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R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by:
Bennett, James P., Jr., M.D., Ph.D.
ClinicalTrials.gov Identifier:
NCT00140218
First received: August 30, 2005
Last updated: January 5, 2008
Last verified: January 2008
History of Changes
  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 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:

U.S. FDA Resources

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%.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140218

Locations
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
Investigators
Principal Investigator: Lawrence H Phillips, M.D. University of Virginia
  More Information

No publications provided

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
pramipexole
oxidative stress
neuroprotection

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

ClinicalTrials.gov processed this record on May 19, 2013