Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa
Phase 3
Completed
- Conditions
- Parkinson Disease
- Registration Number
- NCT00381472
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 393
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.
- Dementia
- Use of dopamine agonists within 4 weeks of screening visit.
- Participation in other investigational drug studies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇪🇸Barcelona, Spain