Parkinson Disease
Conditions
Keywords
Parkinson's Disease, Dyskinesia, Adjunctive Therapy with L-dopa
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.
Interventions
DRUGRopinirole
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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. * Dementia * Use of dopamine agonists within 4 weeks of screening visit. * Participation in other investigational drug studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in awake time off at Week 24 LOCF (last observation carried forward). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in: | — |
| amount and percent of awake time spent on | — |
| percent awake time spent off | — |
| Unified Parkinson's Disease Rating Scale (UPDRS) total motor score | — |
| UPDRS Activities of Daily Living score | — |
Countries
Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United States
Outcome results
None listed