Long Term Safety and Efficacy of SC Apomorphine in Treatment of "Off" Episodes in Late-Stage Parkinson's Disease

NCT00142545 | Completed Phase 3

• 1 other identifier: APO401
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The current protocol is designed to satisfy the need for a compassionate use treatment protocol as well as for a long-term open label follow-up study.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• adverse events (AE)s

• clinical laboratory tests

• vital signs

• electrocardiogram

• orthostatic monitoring

Secondary Outcomes (9)

• • Hoehn and Yahr Score

• • UPDRS score - Motor Exam (Section III)

• • UPDRS score - Total

• • UPDRS score - Non-Motor Exam (Subtotal of Sections I, II, and IV)

• • UPDRS score - Complications of Therapy (Section IV)

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, i.e., 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.
• Patients with refractory motor fluctuations of any frequency or duration. These include 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.
• The patient (or a caregiver) had to be able to recognize an Off state, and be sufficiently motivated to learn how to use the apomorphine injection to control these periods.

You may not qualify if:

• Patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of anti-PD medications. (Patients with hallucinations or other central adverse reactions associated solely with anti-PD 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.
• Patients with a history of true allergy to morphine or its derivatives (including apomorphine), sulfur, sulfur containing medication, 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 Bertek-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.

Sponsors & Collaborators

• Mylan Bertek Pharmaceuticals: lead

Study Sites (1)

Mylan Pharmaceuticals

Morgantown, West Virginia, 26505, United States

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

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: July 1, 1999
• Study Completion: July 1, 2005
• Last Updated: September 2, 2005

Record last verified: 2005-07

Locations

US (1)