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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
apomorphine HCl injection
Sponsored by
Mylan Bertek Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Walton Centre for Neurology and Neurosurgery
  • The Morriston Hospital

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
December 15, 2005
Sponsor
Mylan Bertek Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00200512
Brief Title
Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months
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 Type
Interventional

2. Study Status

Record Verification Date
March 2000
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mylan Bertek Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
apomorphine HCl injection
Primary Outcome Measure Information:
Title
UPDRS Motor Score 20 minutes after dosing
Secondary Outcome Measure Information:
Title
Dyskinesia Rating Scale 10, 20 and 60 minutes after dosing
Title
Time to onset of perceived relief
Title
AUC for UPDRS Motor Scores at predose, 10, 20 and 60 minutes
Title
Change in UPDRS Motor Scores at 10 and 60 minutes after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Will Sullivan
Organizational Affiliation
Mylan Bertek Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Walton Centre for Neurology and Neurosurgery
City
Liverpool
Country
United Kingdom
Facility Name
The Morriston Hospital
City
Swansea
Country
United Kingdom

12. IPD Sharing Statement

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

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