A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Entire Study:
- Adverse event assessments
- For Crossover portion of placebo-controlled 4mg dose comparison:
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) at 20 minutes after dosing
- 1. Change in UPDRS Motor Score from pre-dose to 40 and 90 minutes after dosing;
- 2. Area under the curve (AUC) for UPDRS Motor Scores at 0, 20, 40 and 90 minutes;
- 3. Change in Dyskinesia Assessment at 0, 20, 40, and 90 minutes.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145171
|Study Director:||Will Sullivan||Mylan Bertek Pharmaceuticals|