Clin2
NCT06302348Possibly a fitRecruiting

Sepiapterin study for phenylketonuria

Phenylketonuria

Part of Brain & nervous system, Genetic & congenital, Hormones & metabolism clinical trials.

This study tests a new medicine called sepiapterin to see if it can help control blood phenylalanine levels in people with PKU. The trial aims to find a safe and effective dose for different age groups.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
56 people
Ages
Up to 9 years
Study type
Interventional

Who can take part

  • You must be diagnosed with PKU and have high blood phenylalanine levels in your medical history.
  • Your recent blood phenylalanine levels must be within a specific range (120 to 480 micromol/L).
  • If you are a woman who could become pregnant, you must agree to use contraception.
  • You must be willing to stick to a controlled diet (prescribed protein and phenylalanine) during the trial.
  • You cannot have taken certain PKU medicines (like Kuvan) in the last 3 months.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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