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Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day

Expanded access is temporarily not available for this treatment.
Sponsor:
Collaborators:
University of Pittsburgh
University of Nebraska
Information provided by (Responsible Party):
Bennett, James P., Jr., M.D., Ph.D.
ClinicalTrials.gov Identifier:
NCT00596115
First received: January 5, 2008
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

R(+) pramipexole dihydrochloride monohydrate [R(+)PPX], an experimental neuroprotective drug, is provided in this open label extension study to ALS patients who have participated in earlier clinical protocols.


Condition Intervention
Amyotrophic Lateral Sclerosis
 Drug: R(+) pramipexole dihydrochloride monohydrate

Study Type: Expanded Access     What is Expanded Access?
Official Title: Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day

Resource links provided by NLM:

U.S. FDA Resources

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

Intervention Details:
    Drug: R(+) pramipexole dihydrochloride monohydrate
    20 mg tid per day orally
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Definite diagnosis of ALS

Exclusion Criteria:

  • No prior participation in R(+)PPX clinical studies
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bennett, James P., Jr., M.D., Ph.D.
ClinicalTrials.gov Identifier: NCT00596115     History of Changes
Other Study ID Numbers: 12316
Study First Received: January 5, 2008
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

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 22, 2013