Study to measure the continued effectiveness of apomorphine after previous exposure of at
least three months duration.
Percent change in UPDRS Motor Score from pre-dose to 10, 20, and 90 minutes after dosingArea under the curve (AUC) for change in UPDRS Motor Score at 0, 10, 20 and 90 minutes
Time to patient-declared onset of relief (max observation time = 40 minutes)
Change in Webster Step-Seconds Test score from pre-dose to 2.5, 5, 7.5, 10, 15, 20, 40, and 90 minutes
Change in Dyskinesia Assessment from pre-dose to 10, 20 and 90 minutes after dosing
Inclusion Criteria:
- Adults of any age ≥ 18
- Men and non-pregnant, non-lactating women
- Women of childbearing potential had a negative serum (Beta HCG) pre-study pregnancy
test prior to randomization
- Women of childbearing potential used an acceptable form of contraception
- Patients with a clinical diagnosis of idiopathic Parkinson's Disease, i. e., not
induced by drugs or caused by other diseases;
- Patients classified as stage (II-IV) of the Hoehn and Yahr scale for staging the
severity of Parkinson's Disease
- The patient must have been on an optimally maximized oral therapy regimen. Optimized
oral anti-parkinson medications must have included levodopa/carbidopa inhibitors, in
either immediate or delayed release forms, plus at least one direct acting oral
dopamine agonist for at least 30 days prior to randomization
- Patients must have been receiving apomorphine subcutaneous injections for rescue
therapy for Off events for at least three months
- The minimum apomorphine baseline-dosing requirement was an average of at least 2 doses
per day over the week prior to enrollment.
- Patients participating in protocol APO401, an open-label study primarily designed to
collect safety data, were eligible for participation in this trial without termination
of participation in APO401
Exclusion Criteria:
- Patients under medical therapy for clinically significant psychoses or dementia not
related to ingestion of anti-parkinson medications. (Patients with hallucinations or
other central adverse reactions associated solely with anti-parkinson medications were
not excluded.)
- Patients with a history of drug or alcohol dependency within one year prior to study
enrollment
- Patients with unstable and clinically significant disease of cardiovascular (including
orthostatic hypotension), hematologic (including Coombs' positive hemolytic anemia),
hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems
or neoplasm within the three months before the start of the study.
- Patinets with a history of true allergy to morphine or its derivatives (including
apomorphine), sulfur, sulfur containing medications, sulfites, sulfates,
Tigan(R)(trimethobenzamide).
- Patients treated with experimental agents (other than apomorphine intermittent
subcutaneous injections) within 30 days before study entry. Patients with
participation in MYLAN-sponsored study APO202 were excluded from participation in this
study.
- Patients whose apomorphine regimen was characterized by administration methods other
than intermittent subcutaneous injection.
- Patients who could not or would not sign an Informed Consent form.
