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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200512
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 16, 2005
Information provided by:
Mylan Bertek Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: apomorphine HCl injection Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : September 1999
Study Completion Date : November 1999

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. UPDRS Motor Score 20 minutes after dosing

Secondary Outcome Measures :
  1. Dyskinesia Rating Scale 10, 20 and 60 minutes after dosing
  2. Time to onset of perceived relief
  3. AUC for UPDRS Motor Scores at predose, 10, 20 and 60 minutes
  4. Change in UPDRS Motor Scores at 10 and 60 minutes after dosing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200512

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United Kingdom
Walton Centre for Neurology and Neurosurgery
Liverpool, United Kingdom
The Morriston Hospital
Swansea, United Kingdom
Sponsors and Collaborators
Mylan Bertek Pharmaceuticals
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Study Director: Will Sullivan Mylan Bertek Pharmaceuticals
Layout table for additonal information Identifier: NCT00200512    
Other Study ID Numbers: APO301
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 16, 2005
Last Verified: March 2000
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action