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    Summary
    EudraCT Number:2017-000980-33
    Sponsor's Protocol Code Number:42847922ISM2005
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-000980-33
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects with Insomnia Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind study to evaluate the efficacy and safety of JNJ-42847922 in subjects with insomnia disorder
    A.4.1Sponsor's protocol code number42847922ISM2005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031 0715242166
    B.5.5Fax number00310715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-42847922 2.5mg
    D.3.2Product code JNJ-42847922
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNseltorexant
    D.3.9.1CAS number 1452539-75-1
    D.3.9.2Current sponsor codeJNJ-42847922-AAA
    D.3.9.3Other descriptive nameAs Per IMPD
    D.3.9.4EV Substance CodeSUB32046
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    D.IMP: 2
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-42847922 10 mg
    D.3.2Product code JNJ-42847922
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNseltorexant
    D.3.9.1CAS number 1452539-75-1
    D.3.9.2Current sponsor codeJNJ-42847922-AAA
    D.3.9.3Other descriptive nameAs Per IMPD
    D.3.9.4EV Substance CodeSUB32046
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    D.IMP: 3
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-42847922 20 mg
    D.3.2Product code JNJ-42847922
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNseltorexant
    D.3.9.1CAS number 1452539-75-1
    D.3.9.2Current sponsor codeJNJ-42847922-AAA
    D.3.9.3Other descriptive nameAs Per IMPD
    D.3.9.4EV Substance CodeSUB32046
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Stilnoct
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namezolpidem tartrate
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNAs Per SmPC
    D.3.9.1CAS number As Per SmPC
    D.3.9.2Current sponsor codeAs Per SmPC
    D.3.9.3Other descriptive nameZOLPIDEM TARTRATE PH. EUR.
    D.3.9.4EV Substance CodeSUB173362
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Insomnia Disorder
    E.1.1.1Medical condition in easily understood language
    Sleeplessness (Sleep disorder where people have trouble sleeping)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10078083
    E.1.2Term Insomnia disorder
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the dose-response of 3 doses of JNJ-42847922 (5, 10, and 20 mg) compared to placebo on an objective measure of sleep onset
    in subjects with insomnia disorder.
    E.2.2Secondary objectives of the trial
    1. To assess the dose-response of 3 doses of JNJ-42847922 (5, 10, and 20 mg) compared to placebo on an objective measure of maintenance of sleep in subjects with insomnia disorder.
    2. To assess the effect of JNJ-42847922 compared with placebo in improving additional objective sleep parameters.
    3. To assess the effect of JNJ-42847922 compared with zolpidem in improving objective sleep parameters.
    4.To assess the effect of JNJ-42847922 compared with zolpidem and placebo on self-reported measures of sleep.
    5. To assess the effect of JNJ-42847922 compared with zolpidem and placebo in improving: Response and remission of insomnia symptoms and clinical severity and improvement of insomnia symptoms.
    6. To assess the safety and tolerability of JNJ-42847922 compared with zolpidem and placebo in subjects with insomnia disorder.

    (Please refer to protocol for additional secondary objectives)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 'Subject must be a man or WONCBP, 18 to 85 years of age, inclusive, on the day of signing informed consent. Note: Subjects should be at least 18 years of age or older as per the legal age of consent in the jurisdiction in which the study is taking place.
    A WONCBP is defined as:
    o Postmenopausal
    A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (per central laboratory range) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy.
    o Permanently sterile
    Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.
    If reproductive status is questionable, additional evaluation should be considered.'
    2. Subject must meet DSM-5 criteria for insomnia disorder.
    •A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
    – Difficulty initiating sleep
    – Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings
    – Early-morning awakening with inability to return to sleep.
    •The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
    •The sleep difficulty occurs at least 3 nights per week.
    •The sleep difficulty is present for at least 3 months.
    •The sleep difficulty occurs despite adequate opportunity for sleep.
    •The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (eg, narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).
    •The insomnia is not attributable to the physiological effects of a substance (eg, a drug of abuse, a medication).
    •Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
    3. Subject must have an ISI total score ≥15 at screening.
    (Note: For subjects taking hypnotic drugs at the time of signing the informed consent form [ICF], administration of the ISI must occur at least 5 days after the last dose of all hypnotic drugs.)
    4. Subject must have an sSOL ≥45 minutes and an sWASO ≥60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the CSD-M, prior to screening PSG assessments.(Note: For subjects taking hypnotic drugs at the time of signing the ICF, administration of the CSD-M must start at least 5 days after the last dose of all hypnotic drugs.)
    5. Subject must demonstrate a 2-night mean LPS of ≥25 minutes (with neither night <20 minutes), a 2-night mean WASO ≥30 minutes, and a 2-night mean TST ≤6.5 hours, with neither night >7 hours.

