R(+)PPX High Dose Treatment of ALS

This study has been completed.
Information provided by:
Bennett, James P., Jr., M.D., Ph.D.
ClinicalTrials.gov Identifier:
First received: January 5, 2008
Last updated: September 10, 2010
Last verified: September 2010
R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative stress.

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: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months

Resource links provided by NLM:

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

Primary Outcome Measures:
  • decline in ALSFRS score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma PPX levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • CSF PPX levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients with early ALS
Drug: R(+) pramipexole dihydrochloride monohydrate
100 mg tid orally daily


Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • definite ALS no prior exposure to R(+)PPX

Exclusion Criteria:

  • ALSFRS at baseline <40 FVC at baseline <70%
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00600873

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Bennett, James P., Jr., M.D., Ph.D.
Principal Investigator: Ted M Burns, MD University of Virginia
  More Information

Responsible Party: James P. Bennett Jr. M.D. Ph.D. Sponsor, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00600873     History of Changes
Other Study ID Numbers: 13023 
Study First Received: January 5, 2008
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bennett, James P., Jr., M.D., Ph.D.:
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 25, 2016