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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00466167 |
The general aim of this trial is 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 qd, in comparison to placebo, in L-Dopa+ treated Parkinson patients with advanced PD and motor fluctuations. In addition, a numerical comparison of the efficacy of pramipexole ER versus pramipexole IR will be done.
The efficacy of pramipexole IR will also be compared to placebo, for assay sensitivity.
Condition | Intervention | Phase |
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Parkinson Disease |
Drug: Pramipexole |
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 L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD). |
Enrollment: | 518 |
Study Start Date: | April 2007 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 32 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: | 248.525 |
Study First Received: | April 25, 2007 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00466167 History of Changes |
Health Authority: | Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna; Czech Republic: SUKL (state institute for drug control); Great Britain: MHRA; Hungary: National Institute of Pharmacy, H-1051 Budapest; India: Drug Control General of India; Italy: Comitato di Bioetica Az. Policlinico di Catania - CATANIA; Korea, Republic of: Korea Food and Drug Administration (KFDA); Philippines: Department of Health, Republic of the Philippines; Poland: Registration Medicinal Product Medical Device Biocidal Product; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Spain: Spanish Agency for Medicines and Health Products; Sweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, Sweden; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) |
Neurotransmitter Agents Levodopa Ganglion Cysts Antioxidants Basal Ganglia Diseases Central Nervous System Diseases Dopamine Agonists Brain Diseases |
Neurodegenerative Diseases Pramipexol Dopamine Parkinson Disease Movement Disorders Dihydroxyphenylalanine 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 |