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    Summary
    EudraCT Number:2015-001463-39
    Sponsor's Protocol Code Number:E2006-G000-303
    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:2016-11-21
    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 number2015-001463-39
    A.3Full title of the trial
    A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel-Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lemborexant for long-term treatment of insomnia disorder in adults
    A.4.1Sponsor's protocol code numberE2006-G000-303
    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 SponsorEisai Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportEisai Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Ltd.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)845 676 1400
    B.5.5Fax number+44(0)845 676 1486
    B.5.6E-mailLMedInfo@eisai.net
    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 namelemborexant
    D.3.2Product code E2006
    D.3.4Pharmaceutical form Tablet
    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 INNlemborexant
    D.3.9.1CAS number 1369764-02-2
    D.3.9.2Current sponsor codeE2006
    D.3.9.4EV Substance CodeSUB177370
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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 namelemborexant
    D.3.2Product code E2006
    D.3.4Pharmaceutical form Tablet
    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 INNlemborexant
    D.3.9.1CAS number 1369764-02-2
    D.3.9.2Current sponsor codeE2006
    D.3.9.4EV Substance CodeSUB177370
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Treatment for insomnia disorder
    E.1.1.1Medical condition in easily understood language
    Insomnia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    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
    Determine the efficacy of lemborexant 5 mg (LEM5) and 10 mg (LEM10) compared to placebo (PBO) on subjective sleep onset latency (sSOL) after 6 months of treatment in subjects with insomnia disorder
    E.2.2Secondary objectives of the trial
    Determine the efficacy of LEM5 and LEM10 compared to PBO on subjective sleep efficiency (sSE) after 6 months of treatment in subjects with insomnia disorder

    Determine the efficacy of LEM5 and LEM10 compared to PBO on subjective wake after sleep onset (sWASO) after 6 months of treatment in subjects with insomnia disorder

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age 18 years or older at the time of informed consent
    2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia Disorder, as follows:
    - Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep, difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep
    - Frequency of complaint ≥3 times per week
    - Duration of complaint ≥3 months
    - Associated with complaint of daytime impairment
    3. At Screening: History of sSOL ≥30 minutes on at least 3 nights per week in the previous 4 weeks AND/OR sWASO ≥60 minutes on at least 3 nights per week in the previous 4 weeks
    4. At Screening: Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
    5. At 1st Screening Visit (Visit 1) and 2nd Screening Visit (Visit 2a): Reports regular bedtime, defined as the time the subject attempts to sleep, between 21:00 and 01:00 and regular waketime, defined as the time the subject gets out of bed for the day, between 05:00 and 10:00
    7. At the 2nd Screening Visit (Visit 2a): Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ≥30 minutes on at least 3 of the 7 nights and/or sWASO ≥60 minutes on at least 3 of the 7 nights
    8. At the 2nd Screening Visit (Visit 2a): Confirmation of regular bedtimes and waketimes, as determined from responses on the Sleep Diary completed on a minimum of 7 consecutive mornings between the 1st and 2nd screening visit, such that the subject has a regular time spend in bed, either sleeping or trying to sleep, between 1 and 10 hours
    9. At the 2nd Screening Visit (Visit 2a): Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary completed on 7 mornings between the 1st and 2nd screening visit, such that there are not more than 2 nights with duration of time spent in bed <7 hours or >10 hours
    10. At Baseline (Visit 3a): Reconfirmation of insomnia symptoms, as determined from responses on the Sleep Diary for the final 7 nights of the Run-in Period, such that sSOL ≥30 minutes on at least 3 of the 7 nights and/or sWASO ≥60 minutes on at least 3 of the 7 nights
    11. At Baseline (Visit 3a): Confirmation of regular bedtimes and waketimes such that the subject has a regular time spent in bed, either sleeping or trying to sleep, between7 and 10 hours, for the final 7 nights of the Run-In Period
    12. At Baseline (Visit 3a): Reconfirmation of regular bedtime, defined as the time subject attempts to sleep, between 21:00 and 01:00 and regular waketime, defined as the time the subject gets out of bed for the day, between 05:00 and 10:00, for the final 7 nights of the Run-In period
    13. Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
    14. Willing to not start a behavioral or other treatment program for insomnia during the subject’s participation in the study
    E.4Principal exclusion criteria
    1. A current diagnosis of sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on the SDSB as follows: STOPBang score ≥5, IRLS score ≥16, ESS score >15 (Scores of 11-15 require excessive daytime sleepiness must be recorded in subject's Medical History)
    2. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy
    3. Reports a history of sleep-related violent behavior, or sleep driving, or an other complex sleep-related behavior, eg, making phone calls, or preparing an eating food while asleep
    4. For subjects who underwent diagnostic PSG within 1 year before informed consent: Age 18 to 64 years: Apnea-Hypopnea Index ≥10, or Periodic Limb Movements with Arousal Index ≥10; Age ≥65 years: Apnea-Hypopnea Index >15, or Periodic Limb Movements with Arousal Index >15
    5. Beck Depression Inventory – II (BDI-II) score >19 at Screening
    6. Beck Anxiety Inventory (BAI) score >15 at Screening
    7. Habitually naps more than 3 times per week
    8. Females who are breastfeeding or pregnant at Screening or Study Baseline (as documented by a positive serum beta-human chorionic gonadotropin [ß-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the 1st dose of study drug.
    9. Females of childbearing potential who:
    -Had unprotected sexual intercourse within 30 days before study entry or who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a contraceptive implant, injectable contraceptives, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    10. Excessive caffeine use that in the opinion of the investigator contributes to the subject’s insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study
    16. Current evidence of clinically significant disease (eg, cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; severe hepatic insufficiency; gastrointestinal; renal including severe renal impairment; neurological [including subjects who lack capacity and/or whose cognitive decline indicates disorientation to person/place/ time and/or situation] or psychiatric disease or malignancy within the past 5 years [other than adequately treated basal cell carcinoma]) or chronic pain that in the opinion of the investigator(s) could affect the subject’s safety or interfere with the study assessments. Subjects for whom a sedating drug would be contraindicated for safety reasons because of the subject’s occupation or activities are also excluded.
    17. Comorbid nocturia resulting in frequent need to get out of bed to use the bathroom during the night
    18. Any history of a medical or psychiatric condition that in the opinion of the investigator(s) could affect the subject’s safety or interfere with the study assessments
    19. Any suicidal ideation with intent with or without a plan at Screening or Study Baseline or within 6 months of Study Baseline (ie, answering “Yes” to questions 4 or 5 on the Suicidal Ideation section of the eC-SSRS)
    21. Scheduled for major surgery during the study
    22. Used any prohibited prescription or over-the-counter concomitant medications within 1 week or 5 half lives, whichever is longer, before the 1st dose of study medication (Run-In Period).
    23. Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 1 week or 5 half lives, whichever is longer, before the 1st dose of study medication (Run-In Period)
    24. Failed treatment with suvorexant (efficacy or safety) following treatment with an appropriate dose and of adequate duration in the opinion of the investigator
    26. A positive drug test at Screening, Run-In, or Baseline or unwilling to refrain from use of recreational drugs during the study
    28. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days or 5 times the half-life, whichever is longer preceding informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from Study Baseline in sSOL at Month 6
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Month 6.

