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| Sponsor: | Mylan Bertek Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Bertek Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00200512 |
Purpose
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 |
|---|---|---|
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| Walton Centre for Neurology and Neurosurgery | |
| Liverpool, United Kingdom | |
| The Morriston Hospital | |
| Swansea, United Kingdom | |
| Study Director: | Will Sullivan | Mylan Bertek Pharmaceuticals |
More Information
| Study ID Numbers: | APO301 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 15, 2005 |
| ClinicalTrials.gov Identifier: | NCT00200512 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Antiparkinson Agents Dopamine Agonists Brain Diseases |
Neurodegenerative Diseases Apomorphine Pharmacologic Actions Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |