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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Single arm study
Normalization of cortisol levels (urinary free cortisol)
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University hospital Antwerp
Antwerp, Belgium
CHU Erasme
Brussels, Belgium
University hospital Saint Luc
Brussels, Belgium
CHU Liège
Liège, Belgium
Charité Berlin
Berlin, Germany
Universitätsklinikum Essen
Essen, Germany
Munich university
Munich, Germany
University hospital Wuerzburg
Würzburg, Germany
State health center
Budapest, Hungary
Semmelweis Egyetem II. Belgyógyászati Klinika
Budapest, Hungary
...and 26 more locations