NCT06302348Phase 3Recruiting

A Study of Sepiapterin in Participants With Phenylketonuria (PKU)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2031-02-28Estimated

Enrollment · participants56Estimated

Source updated2026-08-28Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Phenylketonuria

Treatments or interventions studied

SepiapterinDrugAlso known as PTC923, Sephience

Primary outcomes · main study measures

Read the study measures

measure: Mean Change From Baseline in Full-scale Intelligence Quotient (FSIQ) Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) Score; description: Analysis for participants ≥30 months to \<6 years of age.; timeFrame: Baseline, Year 2; measure: Mean Change From Baseline in FSIQ Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V) Score; description: Analysis for participants ≥6 years to 16 years of age.; timeFrame: Baseline, Year 2

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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