At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 157 enrolled
Drug / intervention
PTC923 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study of PTC923 in Subjects With Phenylketonuria
In Brief
A Phase 3 clinical trial evaluating PTC923 and Placebo for Phenylketonuria. Completed, enrolled 157 participants across 43 sites in 15 countries.
Detailed Summary
The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria
CountriesAustralia, Brazil, Canada, Denmark, France, Georgia, Germany, Italy, Mexico, Netherlands, Portugal, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartSep 2021
First PostedOct 2021
Primary CompletionApr 2023
Study CompletionMay 2023
TodayJul 2026
First PostedOct 29, 2021
Enrollment StartSep 30, 2021
Primary CompletionApr 3, 2023
Study CompletionMay 3, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.7 years ago
Interventions
PTC923drug
PTC923 powder for oral use will be suspended in water or apple juice prior to administration.
Placebodrug
Placebo matching to PTC923