Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months
This study has been completed.
Sponsor:
Mylan Bertek Pharmaceuticals
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00200512
First received: September 13, 2005
Last updated: December 15, 2005
Last verified: March 2000
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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:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Apomorphine hydrochloride
U.S. FDA Resources
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 |
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
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 May 21, 2013