NCT00381472CompletedPhase 3
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 393
- Locations
- 77
- Primary Endpoint
- Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
Study Overview
Brief Summary
The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Idiopathic Parkinson's disease
- •Modified Hoehn and Yahr Scale Stages II - IV
- •Stable dose of L-dopa for at least 4 weeks prior to screening.
- •Lack of control with L-dopa therapy.
- •Women of child-bearing potential must use a clinically accepted form of birth control.
Exclusion Criteria
- •Significant and/or uncontrolled medical conditions (excluding Parkinson's disease) within 3 months of screening.
- •Any abnormality, at screening, that is considered clinically relevant by the Investigator.
- •Use of dopamine agonists within 4 weeks of screening visit.
- •Participation in other investigational drug studies.
Outcomes
Primary Outcomes
Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
Secondary Outcomes
- Mean change from baseline in:
- amount and percent of awake time spent "on"
- Unified Parkinson's Disease Rating Scale (UPDRS) total motor score
- percent awake time spent "off"
- UPDRS Activities of Daily Living score
Investigators
Study Sites (77)
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