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Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome (PROMPT)

This study is currently recruiting participants.
Verified February 2017 by HRA Pharma
Sponsor:
ClinicalTrials.gov Identifier:
NCT02297945
First Posted: November 21, 2014
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
HRA Pharma
  Purpose
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.

Condition Intervention Phase
Cushing's Syndrome Drug: metyrapone Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single Arm, Open-label, Multicenter, International Study to Assess the Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome During a 12-week Treatment Period Followed by an Extension Period of 24 Weeks

Resource links provided by NLM:


Further study details as provided by HRA Pharma:

Primary Outcome Measures:
  • Normalization of cortisol levels (urinary free cortisol) [ Time Frame: 3 months ]

Estimated Enrollment: 70
Study Start Date: April 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metyrapone
Metyrapone will be administered orally in an open-label fashion. Two possible initiation doses will be used depending on the severity of hypercortisolism, dose will then be adjusted (up or down-titrated) during the first month on an individual basis according to clinical tolerance and cortisol levels achieved.
Drug: metyrapone
Single arm study
Other Name: Metopirone

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients with endogenous Cushing's syndrome:

  • 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;
  • Patients with ectopic ACTH syndrome (either occult, after surgery failure, or inoperable or metastatic);
  • Patients with Cushing's syndrome from adrenal causes

Exclusion Criteria:

  1. Pseudo Cushing's syndrome
  2. Cyclic Cushing's syndrome defined by at least one normal UFC value among at least three 24-hour urinary sampling measurements over the previous 2 months
  3. Advanced adrenocortical carcinoma or ectopic ACTH secretion (EAS) secondary to a small cell lung carcinoma
  4. Life expectancy less than 3 months
  5. Pituitary or adrenal surgery or pituitary irradiation or surgery of the ACTH-secreting ectopic tumor or bilateral adrenalectomy planned before the week 12 visit
  6. Pituitary irradiation within the previous 5 years (for Cushing's disease patients)
  7. Enlarged pituitary adenoma (greater than 1 cm in vertical diameter and leaving less than 2 mm from the chiasma) or compression of the optic chiasma on the pituitary MRI for patients with Cushing's disease
  8. Severe uncontrolled hypertension (>180/110 mmHg) despite anti-hypertensive therapy (for otherwise eligible patients, blood pressure medication may be adjusted to meet this criterion)
  9. Severe hypokalemia (< 2.5 mmol/L) despite corrective measures
  10. White blood cell counts <3 x 109 /L; hemoglobin <10 g/dL; platelets <100 x 109 /L
  11. Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that in the judgment of the investigator, would present excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297945


Locations
Belgium
University hospital Antwerp Not yet recruiting
Antwerp, Belgium
CHU Erasme Recruiting
Brussels, Belgium
Contact: Driessens, Dr    +32 2 5553131      
University hospital Saint Luc Recruiting
Brussels, Belgium
Contact: Maiter, Prof    +32 2 764 11 11      
CHU Liège Recruiting
Liege, Belgium
Contact: Beckers, Prof    +32 4 242 52 00      
Germany
Charité Berlin Not yet recruiting
Berlin, Germany, 10117
Contact: Tina Kienitz, Dr    +49 30 45050      
Universitätsklinikum Essen Recruiting
Essen, Germany
Contact: Führer-Sakel, Prof    +49 201 7230      
Munich university Recruiting
Munich, Germany
Contact: Beuschlein, Prof    +49 89 440052100      
University hospital Wuerzburg Recruiting
Wuerzburg, Germany
Contact: Fassnacht, Prof    +49 931 2010      
Hungary
State health center Not yet recruiting
Budapest, Hungary, 10062
Contact: Laszlo Kovacs, Dr         
Contact    06 465-1800 3.      
Semmelweis Egyetem II. Belgyógyászati Klinika Recruiting
Budapest, Hungary
Contact: Toth, Dr    +36 1 266 0926      
University Debrecen Not yet recruiting
Debrecen, Hungary
Contact: Endre Nagy, Dr         
University of Pecs Recruiting
Pecs, Hungary
Contact: Mezosi, Dr    +36 72 501 599      
University of Szeged Not yet recruiting
Szeged, Hungary
Contact: Zsuzsanna Valkusz, Prof         
Italy
San Luigi Gonzaga Hospital, University of Turin Recruiting
Orbassano, Turin, Italy, 10043
Contact: Massimo Terzolo, Prof    +39 011 90261      
Grande Ospedale Metropolitano Niguarda Recruiting
Milan, Italy
Contact: Loli, Dr    +39 02 6444.1      
Ospedale San Luca IRCCS Istituto Auxologico Italiano Recruiting
Milan, Italy
Contact: Cavagnini, Prof    +39 02 619111      
S. Giuseppe Hospital Recruiting
Milan, Italy
Contact: Arosio, Dr    +39 0575 37341      
Federico II University Recruiting
Naples, Italy
Contact: Pivonello, Prof    +39 081 253 1111      
University of Padova Recruiting
Padova, Italy
Contact: Boscaro, Prof    +39 049 827 5111      
University of Turin Recruiting
Turin, Italy
Contact: Ghigo, Dr    +39 011 670 6111      
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Not yet recruiting
Gliwice, Poland
Contact: Barbara Jarzab, Prof         
University Hospital Recruiting
Krakow, Poland
Contact: Motyka, Dr    +48 12 424 70 00      
University Clinical Hospital Not yet recruiting
Wrocław, Poland
Contact: Marek Bolanowski, Prof    +48 71 327 09 00      
Spain
University hospital clinic of Barcelona Recruiting
Barcelona, Spain
Contact: Hanzu, Dr    +34 932 27 54 00      
Hospital Universitario La Ribera Recruiting
Valencia, Spain
Contact: Fajardo, Dr    +34 962 45 81 00      
Turkey
Ankara Numune Training and Research Hospital Not yet recruiting
Ankara, Turkey
Contact: Dilek Berker, Prof         
Dokuz Eylul UMF Not yet recruiting
Izmir, Turkey
Contact: Baris Akinci, Prof         
Ondokuz Mayıs University Medical Faculty Not yet recruiting
Samsun, Turkey
Contact: Aysegül Atmaca, Prof         
Karadeniz Teknik University Not yet recruiting
Trabzon, Turkey
Contact: Mustafa Koçak, Prof         
Sponsors and Collaborators
HRA Pharma
  More Information

Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT02297945     History of Changes
Other Study ID Numbers: HRA112025-002
First Submitted: November 19, 2014
First Posted: November 21, 2014
Last Update Posted: February 15, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Metyrapone
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors