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Sponsored by: |
Mylan Bertek Pharmaceuticals |
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Information provided by: | Mylan Bertek Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00145171 |
APO303 is a sub-study of patients enrolled in APO401 (the long-term open label safety protocol) and was designed to evaluate adverse events, particularly blood pressure drops when standing up during first dose in patients who have not been exposed to apomorphine before.
Condition | Intervention | Phase |
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Parkinson Disease |
Drug: apomorphine HCl injection |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg. |
Estimated Enrollment: | 56 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | August 2002 |
The primary objective of this study was to determine the electrocardiographic and orthostatic effects of apomorphine during controlled in-patient dose introduction in apomorphine-naïve late stage Parkinson’s disease patients. Although safety observations represented the primary objective of the study, a control group was considered essential to properly interpret adverse events that occurred during dose titration. Additional data comparing the efficacy and safety of subcutaneous apomorphine, placebo and standard antiparkinson (anti-PD) therapy was derived from this experience.
This was a two-phase study that involved a controlled in-office dose titration phase followed by a 6-month outpatient open-label treatment phase. During the in-patient dose titration phase, subjects were evaluated on separate days for the response to single doses of medication administered during an observed “Off” event (defined as first “Off” event that occurs at least one hour after administration of the normal morning dose of oral antiparkinson medication). Evaluation of the acute response to oral anti-PD medication (Baseline) and to apomorphine dose escalation between 2 and 10 mg (Titration Visits) was conducted under unblinded conditions. At the 0.4-mL titration level, placebo was randomly introduced under double-blind crossover conditions.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Sex: Men and non-pregnant, non-lactating women.
Patients with refractory motor fluctuations of any frequency or duration. These included but are not necessarily limited to patients with the following symptoms:
Exclusion Criteria:
Study ID Numbers: | APO303 |
Study First Received: | September 2, 2005 |
Last Updated: | September 2, 2005 |
ClinicalTrials.gov Identifier: | NCT00145171 |
Health Authority: | 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 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 |