A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy 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: 20.0Level: PTClassification code: 10061536Term: Parkinson's disease Class: 100000004852; MedDRA version: 20.0Level: HLTClassification code: 10034005Term: Parkinson's disease and parkinsonism Class: 10029205; MedDRA version: 21.1Level: LLTClassification code: 10013113Term: Disease Parkinson's Class: 10029205; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-502207-30-01
• Lead Sponsor: Clinuvel Europe Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Patient diagnosed with PD less than three years prior to first screening visit 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