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
  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:


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
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

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
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 August 01, 2014