A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Cushing Syndrome
In brief
This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101 to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous Cushing's syndrome. Following wash-out (if needed), all eligible subjects will enter an open-label intra-subject dose-escalation period of 8 weeks' duration, followed either by a double-blind randomized withdrawal period of 4 weeks' duration (if the subject meets randomization criteria) or by an additional open label dosing period of 4 weeks' duration (if the subject does not meet randomization criteria).It is anticipated that the overall duration of the study per subject will range from approximately 16-22 weeks.
Key facts
- Study ID
- NCT03053271
- Run by
- Millendo Therapeutics US, Inc.
- People needed
- 4
- Starts
- 2017-04-13
- Expected to finish
- 2019-08-12
- Last updated by the study team
- 2021-03-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of endogenous Cushing's syndrome
- Baseline UFC 1.3 to 10 × upper limit of normal (ULN)
- If previous pituitary surgery, participants must be at least 3 months since surgery at the time of screening
- BMI between 18 and 60 kg/m2, inclusive
You may not qualify if…
- Pseudo-Cushing's syndrome, cyclic Cushing's syndrome or current iatrogenic Cushing's syndrome
- Candidates for surgical treatment of Cushing's syndrome, unless surgery is not anticipated to occur during the study
- Normal late night salivary cortisol or 24-hr urine free cortisol
- Radiotherapy of the pituitary within 6 months
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- The James Cook University Hospital — Middlesbrough, United Kingdom
Full record on ClinicalTrials.gov
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