R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

This study has been completed.
University of Pittsburgh
Information provided by:
Bennett, James P., Jr., M.D., Ph.D.
ClinicalTrials.gov Identifier:
First received: August 30, 2005
Last updated: January 5, 2008
Last verified: January 2008
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 1
Phase 2

Bennett, James P., Jr., M.D., Ph.D. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

Further study details as provided by Bennett, James P., Jr., M.D., Ph.D.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FVC taken each month [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 months ] [ Designated as safety issue: No ]
  • hand dynamometry taken each month [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2005
Study Completion Date: December 2006
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: R(+) pramipexole dihydrochloride monohydrate
    10 mg tid oral
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%.

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00140218

United States, Pennsylvania
David Lacomis MD
Pittsburgh, Pennsylvania, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Bennett, James P., Jr., M.D., Ph.D.
University of Pittsburgh
Principal Investigator: Lawrence H Phillips, M.D. University of Virginia
  More Information

Responsible Party: James P. Bennett Jr. M.D. Ph.D. Sponsor, University of Virginia
ClinicalTrials.gov Identifier: NCT00140218     History of Changes
Other Study ID Numbers: 11736 
Study First Received: August 30, 2005
Last Updated: January 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Bennett, James P., Jr., M.D., Ph.D.:
amyotrophic lateral sclerosis
oxidative stress

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Anti-Dyskinesia Agents
Antiparkinson Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 24, 2016