Parkinson Disease
Conditions
Brief summary
1. Change from Baseline to Week 12 in average daily OFF time on motor diaries for 150 mg CVN424 compared to placebo (normalized to waking hours).
Detailed description
1. Change from baseline to end of the study treatment (week 12) compared to placebo assessed in several questionnaires and scales used during the study., 2. Safety is assessed by the number of patients reporting treatment emergent adverse events and serious adverse events; number of patients with clinically significant changes in the physical examination, vital signs, 12-lead ECG and laboratory data.
Interventions
DRUGfilm-coated tablets for oral administration
DRUGCVN424
Sponsors
Cerevance Beta Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from Baseline to Week 12 in average daily OFF time on motor diaries for 150 mg CVN424 compared to placebo (normalized to waking hours). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline to end of the study treatment (week 12) compared to placebo assessed in several questionnaires and scales used during the study., 2. Safety is assessed by the number of patients reporting treatment emergent adverse events and serious adverse events; number of patients with clinically significant changes in the physical examination, vital signs, 12-lead ECG and laboratory data. | — |
Countries
Czechia, France, Italy, Poland, Spain
Outcome results
None listed