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

This study has been completed.
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00200525
First received: September 13, 2005
Last updated: December 15, 2005
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Parkinson Disease
Drug: apomorphine HCl injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study of the Continued Efficacy and Safety of SC Apomorphine in the Treatment of Off Episodes in Patients With "On/Off" or "Wearing-Off" Effects Associated With Late-Stage PD After Apomorphine Use

Resource links provided by NLM:


Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:
  • Change in UPDRS Motor Score 20 minutes after dosing of apomorphine or placebo

Secondary Outcome Measures:
  • Percent change in UPDRS Motor Score from pre-dose to 10, 20, and 90 minutes after dosing
  • Area under the curve (AUC) for change in UPDRS Motor Score at 0, 10, 20 and 90 minutes
  • Time to patient-declared onset of relief (max observation time = 40 minutes)
  • Change in Webster Step-Seconds Test score from pre-dose to 2.5, 5, 7.5, 10, 15, 20, 40, and 90 minutes
  • Change in Dyskinesia Assessment from pre-dose to 10, 20 and 90 minutes after dosing

Estimated Enrollment: 60
Study Start Date: July 2001
Estimated Study Completion Date: June 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200525

Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
Investigators
Study Director: Will Sullivan Mylan Bertek Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00200525     History of Changes
Other Study ID Numbers: APO302
Study First Received: September 13, 2005
Last Updated: December 15, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Apomorphine
Emetics
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014