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

NCT00200512 | Completed Phase 2

• 1 other identifier: APO301
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• UPDRS Motor Score 20 minutes after dosing

Secondary Outcomes (4)

• 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

Interventions

apomorphine HCl injection DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Bertek Pharmaceuticals: lead

Study Sites (2)

Walton Centre for Neurology and Neurosurgery

Liverpool, United Kingdom

Location

The Morriston Hospital

Swansea, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings

Study Officials

• Will Sullivan

  Mylan Bertek Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 1999
• Study Completion: November 1, 1999
• Last Updated: December 16, 2005

Record last verified: 2000-03

Locations

GB (2)