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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pramipexole
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 September 14, 2014