A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:2/17/2019
Start Date:February 16, 2017
End Date:November 2020
Contact:Marian Ijzerman, PhD
Email:ijzerman@millendo.com
Phone:734-845-9300

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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing's Syndrome

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
10
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Beverly Biller, MD
Phone: 617-726-7473
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: T. Brooks Vaughan III, MD
Phone: 205-934-4112
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Bournemouth, Dorset BH7 7DW
Principal Investigator: Tristan Richardson, MD
Phone: +44 120 270 4344
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Laurence Kennedy, MD
Phone: 216-444-7955
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Lawrence Kirschner, MD
Phone: 614-688-3785
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1975 Zonal Avenue
Los Angeles, California 90089
Principal Investigator: John Carmichael, MD
Phone: 323-865-1225
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: James Findling, MD
Phone: 414-955-7468
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Kevin Yuen, MD
Phone: 602-406-6274
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Portland, Oregon 97227
Principal Investigator: Maria Fleseriu, MD
Phone: 503-494-9546
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Rochester, Minnesota 55905
Principal Investigator: Alice Chang, MD
Phone: 507-266-1944
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