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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Laboratoire HRA Pharma |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00422201 |
This study will evaluate whether the drug mifepristone can improve the symptoms of Cushing's syndrome in people with ectopic adrenal corticotrophin hormone (ACTH) secretion. Cushing's syndrome occurs when the adrenal glands produce too much cortisol, a hormone that helps to regulate the body's use of salt and food. Excessive cortisol is usually the result of too much ACTH, the hormone that causes the adrenal glands to make cortisol. The extra ACTH is made either by a tumor in the pituitary gland (called Cushing's disease) or by a tumor somewhere else (called ectopic ACTH secretion). Mifepristone blocks the action of cortisol in the body. The drug has been used safely to treat a few people with Cushing's syndrome and patients with certain kinds of cancer, gynecological diseases and psychiatric disorders.
People between 18 and 75 years of age with Cushing's syndrome caused by EXCESS ACTH secretion may be eligible for this study. Candidates are admitted to the hospital for evaluation to confirm Cushing's syndrome and to determine its cause. The evaluation includes blood and urine tests, imaging tests, dexamethasone and corticotropin-releasing hormone tests and inferior petrosal sinus sampling. Patients determined to have Cushing's syndrome due to ECTOPIC ACTH secretion undergo imaging studies (CT, MRI and a nuclear medicine scan) and begin mifepristone therapy.
Participants remain in the hospital for the following tests and procedures:
Patients take mifepristone by mouth 3 times a day. The dose is increased every week or so until symptoms improve or the highest dosage allowed is reached. Patients may remain in the hospital for all or part of the dose-finding part of the study. During this period (usually 2 to 4 weeks), blood pressure, glucose tolerance and blood chemistries are measured and EKG and urinalysis done every 5 to 14 days. When the mifepristone dose is stable patients remain on that dose for at least 2 weeks and are then re-evaluated. Patients then return to the hospital for evaluations every 3 months. Those who do well on the drug may continue to take it for up to 12 months.
Condition | Intervention | Phase |
---|---|---|
Cushing's Syndrome |
Drug: Mifepristone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion |
Estimated Enrollment: | 30 |
Study Start Date: | December 2006 |
Between 10% and 20% of patients with hypercortisolism (Cushing's Syndrome) have tumoral ectopic production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. If an ectopic tumor cannot be found or if surgery cannot be done, the treatment options include medicines that reduce cortisol production and bilateral adrenalectomy. The available medications that reduce cortisol production have important adverse effects and are not effective in some patients and adrenalectomy leads to lifelong requirements for medical hormone replacement. Thus, additional treatment options would be welcome. This study evaluates a potential new medication for the treatment of these patients; mifepristone blocks the effects of cortisol rather than decreasing its production. The purpose of this study is to see whether this agent can improve high blood pressure, diabetes or other symptoms of Cushing's syndrome in subjects with ectopic ACTH secretion. Another purpose is to evaluate adverse effects with this drug. Patients with presumed ectopic ACTH secretion and diabetes or hypertension will take mifepristone by mouth, and the effect on diabetes, hypertension and other symptoms of Cushing's syndrome will be measured. The dose of mifepristone will be increased every week or so if symptoms do not improve. Once the mifepristone dose is stable, subjects will return to the hospital every three months for evaluation of diabetes, hypertension and other symptoms. The agent will be available for up to 12 months for patients in whom it is effective.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Subjects will be included if they have ALL of the three following criteria:
Hypercortisolism from Cushing's syndrome caused by ACTH ectopic secretion
AND
Glycemic disorder that is considered to be caused or worsened by the hypercortisolism
AND
At least one symptom attributable to the Cushing's syndrome.
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
France | |
C.H.U. de Bicetre | Recruiting |
Kremlin-Bicetre, France | |
AP-HP, Hopital Cochin Pavillon CORNIL | Recruiting |
Paris, France | |
CHU de Bordeaux Hopital Haut Leveque | Recruiting |
Bordeaux, France | |
CHRU de Lille | Recruiting |
Lille, France | |
C.H.U Albert Michallon | Recruiting |
Grenoble, France | |
CHU de Toulouse | Recruiting |
Toulouse, France | |
Hopital de la Timone | Recruiting |
Marseille, France | |
Germany | |
University of Wuerzburg | Recruiting |
Wuerzbug, Germany | |
Italy | |
University of Turin | Recruiting |
Orbassano, Italy | |
University of Padova | Recruiting |
Padova, Italy | |
Universita Degli Studi | Recruiting |
Napoli, Italy | |
Netherlands | |
Internal Medicine Endocrinology | Recruiting |
Eindhoven, Netherlands | |
Erasmus Medical Center | Recruiting |
Rotterdam, Netherlands | |
University Hosiptal of Groningen | Recruiting |
Groningen, Netherlands | |
United Kingdom | |
University of Birmingham, The Medical School | Recruiting |
Birmingham, United Kingdom | |
University of Sheffield, Royal Hallamshire Hospital | Recruiting |
Sheffield, United Kingdom | |
Education Centre, Christie Hospital NHS Trust | Recruiting |
Withington Manchester, United Kingdom | |
St. Bartholomew's Hospital | Recruiting |
London, United Kingdom | |
University of Glasgow | Recruiting |
Glasgow, United Kingdom | |
Addenbrookes Hospital | Recruiting |
Cambridge, United Kingdom | |
Univ. of Newcastle & Newcastle Univ. Hospital NHS Trust | Recruiting |
Newcastle, United Kingdom |
Responsible Party: | ( Lisa Duranteau, M.D. ) |
Study ID Numbers: | 070008, 07-CH-0008 |
Study First Received: | January 12, 2007 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00422201 |
Health Authority: | United States: Federal Government |
Cortisol Cushing's Syndrome Ectopic ACTH Secretion Cushing Syndrome |
Hydrocortisone Cortisol succinate Cushing Syndrome Endocrine System Diseases Adrenal Gland Diseases Mifepristone |
Hydrocortisone acetate Endocrinopathy Epinephrine Adrenocortical Hyperfunction Cardiac Complexes, Premature Adrenocorticotropic Hormone |
Abortifacient Agents, Steroidal Contraceptives, Postcoital, Synthetic Disease Contraceptive Agents Hormone Antagonists Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents |
Luteolytic Agents Contraceptives, Postcoital Hormones Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic |