Status:
COMPLETED
A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's
Lead Sponsor:
GlaxoSmithKline
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with a diagnosis of advanced idiopathic Parkinson's disease (according to modified Hoehn \& Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa.
- Exclusion criteria:
- Patients with late stage advanced Parkinson's disease with incapacitating dyskinesias on a stable dose of L-dopa.
- Current, or history of, (within the previous 3 months), significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy.
- Recent history of severe dizziness or fainting on standing.
- Dementia, neurotic behaviour, crippling degenerative arthritis or limb amputations, or prior or current major psychosis.
- Recent history or current evidence of drug abuse or alcoholism.
- Use of a dopamine agonist within 4 weeks of starting the study.
- Personal or family history of an allergic reaction to ropinirole.
Exclusion
Key Trial Info
Start Date :
June 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2007
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT00331149
Start Date
June 20 2006
End Date
August 29 2007
Last Update
August 22 2017
Active Locations (81)
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1
GSK Investigational Site
Sofia, Bulgaria, 1113
2
GSK Investigational Site
Sofia, Bulgaria, 1527
3
GSK Investigational Site
Varna, Bulgaria, 9010
4
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3J 3T1