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

NCT ID: NCT00200525

Last Updated: 2005-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2002-06-30

Brief Summary

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

apomorphine HCl injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan Bertek Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Will Sullivan

Role: STUDY_DIRECTOR

Mylan Bertek Pharmaceuticals

Other Identifiers

APO302

Identifier Type: -

Identifier Source: org_study_id