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R(+)PPX High Dose Treatment of ALS

This study has been completed.
Sponsor:
Information provided by:
Bennett, James P., Jr., M.D., Ph.D.
ClinicalTrials.gov Identifier:
NCT00600873
First received: January 5, 2008
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600873

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

Publications:

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.:
neuroprotection
oxidative stress

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 21, 2013