SYF230aa6eff7df4372ac8191f53a9b0e5aRegistry ID: 2022-502207-30-01|UnknownPhase 2Results
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interventional
N/A
1 country
1
Evaluate the safety of afamelanotide in participants with early PD
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 18, 2024
Actual (reported)Assessment of Treatment Emergent Adverse Events including clinically significant changes in laboratory results
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
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Formulated product
PRENUMBRA
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SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
PRENUMBRA
Named ingredient: afamelanotide
View registry recordFundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
Majadahonda, 28222, Spain
Information
First Submitted
March 18, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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