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Sponsored by: |
Mylan Bertek Pharmaceuticals |
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Information provided by: | Mylan Bertek Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00200512 |
The objective of this study was to measure the continued efficacy of apomorphine after previous exposure of at least three months duration.
Condition | Intervention | Phase |
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Parkinson Disease |
Drug: apomorphine HCl injection |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Placebo-Controlled, Crossover Study of the Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of "Off" Episodes in Patients With "On/Off" or "Wearing Off" Effects Associated With Late Stage Parkinson's Disease |
Estimated Enrollment: | 16 |
Study Start Date: | September 1999 |
Estimated Study Completion Date: | November 1999 |
This was a prospective, double-blind, randomized, placebo-controlled, crossover desigh, multicenter study of the safety and effectiveness of subcutaneous apomorphine treatment. Patients received both apomorphine and placebo, in a randomized double-blind fashion
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Walton Centre for Neurology and Neurosurgery | |
Liverpool, United Kingdom | |
The Morriston Hospital | |
Swansea, United Kingdom |
Study Director: | Will Sullivan | Mylan Bertek Pharmaceuticals |
Study ID Numbers: | APO301 |
Study First Received: | September 13, 2005 |
Last Updated: | December 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00200512 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Dopamine Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Apomorphine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Antiparkinson Agents Dopamine Agents Dopamine Agonists Central Nervous System Agents Pharmacologic Actions |