A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Early Parkinson's Disease
Key facts
- Where
- Majadahonda, SpanyolországSee the site
- Phase
- 2. fázis
Where in Spanyolország
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro MajadahondaMajadahonda, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clinuvel Europe Limited
- Trial code
- EU 2022-502207-30-01
- Record updated
- 2024. június 17.
- Original description
Evaluate the safety of afamelanotide in participants with early PDRead full original descriptionShow less
Evaluate the safety of afamelanotide in participants with early PD
Inclusion: 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: 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; History of drug abuse, licit or illicit; 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; Heavy alcohol consumption; Current cigarette smokers; 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.