Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145171
Status:
COMPLETED
Last Update Posted:
2005-09-05
First Post:
2005-09-02
Brief Title:
A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients
Sponsor:
Mylan Bertek Pharmaceuticals
Organization:
Mylan Bertek Pharmaceuticals
Study Overview
Official Title:
Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinsons Disease Patients A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg
Status:
COMPLETED
Status Verified Date:
2002-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 Parkinsons 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 04-mL titration level placebo was randomly introduced under double-blind crossover conditions
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 04-mL titration level placebo was randomly introduced under double-blind crossover conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None