    (Please refer to protocol for additional inclusion criteria)
    E.4Principal exclusion criteria
    1.Has history of or current clinically significant and/or unstable liver (moderate or severe hepatic impairment [Child-Pugh Score ≥7]) or renal insufficiency (severe renal impairment [estimated creatinine clearance below 30 mL/min]; serum creatinine >2 mg/dL); significant and/or unstable cardiac, vascular, pulmonary (eg. Acute or severe respiratory failure), gastrointestinal, endocrine, neurologic (eg myasthenia gravis, narcolopsy), hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma, and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study (eg, medically frail subject with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is exclusionary.
    Note: Subjects with chronic but stable, well-controlled conditions may be allowed in the study upon agreement with the investigator and the sponsor's Safety Physician
    2. Has uncontrolled hypertension (supine systolic blood pressure >150 mm Hg in adult subjects or >160 mm Hg in elderly subjects or supine diastolic blood pressure >90 mm Hg, despite diet, exercise, or a stable dose of allowed antihypertensive therapy)
    at screening or Day 1. (A subject with hypertension may be included if the subject’s hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months).
    3. Has clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. Subjects with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c [HbA1c] ≤8%) may be eligible to participate if
    otherwise medically healthy. It is expected that laboratory values will generally be within the normal range, though minor deviations, which are not considered to be of clinical significance to both the investigator and the sponsor’s Safety Physician, are acceptable.
    4. Has clinically significant ECG abnormalities at screening or Day 1 prior to randomization defined as: QT interval corrected according to Fridericia’s formula: ≥450 msec (males); ≥470 msec (females). Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval >210 msec, left bundle branch block. Features of new ischemia and other clinically important arrhythmia.
    Note: Subjects with right bundle branch block may be allowed provided confirmation that right bundle branch block is not associated with underlying cardiac/lung diseases.
    5. Has significant hypersomnia not related to night time insomnia (based on clinical judgment of the investigator).
    6. Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan andintent) for ideation on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1. Subjects with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan within the past 6 months, should be carefully screened for current suicidal ideation and only subjects with non-serious items (1-3 of the suicidal ideation section of the C-SSRS) may be included at the discretion of the investigator.
    7. Has insomnia related to RLS (defined as PLM-arousal index of ≥10 PLM-related electroencephalograph (EEG) arousals per hour of sleep for adult subjects or >15 for elderly subjects), sleep breathing disorder (defined as an apnea-hypopnea index ≥10 cumulative apneas and hypopneas per hour of EEG sleep for adult subjects or >15 for elderly subjects), or parasomnias. These disorders will be ruled out by the first PSG recording during Part 2 of screening.
    8a.Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug.
    8b.Is pregnant, or breastfeeding while enrolled in this study or within 1 month after the last dose of study drug

    (Please refer to protocol for additional exclusion criteria)
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in latency to persistent sleep (LPS) as measured by polysomnography (PSG) on Night 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Polysomnography (PSG) during night of day 1 till morning of day 2.
    E.5.2Secondary end point(s)
    1.Change from baseline in wake after sleep onset (WASO) over the first 6 hours as measured by PSG on Night 1.
    2.Change from baseline in PSG parameters
    including: LPS on Night 13, WASO over the first 6 hours on Night 13, Total sleep time (TST) (over 6 and 8 hours) on Nights 1 and 13, Sleep efficiency (SE) on Nights 1 and 13 and other secondary PSG sleep parameters (detailed in Section 9.2.1)on Nights 1 and 13
    3. Patient-reported measures including: Change from baseline in subjective sleep parameters as measured by the Consensus Sleep Diary – Morning Administration (CSD-M), in the morning on Days 2 and 14. Change from baseline in sleep disturbance and impairment as measured by the National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) short form 8a for Sleep Disturbance (PROMIS-SD) and PROMIS short form 8a for Sleep Related Impairment (PROMIS-SRI) on Days 8 and 14. Change from baseline in subject's assessment of insomnia severity using the Patient Global Impression – Severity (PGI-S) scale and
    subject's assessment of improvement in insomnia using the Patient Global Impression – Improvement (PGI-I) scale on Day 14.
    4. Proportion of responders, defined as a ≥50% reduction from baseline in total score on the Insomnia Severity Index (ISI) on Day 14. Proportion of subjects with remission of insomnia symptoms, defined as a total score ≤10 on the ISI on Day 14.
    5. Change from baseline in clinician's assessment of insomnia severity using the Clinical Global Impression – Severity (CGI-S) and improvement in insomnia using the Clinical Global Impression – Improvement (CGI-I) on Day 14.
    6. Safety assessments including: Adverse events (AEs), Proportion of all serious AEs (SAEs) and events of special interest (e.g., falls, parasomnias), Vital signs, physical examinations, electrocardiogram (ECG), laboratory parameters and Columbia Suicide Severity Rating Scale (C-SSRS).
    Residual effects as measured by: The presence of next day subjective residual effects as measured by the Karolinska Sleepiness Scale (KSS) on Days 2 and 14. Postural stability (body sway) as measured with an ataxiameter on Days 2 and 14 in the morning and on Day 15 at 4-hours post night 14 dose (middle of the night awakening).

    (Please refer to protocol for additional secondary endpoints)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time point(s) stated above in E.5.2
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Japan
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 360
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The study investigator must ensure the patient is appropriately transitioned and/or followed for any additional care required. Patients should continue with their standard of care after the end of the study per investigator's or the treating physician's clinical judgement. This should be planned for in advance of each patient's completion of the study and based on their individual clinical needs.
    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 Decision2018-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-27
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