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Wolff-Parkinson-White Syndrome |
WPW |
Clinical Trial: Stalevo in Early Wearing-Off Patients
This study is not yet open for patient recruitment.
Verified by Orion Pharma July 2005
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Purpose
The purpose of this study is to demonstrate in patients with Parkinson''''s disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
| Condition | Intervention | Phase |
|---|---|---|
| Idiopathic Parkinson''''s Disease | Drug: Stalevo (levodopa/carbidopa/entacapone) | Phase IV |
MedlinePlus related topics: Parkinson''''s Disease
Genetics Home Reference related topics: Parkinson disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients with Parkinson''''s Disease Experiencing Symptoms of Early Wearing-Off
Further Study Details:
Primary Outcomes: The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms.
Secondary Outcomes: Unified Parkinson''''s disease Rating scale; Clinical global Impression of change (investigator); Parkinson''''s disease questionnaire (PDQ-39); Work Impairment Questionnaire
Expected Total Enrollment: 244
Secondary Outcomes: Unified Parkinson''''s disease Rating scale; Clinical global Impression of change (investigator); Parkinson''''s disease questionnaire (PDQ-39); Work Impairment Questionnaire
Expected Total Enrollment: 244
Eligibility
Ages Eligible for Study: 30 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- idiopathic Parkinson''''s disease
- treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
- unchanged antiparkinsonian medication for 6 weeks prior to baseline
Exclusion Criteria:
- secondary of atypical parkinsonism
- patients with daily unpredictable OFF periods or painful dyskinesia
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00125567
Andrew Wighton, BSc (Hons) +44 (0)115 8487 124 andrew.wighton@orionpharma.com
United Kingdom, Wales
University Hospital of Wales, Cardiff, Wales, CF14 4XW, United Kingdom
Bhadravati SD Sastry, FRCPI, FRCP +44 (0)29 2074 3646 dwarak.sastry@cardiffandvale.wales.nhs.uk
Bhadravati SD Sastry, FRCPI, FRCP, Principal Investigator
Bhadravati SD Sastry, FRCPI, FRCP, Principal Investigator
Study chairs or principal investigators
Andrew Wighton, BSc (Hons), Study Director, Orion Pharma
Bhadravati SD Sastry, FRCP, Principal Investigator, University Hospital of Wales and Rookwood Hospital
More Information
Study ID Numbers: 2939111; EudraCT number: 2004-005234-39
Last Updated: August 1, 2005
Record first received: July 29, 2005
ClinicalTrials.gov Identifier: NCT00125567
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medicinal Devices; Ireland: Irish Medicines Board; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Finland: National Agency for Medicines
ClinicalTrials.gov processed this record on 2005-08-02
Last Updated: August 1, 2005
Record first received: July 29, 2005
ClinicalTrials.gov Identifier: NCT00125567
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medicinal Devices; Ireland: Irish Medicines Board; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Finland: National Agency for Medicines
ClinicalTrials.gov processed this record on 2005-08-02
Resources
- Wolff-Parkinson-White Syndrome (Cleveland Clinic)
- Wolff-Parkinson-White syndrome (Google Health)
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