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

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 20.0Level: SOCClassification code: 10029205Term: Nervous system disorders Class: 8; MedDRA version: 21.1Level: LLTClassification code: 10013113Term: Disease Parkinson's Class: 10029205; MedDRA version: 20.0Level: HLTClassification code: 10034005Term: Parkinson's disease and parkinsonism Class: 10029205; MedDRA version: 20.0Level: PTClassification code: 10061536Term: Parkinson's disease Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-502207-30-00
• Lead Sponsor: Clinuvel Europe Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patient diagnosed with PD less than three years prior to first screening visits and not yet requiring dopaminergic medication nor expected to within three months of enrolment., 40-85 years old

Exclusion Criteria

History of drug abuse, licit or illicit., Participation in any clinical intervention study during the six weeks before the study screening period., Any medical condition or illness in the four weeks before the study screening which may interfere with the study protocol or not suitable for study participation in the opinion of the Investigator., Heavy alcohol consumption., Current cigarette smokers., Any personal or immediate family history of melanoma or personal history of dysplastic nevus syndrome, Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins, Any evidence of hepatic insufficiency or renal impairment., Female who is pregnant or lactating., Females of child-bearing potential not using highly effective contraceptive measures, for up to three months after the last injection administration., Sexually active men with a partner of child-bearing potential who is not using highly effective contraceptive measures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - Evaluate the safety of afamelanotide in patients with early PD following treatment with afamelanotide;Secondary Objective: Evaluate the changes in a-synuclein in blood in patients with early PD after treatment with afamelanotide, Evaluate the changes in inflammation in patients with early PD following treatment with afamelanotide, Evaluate the changes in cognition in patients with early PD following treatment with afamelanotide, Evaluate the changes in neuromelanin (NM) in patients with early PD after treatment with afamelanotide, Evaluate the clinical improvement in patients with early Parkinson’s disease (PD) following treatment with afamelanotide;Primary end point(s): Assessment of Treatment Emergent Adverse Events including clinically significant changes in laboratory results.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Changes in a-synuclein levels in plasma from baseline (Day 1) to Day 56±2;Secondary end point(s):Changes in inflammation biomarker in plasma from baseline (Day 1) to Day 56±2;Secondary end point(s):Changes in cognition from baseline (Day 1) to Day 56±2;Secondary end point(s):Changes in the NM in the MRI series from screening to Day 56±2;Secondary end point(s):Changes in clinical improvement baseline (Day 1) to Day 56±2