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R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140218
First Posted: September 1, 2005
Last Update Posted: January 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Pittsburgh
Information provided by:
Bennett, James P., Jr., M.D., Ph.D.
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • FVC taken each month [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 months ]
  • hand dynamometry taken each month [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: January 8, 2008
Last Verified: January 2008

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
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents