Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00600873 |
Date of registration:
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05/01/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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R(+)PPX High Dose Treatment of ALS
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Scientific title:
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Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months |
Date of first enrolment:
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August 2007 |
Target sample size:
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10 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00600873 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Ted M Burns, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- definite ALS no prior exposure to R(+)PPX
Exclusion Criteria:
- ALSFRS at baseline <40 FVC at baseline <70%
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: R(+) pramipexole dihydrochloride monohydrate
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Primary Outcome(s)
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decline in ALSFRS score
[Time Frame: 6 months]
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Secondary Outcome(s)
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CSF PPX levels
[Time Frame: 6 months]
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plasma PPX levels
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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