A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Early Parkinson's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502207-30-01

Acronym

CUV901

Enrollment

Registered

2024-06-17

Start date

Unknown

Completion date

2024-11-21

Last updated

2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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 to Day 56±2, Changes in inflammation biomarker in plasma from baseline to Day 56±2, Changes in neuromelanin in the MRI series from screening to Day 56±2, Changes in cognition from baseline to Day 56±2, Changes in clinical improvement baseline to Day 56±2

Interventions

DRUGPRENUMBRA

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 to Day 56±2, Changes in inflammation biomarker in plasma from baseline to Day 56±2, Changes in neuromelanin in the MRI series from screening to Day 56±2, Changes in cognition from baseline to Day 56±2, Changes in clinical improvement baseline to Day 56±2	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026