January 5, 2008
• Start date: August 2005
• Est. completion date: December 2006

Study information

• Verified date: January 2008
• Source: Bennett, James P., Jr., M.D., Ph.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• R(+) pramipexole dihydrochloride monohydrate
10 mg tid oral

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	David Lacomis MD	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Bennett, James P., Jr., M.D., Ph.D.	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	FVC taken each month		-3 -2 -1 0 1 2 3 4 5 6 months	No
Secondary	hand dynamometry taken each month		-3 -2 -1 0 1 2 3 4 5 6	No