Last updated on February 2018

Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome

Brief description of study

The purpose of this prospective, international phase III/IV study is to assess the efficacy and safety of metyrapone in patients with endogenous Cushing's syndrome during up to 36 weeks of treatment. The ability of metyrapone (250 mg capsules) to normalize urinary free cortisol (UFC) levels will be assessed during up to 36 weeks (9 months) of treatment.

Detailed Study Description

This study will include Cushing disease patients with persistent or recurrent disease (after pituitary surgery) or who are newly diagnosed but are unsuitable for early surgery or wish to defer surgery. It will also include patients with ectopic ACTH syndrome (either occult, after surgery failure, or inoperable or metastatic) and patients with Cushing's syndrome from adrenal causes.

The ability of metyrapone to normalize urinary free cortisol levels will be assessed during up to 36 weeks (9 months) of treatment. Patients participating in this study and who are controlled or close to the target at the end of a 3-months period may continue with an optional extension period of 6 months in which the long-term efficacy and safety profiles of metyrapone will be assessed. This extension study is intended to provide new findings to consolidate existing efficacy and safety data on metyrapone in the treatment of Cushing's syndrome.

Clinical Study Identifier: NCT02297945

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University hospital Antwerp
Antwerp, Belgium
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Driessens, Dr

CHU Erasme
Brussels, Belgium
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Maiter, Prof

University hospital Saint Luc
Brussels, Belgium
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Beckers, Prof

CHU Li ge
Liege, Belgium
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Tina Kienitz, Dr

Charit Berlin
Berlin, Germany
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Führer-Sakel, Prof

Universit tsklinikum Essen
Essen, Germany
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Beuschlein, Prof

Munich university
Munich, Germany
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Fassnacht, Prof

University hospital Wuerzburg
Wuerzburg, Germany
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Laszlo Kovacs, Dr

State health center
Budapest, Hungary
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Toth, Dr

Semmelweis Egyetem II. Belgy gy szati Klinika
Budapest, Hungary
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Endre Nagy, Dr

University Debrecen
Debrecen, Hungary
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Mezosi, Dr

University of Pecs
Pecs, Hungary
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Zsuzsanna Valkusz, Prof

University of Szeged
Szeged, Hungary
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Massimo Terzolo, Prof

San Luigi Gonzaga Hospital, University of Turin
Orbassano, Italy
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Loli, Dr

Grande Ospedale Metropolitano Niguarda
Milan, Italy
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Cavagnini, Prof

Ospedale San Luca IRCCS Istituto Auxologico Italiano
Milan, Italy
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Arosio, Dr

S. Giuseppe Hospital
Milan, Italy
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Pivonello, Prof

Federico II University
Naples, Italy
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Boscaro, Prof

University of Padova
Padova, Italy
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Ghigo, Dr

University of Turin
Turin, Italy
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Barbara Jarzab, Prof

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Gliwice, Poland
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Motyka, Dr

University Hospital
Krakow, Poland
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