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

This study has been completed.
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00200512
First received: September 13, 2005
Last updated: December 15, 2005
Last verified: March 2000
  Purpose

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


Condition Intervention Phase
Parkinson Disease
Drug: apomorphine HCl injection
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mylan Bertek Pharmaceuticals:

Primary Outcome Measures:
  • UPDRS Motor Score 20 minutes after dosing

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 16
Study Start Date: September 1999
Estimated Study Completion Date: November 1999
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00200512

Locations
United Kingdom
Walton Centre for Neurology and Neurosurgery
Liverpool, United Kingdom
The Morriston Hospital
Swansea, United Kingdom
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
Investigators
Study Director: Will Sullivan Mylan Bertek Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00200512     History of Changes
Other Study ID Numbers: APO301
Study First Received: September 13, 2005
Last Updated: December 15, 2005
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014