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A Study of Sepiapterin in Participants With Phenylketonuria (PKU)

Study acronym: EPIPHENY
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study Status, Eligibilityv16
  2. Study sites: 8 to 10v15
  3. Re-verified, no change to tracked fieldsv14
  4. Trial sites expanded: 5 → 8 locationsv13
  5. Study sites: 1 to 5
    • Study description revised
    • Eligibility criteria expanded, about 2 words
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Eligibility criteria revisedv10
  3. 5 versions Re-verified since Nov 5, 2024, no change to tracked fieldsv5-v9
  4. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 1 word
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 29, 2024 to Mar 4, 2024
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood.
Trial Details
NCT Number NCT06302348
Lead Sponsor PTC Therapeutics
Conditions
(from sponsor)		 Phenylketonuria
Related terms Phenylketonurias
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov