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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00479401 |
The objectives of this trial conducted in early PD patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for UPDRS Parts II and III combined), safety, and tolerability of Pramipexole ER (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole.
In addition, the efficacy of Pramipexole IR will be compared to placebo, for assay sensitivity
Condition | Intervention | Phase |
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Parkinson Disease |
Drug: Pramipexol Extended Release Drug: Pramipexol Immediate Release Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-Week Maintenance Phase in Patients With Early Parkinsons Disease (PD). |
Enrollment: | 539 |
Study Start Date: | May 2007 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 248.524, Eudract No 2007-000073-39 |
Study First Received: | May 25, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00479401 |
Health Authority: | Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica); Austria: Federal Office for Safety in Health Care; Czech Republic: SUKL (state institute for drug control); Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy, H-1051 Budapest; India: Drug Control General of India; Japan: Ministry of Health, Labor and Welfare; Malaysia: Ministry of Health, Malaysia; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Slovakia: SUKL (state institute for drug control); Taiwan: Department of Health, Executive Yuan, Taiwan; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Dopamine Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Pramipexol |
Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents |
Dopamine Agonists Protective Agents Pharmacologic Actions Therapeutic Uses Dopamine Agents Central Nervous System Agents |