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

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University of Pittsburgh
University of Nebraska
Information provided by (Responsible Party):
Bennett, James P., Jr., M.D., Ph.D. Identifier:
First received: January 5, 2008
Last updated: July 24, 2012
Last verified: July 2012
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:

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

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Definite diagnosis of ALS

Exclusion Criteria:

  • No prior participation in R(+)PPX clinical studies
  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.

No Contacts or Locations Provided
  More Information

Responsible Party: Bennett, James P., Jr., M.D., Ph.D. 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:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents processed this record on October 20, 2016