NCT00596115|Unknown
Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day
Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day
1 other identifier
12316
Study Type
expanded_access
Target
N/A
Locations
0 countries
Sites
N/A
Timeline
RegisteredJan 2008
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2008
Completed11 days until next milestone
First Posted
Study publicly available on registry
January 16, 2008
CompletedLast Updated
July 25, 2012
Status Verified
July 1, 2012
First QC Date
January 5, 2008
Last Update Submit
July 24, 2012
Conditions
Interventions
20 mg tid per day orally
Eligibility Criteria
Age30 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
- Definite diagnosis of ALS
You may not qualify if:
- No prior participation in R(+)PPX clinical studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bennett, James P., Jr., M.D., Ph.D.lead
- University of Pittsburghcollaborator
- University of Nebraskacollaborator
MeSH Terms
Conditions
Amyotrophic Lateral Sclerosis
Condition Hierarchy (Ancestors)
Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2008
First Posted
January 16, 2008
Last Updated
July 25, 2012
Record last verified: 2012-07