A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

PHASE3CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

September 26, 2017

Primary Completion Date

June 30, 2020

Study Completion Date

August 31, 2020

Conditions
Endogenous Cushing's Syndrome
Interventions
DRUG

Levoketoconazole

"During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily.~During the double-blind Restoration Phase, patients will receive levoketoconazole plus placebo."

DRUG

Placebo

"During the double-blind Withdrawal Phase, patients will receive placebo tablets.~During the double-blind Restoration Phase, patients will receive placebo plus levoketoconazole."

Trial Locations (45)

1088

Semmelweis Egyetem II. Belgyógyászati Klinika A.épület I.emelet ODM-labor, Budapest

1431

Alexandovska University Hospital, Clinic of Endocrinology & Metabolic Diseases, Sofia

"University Multiprofile Hospital for Active Treatment Aleksandrovska EAD Clinic of Endocrinology and Metabolic Diseases", Sofia

University Specialized Hospital for Active Treatment in Endocrinology (USHATE) I Klinika, Sofia

2100

Rigshospitalet, Copenhagen University Hospital, Endocrinology Department, Copenhagen

8031

AOU Federico II, Sezione di Endocrinologia (Edificio 1, Secondo Piano), Napoli

10032

Columbia University, College of P&S Medicine/Neuro-endocrine Unit, New York

10065

Memorial Sloan Kettering Cancer Center, Endocrinology, New York

10126

AOU Citta della Salure e della Scienza SC Endocrinologia, Diabetologia e Metabolismo, Torino

10676

Evangelismos Athens General Hospital, Department of Endocrinology, Athens

11527

General Hospital of Athens 'G. Gennimatas', Department of Endocrinology-Diabetes Centre, Athens

"General Hospital of Athens 'Laiko', National and Kapodistrian University of Athens Medical School Pathophysiology - Endocrinology", Athens

13385

APHM Hôpital de la Conception, Service d'Endocrinologie, Diabète et Maladies Métaboliques, Marseille

15212

Allegheny Neuroendocrinology Center, West Penn Allegheny Health System, Pittsburgh

16132

University of Genova, Department of Internal Medicine & Medical Specialties (DiMI), Genova

21287

Johns Hopkins University, Endocrinology Department, Baltimore

28034

Hospital Universitario Ramón y Cajal, Endocrinology and Nutrition, Madrid

30322

Emory University, Neurosurgery, Atlanta

33312

The Center for Diabetes and Endocrine Care, Fort Lauderdale

34802

Bnai Zion Medical Center, Institute of Endocrinology, Haifa

45110

University General Hospital of Ioannina, Department of Endocrinology, Ioannina

46600

Hospital Universidad De La Ribera, Endocrinologia, Alzira

48109

University of Michigan, Comprehensive Endocrine Research, Internal Medicine - MEND, Ann Arbor

49100

"Rabin Medical Center- Beilinson Hospital, Institute of Endocrinology & Metabolism, Beilinson Campus", Petah Tikva

54642

"Hippokration General Hospital, Endocrinology and Diabetes Department", Thessaloniki

60126

Clinica di Endocrinologia e malattie del Metabolismo, Dipartimento Specialità Mediche, Ancona

60611

Northwestern University, Medicine - Endocrinology, Chicago

63110

Washington University School of Medicine, Endocrinology, St Louis

90033

Keck Medical Center University of Southern California HCII, Internal Medicine - Keck Hospital, Los Angeles

90048

Cedars-Sinai Medical Center, Cedars-Sinai Pituitary Center, Los Angeles

90095

UCLA School of Medicine, Medicine/Endocrinology Department, Los Angeles

97239

Oregon Health & Science University, Neurological Surgery, Portland

98125

AOU Policlinico G. Martino Sezione di Endocrinologia, Messina

300723

"Spitalul Clinic Judetean de Urgenta Pius Brinzeu, Departamentul de Endocrinologie", Timișoara

400349

Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Sectia Clinica Endocrinologie, Cluj-Napoca

540072

Spitalul Clinic Judetean Mures, Compartimentul de Endocrinologie, Târgu Mureş

642-3906

Tel-Aviv Sourasky Medical Center Institute of Endocrinology, Metabolism and Hypertension, Tel Aviv

00168

Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Endocrinology, Roma

00189

Policlinico Universitario Sant'Andrea, Scienze Mediche, Roma

2333ZA

Leiden University, Leiden University Medical Center, Department of Endocrinology, Leiden

3015CE

Erasmus Medical Center, Department of Internal Medicine, Rotterdam

44-101

Maria Sklodowska-Curie Memorial Institute - Cancer Center Gliwice Branch, Nuclear Medicine and Endocrine Oncology Department, Gliwice

93-338

Instytut Centrum Zdrowia Matki Polki, Oddział Endokrynologii i Chorób Metabolicznych, Lodz

04-141

Wojskowy Instytut Medyczny, Klinika Gastroenterologii, Endokrynologii I Chorob Wewnetrznych, Warsaw

011863

Institutul National de Endocrinologie C.I. Parhon, Sectia Clinica de Endocrinologie II, Patologia tiroidei de corelatie, Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cortendo AB

INDUSTRY