Not Signed In -
Amyotrophic Lateral Sclerosis |
Als; Amyotrophic Lateral Sclerosis (ALS); Amyotrophic lateral sclerosis, type 2; Amyotrophic lateral sclerosis, type 4; Amyotrophic Lateral Sclerosis/als; autosomal dominant juvenile ALS; autosomal recessive form of juvenile ALS type 3; Charcot disease; dHMN; FALS; familial amyotrophic lateral sclerosis; juvenile amyotrophic lateral sclerosis; Lou Gehrig Disease; Lou Gehrig's Disease; Lou Gehrig//'s disease; Motor Neuron Disease, Amyotrophic Lateral Sclerosis; neuronopathy, distal hereditary motor, with pyramidal features; RFALS type 3 |
Clinical Trial: R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
This study is currently recruiting patients.
Verified by Bennett, James P., Jr., M.D.,Ph.D. August 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Amyotrophic Lateral Sclerosis | Drug: R(+) pramipexole dihydrochloride monohydrate | Phase II |
MedlinePlus related topics: Amyotrophic Lateral Sclerosis
Genetics Home Reference related topics: amyotrophic lateral sclerosis
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Further Study Details:
Primary Outcomes: ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment
Secondary Outcomes: FVC taken each month; hand dynamometry taken each month
Expected Total Enrollment: 20
Secondary Outcomes: FVC taken each month; hand dynamometry taken each month
Expected Total Enrollment: 20
Study start: August 2005; Expected completion: August 2006
Last follow-up: July 2006; Data entry closure: July 2006
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%.
Eligibility
Ages Eligible for Study: 21 Years - 85 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00140218
Lawrence H Phillips, M.D. 434-924-5361 lhp3n@virginia.edu
Virginia
University of Virginia, Charlottesville, Virginia, 22908, United States; Recruiting
Hua Wang, M.D., Ph.D. 434-924-5717 hw2p@virginia.edu
Lawrence H Phillips II, M.D., Principal Investigator
Lawrence H Phillips II, M.D., Principal Investigator
Study chairs or principal investigators
Lawrence H Phillips, M.D., Principal Investigator, University of Virginia
More Information
Study ID Numbers: 11736
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00140218
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00140218
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06
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