At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 154 enrolled
Drug / intervention
Trofinetidedrug
Likely dose
Trofinetide 60 mLfrom 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 40-Week, Open-label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
In Brief
A Phase 3 clinical trial evaluating Trofinetide for Rett Syndrome. Completed, enrolled 154 participants across 21 sites.
Detailed Summary
To investigate the safety and tolerability of long-term treatment with oral trofinetide in girls and women with Rett syndrome
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRett Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJan 2020
First PostedFeb 2020
Primary CompletionAug 2022
TodayJul 2026
First PostedFeb 21, 2020
Enrollment StartJan 29, 2020
Primary CompletionAug 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.4 years ago
Interventions
Trofinetidedrug
Trofinetide solution of 30-60 mL based on subject's weight at Baseline, administered twice daily by mouth or gastrostomy tube (G-tube)