Parkinson's Disease
Conditions
Brief summary
Assessment of Treatment Emergent Adverse Events including clinically significant changes in laboratory results.
Detailed description
Changes in α-synuclein levels in plasma from baseline (Day 1) to Day 56±2, Changes in inflammation biomarker in plasma from baseline (Day 1) to Day 56±2, Changes in cognition from baseline (Day 1) to Day 56±2, Changes in the NM in the MRI series from screening to Day 56±2, Changes in clinical improvement baseline (Day 1) to Day 56±2
Interventions
DRUGPRENUMBRA
Sponsors
Clinuvel Europe Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Treatment Emergent Adverse Events including clinically significant changes in laboratory results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in α-synuclein levels in plasma from baseline (Day 1) to Day 56±2, Changes in inflammation biomarker in plasma from baseline (Day 1) to Day 56±2, Changes in cognition from baseline (Day 1) to Day 56±2, Changes in the NM in the MRI series from screening to Day 56±2, Changes in clinical improvement baseline (Day 1) to Day 56±2 | — |
Countries
Italy
Outcome results
None listed