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R(+)PPX High Dose Treatment of ALS

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.
 
ClinicalTrials.gov Identifier: NCT00600873
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : September 13, 2010
Sponsor:
Information provided by:
Bennett, James P., Jr., M.D., Ph.D.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: R(+) pramipexole dihydrochloride monohydrate Phase 1 Phase 2

Expanded Access : 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
patients with early ALS
 Drug: R(+) pramipexole dihydrochloride monohydrate
100 mg tid orally daily


Outcome Measures
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Primary Outcome Measures :
  1. decline in ALSFRS score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. plasma PPX levels [ Time Frame: 6 months ]
  2. CSF PPX levels [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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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): NCT00600873


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

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Responsible Party: James P. Bennett Jr. M.D. Ph.D. Sponsor, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00600873    
Other Study ID Numbers: 13023
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010
Keywords provided by Bennett, James P., Jr., M.D., Ph.D.:
neuroprotection
oxidative stress
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
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