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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-004679-36
    Sponsor's Protocol Code Number:05 2015-001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-09-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2006-004679-36
    A.3Full title of the trial
    Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
    A.3.2Name or abbreviated title of the trial where available
    HRA052015 in EAS
    A.4.1Sponsor's protocol code number05 2015-001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNone
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratoire HRA Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/298
    D.3 Description of the IMP
    D.3.2Product code HRA052015
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmifepristone
    D.3.9.1CAS number 84371-65-3
    D.3.9.3Other descriptive name17β-hydroxy-11β-(4-dimethylaminophenyl)17α-(prop-1-ynyl)estra-4,9-dien-3-one
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10014155
    E.1.2Term Ectopic corticotrophin syndrome
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate that daily administration of mifepristone in subjects with Cushing's syndrome caused by ectopic ACTH secretion will improve the glucocorticoid-dependent parameters of blood pressure and/or glucose tolerance.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the impact of long-term administration of mifepristone on other glucocorticoid-dependent parameters, and the safety of the agent. The clinical and biochemical features and safety parameters which will be evaluated are detailed in protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be included if they have ALL of the three following criteria:

    1. Hypercortisolism from Cushing’s syndrome caused by ectopic ACTH secretion confirmed by:
    - Inferior petrosal sinus sampling (IPSS) with a central to peripheral ACTH ratio of less than 2.0 before CRH administration and less than 3.0 after CRH administration.
    - or biopsy with ACTH immunoreactivity.
    - or presence of a tumor evidenced by imaging combined with both a negative CRH test and a negative 8 mg dexamethasone suppression test.
    No major change in tumor status/anti-tumor therapy should be expected during the study

    AND
    2. Glucose intolerance AND/OR hypertension that is considered to be caused or worsened by the hypercortisolism:
    o Diabetes defined by
     fasting plasma glucose level ≥ 7.0 mmol/l (126 mg/dl)
     or 2-hour glucose plasma level after 75 g OGTT ≥ 11.1 mmol/l (200 mg/dl)
     or treated diabetes
    or glucose intolerance defined by:
     fasting plasma glucose values between 5.5 mmol/l (100 mg/dl) and 7.0 mmol/l (126 mg/dl) or 2-hour glucose plasma level after 75 g OGTT ≥ 7.8 mmol/l (140 mg/dl) ) and < 11.1 mmol/l (200 mg/dl)
     Prior to study entry, fasting blood sugar must be less than 11.1 mmol/l (200 mg/dl) for at least two weeks
    o Hypertension defined by
     systolic BP ≥ 140 mm Hg and/or diastolic BP ≥ 90 mm Hg
     Prior to study entry, BP must be less than 180/110 mmHg for at least two weeks
     or treated hypertension

    AND
    3. At least one of the following symptoms attributable to the Cushing’s syndrome:
    o Body weight increase or truncal obesity
    o Depression or treated depression or psychiatric disorder
    o Fatigue
    o Proximal muscle weakness
    o Hirsutism
    o Hypokalemia
    o Bruising
    o Violaceous striae
    o In men, gynecomastia or libido decrease
    o Impaired cognition or memory
    o Hyperpigmentation
    o Amenorrhea
    o Osteopenia or osteoporosis

    In addition, the following criteria should be met:
    - Written informed consent to participate in the study
    - Female subjects should be sterilized, post-menopausal, sexually inactive or willing to use barrier methods of contraception throughout the study.
    - Subject willing to return to investigational site during the full course of the study
    - Age in the range of 18 to 75 years inclusive
    E.4Principal exclusion criteria
    - 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 < 10 pg/ml and adrenal mass
    - Subjects with cyclic Cushing’s syndrome defined by at least 3 measurements of Urinary Free Cortisol over the previous two months without normal values.
    - Children (age less than 18) and subject of more than 75 years of age
    - 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 three months
    - Severe uncontrolled diabetes
    - Grade III or IV hypertension
    - Recent (less than two weeks prior to inclusion) initiation of corrective treatments for diabetes, hypertension or depression
    - Clinically significantly impaired cardiovascular function (e.g. stage IV cardiac failure)
    - Severe liver disease (liver enzymes ≥ 3 x the institutional upper limit of normal range)
    - Severe renal impairment (serum creatinine ≥ 2.2 mg/dl or creatinine clearance < 30 ml/min)
    - Uncontrolled severe active infection
    - In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause
    - Recent (less than two weeks prior to inclusion) initiation of or significant change in dose of anti-tumor therapy
    - Treatment with approved or experimental steroidogenesis inhibitors, adrenolytic agents or somatostatin analogues within four weeks of admission
    - Plasma mitotane concentration > 5 µg/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
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of primary efficacy data will be based on:
    Blood pressure (supine blood pressure) and glucose tolerance (fasting glucose in diabetes and 2-hour OGTT in glucose intolerance) measured at visit P and additional visits M1 to M3 as applicable.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 22
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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