Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons Disease

Mylan

Status and phase

Completed

Phase 3

Conditions

Parkinson Disease

Treatments

Drug: apomorphine HCl injection

Study type

Interventional

Funder types

Industry

Identifiers

APO302

Details and patient eligibility

About

Study to measure the continued effectiveness of apomorphine after previous exposure of at least three months duration.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.