Parkinson’s Disease
Conditions
Brief summary
Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living, as assessed by ≥2-point increase in the MDS-UPDRS Part II score and no improvement (i.e., difference of zero or higher) in the Part III score
Detailed description
• Time from baseline to clinically meaningful progression on motor signs of the disease, as assessed by a ≥5-point increase in the MDS-UPDRS Part III score (key secondary endpoint) • Further Secondary, Exploratory, Safety, Pharmacodynamic, Pharmacokinetics and Pharmacogenomic Endpoints are visible in the study protocol
Interventions
DRUGBIA 28-6156
DRUGPlacebo
Sponsors
Bial R&D Investments S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from baseline to clinically meaningful progression on motor aspects of experiences of daily living, as assessed by ≥2-point increase in the MDS-UPDRS Part II score and no improvement (i.e., difference of zero or higher) in the Part III score | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time from baseline to clinically meaningful progression on motor signs of the disease, as assessed by a ≥5-point increase in the MDS-UPDRS Part III score (key secondary endpoint) • Further Secondary, Exploratory, Safety, Pharmacodynamic, Pharmacokinetics and Pharmacogenomic Endpoints are visible in the study protocol | — |
Countries
France, Germany, Italy, Netherlands, Poland, Portugal, Spain, Sweden
Outcome results
None listed