Back to resultsR(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
R(+) pramipexole dihydrochloride monohydrate
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring amyotrophic lateral sclerosis, pramipexole, oxidative stress, neuroprotection
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
Sites / Locations
- David Lacomis MD
- University of Virginia
Outcomes
Primary Outcome Measures
ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment
Secondary Outcome Measures
FVC taken each month
hand dynamometry taken each month
Full Information
NCT ID
NCT00140218
First Posted
August 30, 2005
Last Updated
January 5, 2008
Sponsor
Bennett, James P., Jr., M.D., Ph.D.
Collaborators
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00140218
Brief Title
R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Official Title
Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bennett, James P., Jr., M.D., Ph.D.
Collaborators
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
amyotrophic lateral sclerosis, pramipexole, oxidative stress, neuroprotection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
R(+) pramipexole dihydrochloride monohydrate
Intervention Description
10 mg tid oral
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
FVC taken each month
Time Frame
-3 -2 -1 0 1 2 3 4 5 6 months
Title
hand dynamometry taken each month
Time Frame
-3 -2 -1 0 1 2 3 4 5 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence H Phillips, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Lacomis MD
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
We'll reach out to this number within 24 hrs