- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00596115
Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day
July 24, 2012 updated by: Bennett, James P., Jr., M.D., Ph.D.
Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day
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.
Study Overview
Status
Temporarily not available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Definite diagnosis of ALS
Exclusion Criteria:
- No prior participation in R(+)PPX clinical studies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 5, 2008
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimate)
January 16, 2008
Study Record Updates
Last Update Posted (Estimate)
July 25, 2012
Last Update Submitted That Met QC Criteria
July 24, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Sclerosis
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Dopamine Agonists
- Dopamine Agents
- Antioxidants
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Pramipexole
Other Study ID Numbers
- 12316 (Other Identifier: City of Hope Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amyotrophic Lateral Sclerosis
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Ruijin HospitalActive, not recruitingALS (Amyotrophic Lateral Sclerosis) | ALS - Amyotrophic Lateral SclerosisChina
-
ZIWIGMonitoring Force GroupActive, not recruitingAmyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis, SporadicFrance
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Washington University School of MedicineMassachusetts General HospitalSuspendedAmyotrophic Lateral Sclerosis, Familial | Amyotrophic Lateral Sclerosis, SporadicUnited States
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Synchron, Inc.RecruitingALS (Amyotrophic Lateral Sclerosis) | Motor Neuron Disease | ALS | Neurological Disorder | ALS - Amyotrophic Lateral SclerosisUnited States
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National Institute of Neurological Disorders and...RecruitingAmyotrophic Lateral Sclerosis Type 4 | Inherited Neurological Disorders of RNA ProcessingUnited States
-
Massachusetts General HospitalNot yet recruitingALS (Amyotrophic Lateral Sclerosis) | ALS | ALS - Amyotrophic Lateral Sclerosis
-
Biocells MedicalActive, not recruitingAmyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular DisordersPoland
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Groupe Hospitalier du HavreFrench Physiotherapy Society / Société Français de PhysiothérapieRecruitingAmyotrophic Lateral Sclerosis ALS7France
-
Nova Southeastern UniversityRecruitingAmyotrophic Lateral Sclerosis (ALS) | Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Primary Lateral Sclerosis (PLS)United States
-
Tanabe Pharma CorporationCompletedAmyotrophic Lateral Sclerosis (ALS)
Clinical Trials on R(+) pramipexole dihydrochloride monohydrate
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Bennett, James P., Jr., M.D., Ph.D.Completed
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Bennett, James P., Jr., M.D., Ph.D.University of PittsburghCompleted
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Suzhou Zelgen Biopharmaceuticals Co.,LtdCompleted
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Haisco Pharmaceutical Group Co., Ltd.Completed
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Boehringer IngelheimCompleted
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Teva Pharmaceuticals USACompleted
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Teva Pharmaceuticals USACompleted
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Virginia Commonwealth UniversityAlzheimer's Drug Discovery Foundation; University of KansasCompletedAlzheimer's DiseaseUnited States
-
Areteia TherapeuticsActive, not recruitingChronic Obstructive Pulmonary DiseaseUnited States
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Areteia TherapeuticsTerminatedEosinophilic AsthmaUnited States, Argentina, Brazil, Bulgaria, Georgia, Poland, Romania, Serbia, South Africa, Ukraine, United Kingdom, Japan, Mexico, North Macedonia, South Korea