Cushing's SyndromePhase 2NCT00422201
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion
A Phase 2 study testing Mifepristone in people with Cushing's Syndrome, run by HRA Pharma at 15 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cushing's Syndrome
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 15 May 2007to 4 Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Evidence for Cushing's disease as judged by positive inferior petrosal sinus sampling or a lesion on pituitary MRI with positive CRH test
- Suspected or known adrenocortical cancer or adenomas, as judged by ACTH values less than 10 pg/ml and adrenal mass
- Subjects with cyclic Cushing's syndrome defined by any measurement of Urinary Free Cortisol over the previous 2 months less than 2 N
- Children (age less than 18) and patients over 85 years
- Pregnant or lactating women. A urinary pregnancy test will be performed in women of childbearing potential unless they have a history of menopause prior to Cushing's syndrome or hysterectomy
- Life expectancy less than two months
Show all 25Show fewer
- Surgery planned within 8 weeks after inclusion, especially bilateral adrenalectomy
- Uncontrolled diabetes (plasma glucose greater than 15.0 mmol/L (270 mg/L) and/or HbA1c greater than 10%)
- Uncontrolled hypertension (blood pressure greater than 180/110 mmHg)
- Recent (less than two weeks prior to inclusion) initiation of corrective treatments for depression
- Clinically significantly impaired cardiovascular function (e.g. stage IV cardiac failure)
- Severe liver disease (liver enzymes greater than or equal to 3 x the institutional upper limit of normal range)
- Severe renal impairment (serum creatinine greater than or equal to 2.2 mg/dl or creatinine clearance less than 30 ml/min)
- Severe hypokalemia (plasma K below 3.0 mmol/L)
- Uncontrolled severe active infection
- In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause
- Premenopausal women with hemorrhagic disorders or on anticoagulants
- Recent (less than two weeks prior to inclusion) initiation of or significant change in dose of anti-tumor therapy
- Previous treatment with approved or experimental steroidogenesis inhibitors, somatostatin analogues within one week of admission (eight weeks for patients on octreotide LAR or on lanreotide autogel)
- Plasma mitotane concentration greater than 5 microgram/ml
- Impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent
- Body weight over 136 kg, which is the limit for the tables used in the scanning areas
- Inherited porphyria
- Positive pregnancy test at inclusion
- Use of antiretroviral agents, midazolam, cabergoline, erythromycin, or grapefruit juice within two weeks of the study
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
France7 sites
CHU de Bordeaux Hopital Haut Leveque
Bordeaux
C.H.U Albert Michallon
Grenoble
C.H.U. de Bicetre
Le Kremlin-Bicêtre
CHRU de Lille
Lille
Hopital de la Timone
Marseille
AP-HP, Hopital Cochin Pavillon CORNIL
Paris
CHU de Toulouse
Toulouse
Italy3 sites
Universita Degli Studi
Naples
University of Turin
Orbassano
University of Padova
Padova
Netherlands3 sites
Internal Medicine Endocrinology
Eindhoven
University Hosiptal of Groningen
Groningen
Erasmus Medical Center
Rotterdam
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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 85 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.
Read more
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.
Read the detailed description
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 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 will take mifepristone 600 mg daily by mouth, and the effect on diabetes and other symptoms of Cushing's 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.
- Conditions
- Cushing's Syndrome
- Being tested
- Mifepristone
- Keywords
- Cortisol, Cushing's Syndrome, Ectopic ACTH Secretion, Cushing Syndrome
- Medical subject headings
- Cushing Syndrome, ACTH Syndrome, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Singe dose
| Study group | Role | What they receive |
|---|---|---|
| Prospective, open-label, study of mifepristone | Experimental | Eligible subjects will start study treatment at the dose of 600 mg/day (given as one 200 mg tablet tid, per os). Total duration of treatment will not exceed 12 months. At the end of 12-month treatment, investigators may petition to extend treatment on a case-by-case basis. Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Disorders Improved or Normalized
Criteria for improvement or normalization of glycemic disorders:
- For diabetic patients (known or diagnosed at pre-inclusion visit)
- Decrease in HbA1c > 0.3% B. For patients with IGT
- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL) D. For patients with IFG
If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion:
- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL)
If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0):
- Normalization of fasting plasma glucose (fasting plasma glucose < 5.5 mmol/L (100 mg/dL)
Measured: 8 weeks at steady dose
Secondary outcomes (1)
Features of Cushing's Syndrome
Criteria for secondary glycemic disorder improvement of clinical symptoms attributable to the Cushing's syndrome A. For diabetic patients
- Improvement of the following parameters: glycemic profile, fasting blood glucose, fructosamine, 2-hour OGTT (for diabetics diagnosed at screening)
- Number of anti-diabetics treatment or dose of anti-diabetics treatment for diabetic patients already on diabetes treatment at inclusion
- Doses of insulin for insulin-treated patients B. For patients with IGT
- HbA1c
- Fructosamine C. For patients with IFG
- HbA1c
- Fructosamine D. For all patients
- Fasting plasma insulin
- Area Under the Curve of OGTT results when OGTT performed
- HOMA index
Measured: 8 weeks at steady dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study start15 May 2007
- Primary completion4 Apr 2012
- Study completion4 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cushing's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynnette K Nieman, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422201
- Sponsor's protocol ID
- 070008
- Other IDs
- 07-CH-0008
- Status last verified
- Sep 2019
- First submitted
- 12 Jan 2007
- Last updated
- 11 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bertagna X, Basin C, Picard F, Varet B, Bertagna C, Hucher M, Luton JP. Peripheral antiglucocorticoid action of RU 486 in man. Clin Endocrinol (Oxf). 1988 May;28(5):537-41. doi: 10.1111/j.1365-2265.1988.tb03688.x.
PubMed 3214945Bertagna X, Escourolle H, Pinquier JL, Coste J, Raux-Demay MC, Perles P, Silvestre L, Luton JP, Strauch G. Administration of RU 486 for 8 days in normal volunteers: antiglucocorticoid effect with no evidence of peripheral cortisol deprivation. J Clin Endocrinol Metab. 1994 Feb;78(2):375-80. doi: 10.1210/jcem.78.2.8106625.
PubMed 8106625Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
PubMed 1285753
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00422201
- Acronym / sponsor ID
- 070008
- Conditions
- Cushing's Syndrome
- Keywords
- Cortisol, Cushing's Syndrome, Ectopic ACTH Secretion, Cushing Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2007 (actual)
- Primary completion
- 4 Apr 2012 (actual)
- Study completion
- 4 Apr 2012 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Posted 14 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 85 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:
- 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 (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 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 will take mifepristone 600 mg daily by mouth, and the effect on diabetes and other symptoms of Cushing's 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective, open-label, study of mifepristone | Experimental | Drug: MifepristoneEligible subjects will start study treatment at the dose of 600 mg/day (given as one 200 mg tablet tid, per os). Total duration of treatment will not exceed 12 months. At the end of 12-month treatment, investigators may petition to extend treatment on a case-by-case basis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristoneSinge dose | Drug | Prospective, open-label, study of mifepristone |
Primary outcome
Glycemic Disorders Improved or Normalized
Time frame: 8 weeks at steady dose
Criteria for improvement or normalization of glycemic disorders: A. For diabetic patients (known or diagnosed at pre-inclusion visit) * Decrease in HbA1c > 0.3% B. For patients with IGT * Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL) D. For patients with IFG If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion: - Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL) If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0): - Normalization of fasting plasma glucose (fasting plasma glucose < 5.5 mmol/L (100 mg/dL)
1 secondary outcome
Features of Cushing's Syndrome
Time frame: 8 weeks at steady dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3214945Bertagna X, Basin C, Picard F, Varet B, Bertagna C, Hucher M, Luton JP. Peripheral antiglucocorticoid action of RU 486 in man. Clin Endocrinol (Oxf). 1988 May;28(5):537-41. doi: 10.1111/j.1365-2265.1988.tb03688.x.
- Background: PubMed 8106625Bertagna X, Escourolle H, Pinquier JL, Coste J, Raux-Demay MC, Perles P, Silvestre L, Luton JP, Strauch G. Administration of RU 486 for 8 days in normal volunteers: antiglucocorticoid effect with no evidence of peripheral cortisol deprivation. J Clin Endocrinol Metab. 1994 Feb;78(2):375-80. doi: 10.1210/jcem.78.2.8106625.
- Background: PubMed 1285753Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynnette K Nieman, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone in people with Cushing's Syndrome, run by HRA Pharma at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Italy, Netherlands, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Disorders Improved or Normalized (time frame: 8 weeks at steady dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00422201, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.