A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients.

NCT00145171 | Completed Phase 3

• 1 other identifier: APO303
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

APO303 is a sub-study of patients enrolled in APO401 (the long-term open label safety protocol) and was designed to evaluate adverse events, particularly blood pressure drops when standing up during first dose in patients who have not been exposed to apomorphine before.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• Entire Study:

• Adverse event assessments

• For Crossover portion of placebo-controlled 4mg dose comparison:

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) at 20 minutes after dosing

Secondary Outcomes (3)

• 1. Change in UPDRS Motor Score from pre-dose to 40 and 90 minutes after dosing;

• 2. Area under the curve (AUC) for UPDRS Motor Scores at 0, 20, 40 and 90 minutes;

• 3. Change in Dyskinesia Assessment at 0, 20, 40, and 90 minutes.

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:

• Age: Adults of any age \> 18.
• Sex: Men and non-pregnant, non-lactating women.
• Women of childbearing potential must have had a negative serum (Beta HCG) pregnancy test within 14 days of the study start.
• Women of childbearing potential must have used an acceptable form of contraception
• Patients with a clinical diagnosis of idiopathic Parkinson's disease, ie. not induced by drugs or caused by other diseases.
• Patients classified as stage II - V of the Hoehn and Yahr scale for staging the severity of Parkinson's disease (Appendix 16.1.12.3).
• Patients with refractory motor fluctuations of any frequency or duration. These included but are not necessarily limited to patients with the following symptoms:
• Immobility resulting from regular dose failures.
• Severe "Off" period discomfort.
• Nocturnal/early morning dystonias.
• Voiding dysfunctions.
• Swallowing difficulties associated with "Off" periods.
• "Off" period visual hallucinations.
• Severe biphasic dyskinesia.
• Unless otherwise specified, enrolled patients must be on an optimally maximized oral therapy regimen. Optimized oral anti-PD medication included: levodopa/carbidopa in either immediate or delayed release forms, plus at least one other antiparkinson medication, which could include a direct acting oral dopamine agonist, a monoamine oxidase inhibitor (MAOB), or a catechol-O-methyltransferase inhibitor (COMT) for at least 30 days prior to enrollment into study.

You may not qualify if:

• Patients with prior exposure to apomorphine, including prior participation in a Mylan sponsored study of subcutaneous apomorphine. Patients were enrolled in APO401 concurrently with APO303.
• Patients under medical therapy for clinically significant psychoses or dementia.
• 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.
• Patients on methyldopa therapy.
• Patients with a history of true allergy to morphine or its derivatives, sulfur, sulfur containing medication, sulfites, trimethobenzamide or other anticholinergics.
• Patients treated with other experimental agents within 30 days before study entry.

Sponsors & Collaborators

• Mylan Bertek Pharmaceuticals: lead

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: February 1, 2001
• Study Completion: August 1, 2002
• Last Updated: September 5, 2005

Record last verified: 2002-11