Back to resultsTreating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Temporarily not available
Phase
Locations
Study Type
Expanded Access
Intervention
R(+) pramipexole dihydrochloride monohydrate
Sponsored by
About this trial
This is an expanded access trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Definite diagnosis of ALS
Exclusion Criteria:
- No prior participation in R(+)PPX clinical studies
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00596115
First Posted
January 5, 2008
Last Updated
July 24, 2012
Sponsor
Bennett, James P., Jr., M.D., Ph.D.
Collaborators
University of Pittsburgh, University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT00596115
Brief Title
Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day
Official Title
Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Temporarily not available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bennett, James P., Jr., M.D., Ph.D.
Collaborators
University of Pittsburgh, University of Nebraska
4. Oversight
5. Study Description
Brief Summary
R(+) pramipexole dihydrochloride monohydrate [R(+)PPX], an experimental neuroprotective drug, is provided in this open label extension study to ALS patients who have participated in earlier clinical protocols.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
R(+) pramipexole dihydrochloride monohydrate
Intervention Description
20 mg tid per day orally
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Definite diagnosis of ALS
Exclusion Criteria:
No prior participation in R(+)PPX clinical studies
12. IPD Sharing Statement
Learn more about this trial
Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day
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