Early Parkinson Disease, Idiopathic, Idiopathic Parkinson Disease, Parkinson, Parkinson Disease, Parkinson's disease
Conditions
Brief summary
Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo Time Frame: From enrollment to the end of treatment at 52 weeks, Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo Time Frame: From enrollment to the end of study at 54 weeks
Detailed description
Change from baseline to Week 52 in motor function/nonmotor as measured by Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)
Interventions
DRUGPlacebo NEU-411 maleate
DRUGNEU-411
Sponsors
Neuron23 Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo Time Frame: From enrollment to the end of treatment at 52 weeks, Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo Time Frame: From enrollment to the end of study at 54 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 52 in motor function/nonmotor as measured by Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) | — |
Countries
Italy, Poland, Spain
Outcome results
None listed