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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00402233 |
To verify if Mirapex given twice a day, vs three times a day, in early PD patients, is effective and safe.
Condition | Intervention | Phase |
---|---|---|
Parkinson Disease |
Drug: Pramipexole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | A Randomized, Double-Blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-Week Treatment Phase in Early Parkinson's Disease Patients (PramiBID) |
Enrollment: | 311 |
Study Start Date: | November 2006 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 31 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Potential subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study:
Exclusion Criteria:
Individuals with any of the following characteristics will not be eligible for entry into this study:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 248.622, PramiBID |
Study First Received: | November 19, 2006 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00402233 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Ganglion Cysts Antioxidants Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Dopamine Agonists Pramipexol Dopamine Parkinson Disease Movement Disorders Dopamine Agents Parkinsonian Disorders |
Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Dopamine Agonists Brain Diseases |
Neurodegenerative Diseases Protective Agents Pramipexol Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |