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| Sponsor: | Mylan Bertek Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Bertek Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00200525 |
Purpose
Study to measure the continued effectiveness of apomorphine after previous exposure of at least three months duration.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease |
Drug: apomorphine HCl injection |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Placebo-Controlled Study of the Continued Efficacy and Safety of SC Apomorphine in the Treatment of Off Episodes in Patients With "On/Off" or "Wearing-Off" Effects Associated With Late-Stage PD After Apomorphine Use |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | June 2002 |
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
More Information
| Study ID Numbers: | APO302 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 15, 2005 |
| ClinicalTrials.gov Identifier: | NCT00200525 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |