At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
ATR-101drug
Likely dose
ATR-101 1000 mgfrom 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 2, Multicenter Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia
In Brief
A Phase 2 clinical trial evaluating ATR-101 for Congenital Adrenal Hyperplasia. Completed, enrolled 10 participants across 6 sites.
Detailed Summary
This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and efficacy of orally administered ATR-101 in subjects with classic congenital adrenal hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to 6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of 5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Adrenal Hyperplasia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMay 2016
First PostedJun 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedJun 17, 2016
Enrollment StartMay 18, 2016
Primary CompletionAug 17, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.0 years ago
Interventions
ATR-101drug
125-1000 mg twice per week