Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months

Condition(s) targeted: Parkinson Disease

Intervention: apomorphine HCl injection (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Mylan Bertek Pharmaceuticals

Official(s) and/or principal investigator(s):
Will Sullivan, Study Director, Affiliation: Mylan Bertek Pharmaceuticals

The objective of this study was to measure the continued efficacy of apomorphine after previous exposure of at least three months duration.

Official title: A Prospective, Randomized, Placebo-Controlled, Crossover Study of the Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of "Off" Episodes in Patients With "On/Off" or "Wearing Off" Effects Associated With Late Stage Parkinson's Disease

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: UPDRS Motor Score 20 minutes after dosing

Secondary outcome:

Dyskinesia Rating Scale 10, 20 and 60 minutes after dosing

Time to onset of perceived relief

AUC for UPDRS Motor Scores at predose, 10, 20 and 60 minutes

Change in UPDRS Motor Scores at 10 and 60 minutes after dosing

Detailed description: This was a prospective, double-blind, randomized, placebo-controlled, crossover desigh, multicenter study of the safety and effectiveness of subcutaneous apomorphine treatment. Patients received both apomorphine and placebo, in a randomized double-blind fashion

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients diagnosed with idiopathic Parkinson's Disease and classified as stage II-IV

of the Hoehn and Yahr scale for staging the severity of Parkinson's Disease

- Patients must have been on an optimally maximized oral therapy regimen including

levodopa/decarboxylase 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 with an average dosing requirement of at least 2 doses per day over the week prior to enrollment with a dose of less than 11 mg

Exclusion Criteria:

- Patients under medical therapy for clinically significant psychoses or dementia not

related to ingestion of antiparkinson medications. (Patients with hallucinations or other central adverse reactions associated solely with antiparkinson 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 threemonths before the start of the study.

- Patients with a history of allergy or intolerance to morphine or its derivatives,

sulfur, sulfur containing medication, sulfites, domperidone, trimethobenzamide or other anticholinergics.

- Patients treated with experimental agents (other than apomorphine intermittent

subcutaneous injections) within 3 months before study entry, experimental agents were defined on the basis of the regulatory status in the country of patient observation, or with other disallowed medications

- Patients whose apomorphine regimen was characterized by continuous infusion or by

administration methods other than intermittent subcutaneous injection.

- Patients who could not or would not sign an informed consent form.

Walton Centre for Neurology and Neurosurgery, Liverpool, United Kingdom

The Morriston Hospital, Swansea, United Kingdom

Starting date: September 1999
Ending date: November 1999
Last updated: December 15, 2005