Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422201
Status:
TERMINATED
Last Update Posted:
2019-10-11
First Post:
2007-01-12
Brief Title:
Prospective Open-Label Multicenter International Study of Mifepristone for Symptomatic Treatment of Cushings Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone ACTH Secretion
Sponsor:
HRA Pharma
Organization:
HRA Pharma
Study Overview
Official Title:
Prospective Open-Label Multicenter International Study of Mifepristone for Symptomatic Treatment of Cushings Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone ACTH Secretion
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate whether the drug mifepristone can improve the symptoms of Cushings syndrome in people with ectopic adrenal corticotrophin hormone ACTH secretion Cushings syndrome occurs when the adrenal glands produce too much cortisol a hormone that helps to regulate the bodys 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 Cushings 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 Cushings syndrome and patients with certain kinds of cancer gynecological diseases and psychiatric disorders
People between 18 and 85 years of age with Cushings syndrome caused by EXCESS ACTH secretion may be eligible for this study Candidates are admitted to the hospital for evaluation to confirm Cushings 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 Cushings 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
Physical examination electrocardiogram EKG and blood and urine tests
Completion of medical questionnaires
DEXA scan to determine bone mineral density and body composition
Glucose tolerance test
Urine pregnancy test and ultrasound to measure uterine lining thickness for women
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
People between 18 and 85 years of age with Cushings syndrome caused by EXCESS ACTH secretion may be eligible for this study Candidates are admitted to the hospital for evaluation to confirm Cushings 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 Cushings 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
Physical examination electrocardiogram EKG and blood and urine tests
Completion of medical questionnaires
DEXA scan to determine bone mineral density and body composition
Glucose tolerance test
Urine pregnancy test and ultrasound to measure uterine lining thickness for women
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
Detailed Description:
Between 10 and 20 of patients with hypercortisolism Cushings 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 diabetes or other symptoms of Cushings 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 will take mifepristone 600 mg daily by mouth and the effect on diabetes and other symptoms of Cushings syndrome will be measured Subjects will return to the hospital at 2 3 6 9 and 12 months after starting mifepristione for evaluation of diabetes and other symptoms The agent will be available for up to 12 months for patients in whom it is effective
Patients take mifepristone by mouth 3 times a day Each dose will contain 200 mg Patients may remain in the hospital for all or part of the initial safety studies every two weeks for eight weeks During this period blood pressure glucose tolerance and blood chemistries are measured and EKG and urinalysis done every two weeks The mifepristone dose can be decreased or stopped if there are adverse effects When the mifepristone dose is stable for eight weeks patients will be re-evaluated Patients then return to the hospital for evaluations one month later and then every 3 months Those who do well on the drug may continue to take it for up to 12 months
Patients take mifepristone by mouth 3 times a day Each dose will contain 200 mg Patients may remain in the hospital for all or part of the initial safety studies every two weeks for eight weeks During this period blood pressure glucose tolerance and blood chemistries are measured and EKG and urinalysis done every two weeks The mifepristone dose can be decreased or stopped if there are adverse effects When the mifepristone dose is stable for eight weeks patients will be re-evaluated Patients then return to the hospital for evaluations one month later and then every 3 months Those who do well on the drug may continue to take it for up to 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-CH-0008 | None | None | None |