The current protocol is designed to satisfy the need for a compassionate use treatment protocol as well as for a long-term open label follow-up study.
The primary objective of APO401 was to gain additional safety data in the outpatient use of apomorphine. APO401 provided an opportunity for all patients who had participated in a Mylan-sponsored placebo controlled trial of apomorphine to receive apomorphine therapy as ambulatory outpatients. Patients other than those enrolled in a Mylan-sponsored study were allowed to participate. Additional data regarding the safety and effectiveness of outpatient use of subcutaneous apomorphine were derived from this experience.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
Mylan Pharmaceuticals
Morgantown, West Virginia, United States
adverse events (AE)s
clinical laboratory tests
vital signs
electrocardiogram
orthostatic monitoring
• Hoehn and Yahr Score
• UPDRS score - Motor Exam (Section III)
• UPDRS score - Total
• UPDRS score - Non-Motor Exam (Subtotal of Sections I, II, and IV)
• UPDRS score - Complications of Therapy (Section IV)
• Number of Off episodes based diary entries
• Duration of Off episodes based on diary entries
• Number of daily injections based on diary entries
• Length of time from injection to On based on diary entries
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