    The sSOL change from Study Baseline to Month 6 will be analyzed using the mixed effect model repeated measurement (MMRM) analysis on the FAS. The model will include all data and will be adjusted for the corresponding Study Baseline value, region, age group (<65 years old; ≥65 years old), treatment, time (average of the first 7 nights, Month 1, Month 3, and Month 6) and the interaction of treatment by time.
    E.5.2Secondary end point(s)
    Key Secondary endpoints:
    Mean change from Study Baseline in sSE at Month 6
    Mean change from Study Baseline of sWASO at Month 6

    Additional Secondary Endpoints:

    Mean change from Study Baseline of sSOL, of sSE, of sWASO and of subjective total sleep time (sTST), at the beginning of treatment (mean of the 7 nights after the 1st dose in Period 1), at Month 1 and at Month 3
    Mean change from Study Baseline of sTST at Month 6
    Proportion of responders at Month 6 and Month 12, where sleep onset responder is defined as
    follows: sSOL at Study Baseline is ≥30 minutes and mean sSOL at 6 months is ≤20 minutes, and sleep maintenance responder is defined as follows: sWASO at Study Baseline is ≥60 minutes and mean sWASO at 6 months is ≤60 minutes and shows a reduction of >10 minutes compared to Study Baseline.
    Change from Study Baseline in daytime functioning, assessed as the total score from the 4 items on daytime functioning, on the ISI, at Months 1, 3, and 6
    Change from Study Baseline on the FSS at Months 1, 3, and 6
    Ratings on the morning sleepiness item of the Sleep Diary, for:
    -The mean change from Study Baseline of the 1st 7 mornings after the 1st dose in Period 1 and Period 2
    -The mean change from Study Baseline at: Month 1, Month 3, and Month 6
    -The mean change from Study Baseline and from Period 2 Baseline (as appropriate) for subjects with 1, 3, 6, 9, and 12 months exposure (revised per Amendment 06)
    - The mean change from Screening for the 1st 7 mornings and 2nd 7 mornings of the Follow-up Period
    Rebound insomnia endpoints as assessed from the Sleep Dairy during the Follow-up Period
    - Change from Screening of sSOL on each of the 1st 3 nights, mean sSOL of the 1st 7 nights, and mean sSOL of the 2nd 7 nights of the Follow-up Period
    - Change from Screening of sWASO on each of the 1st 3 nights, mean sWASO of the 1st 7 nights and mean sWASO of the 2nd 7 nights of the Follow-up Period
    - Proportion of subjects whose sSOL is longer than at Screening for each of the 1st 3 nights, or whose mean sSOL is longer than at Screening for 1st 7 nights or 2nd 7 nights of the Follow-up Period
    - Proportion of subjects whose sWASO is higher than at Screening for each of the 1st 3 nights, or whose mean sWASO is higher than at Screening for the 1st 7 nights or 2nd 7 nights of the Follow-up Period

    Persistence of Effect
    - Mean change from Study Baseline of sSOL, of sSE, of sWASO and of sTST at Months 3, 6, 9, and 12 compared to Month 1
    - Mean change from Treatment Period 2 Baseline (Month 6) of sSOL, sSE, sWASO, and sTST at Months 9 and 12 compared to Month 7 (the first month of treatment in Period 2) (revised per Amendment 6)
    - Mean change from Study Baseline and Treatment Period 2 Baseline (as appropriate) of sSOL, sSE, sWASO, and sTST at 3 and 6 months exposure compared to 1 month of exposure (revised per Amendment 06)
    Safety and Tolerability of Lemborexant
    - During Period 1, compared to PBO
    - For subjects exposed to lemborexant for 3, 6, 9, and 12 months (revised per Amendment 6)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Month 6 for the Key Secondary endpoints

    For the other secondary efficacy endpoints (change from Study Baseline of the following for LEM5 and LEM10 compared to PBO; mean sSOL, mean sSE, mean sWASO and mean sTST at 1st 7 nights,
    Months 1 and 3; and mean sTST at Month 6; ISI total of 4 items of daytime functioning at Months 1,
    3, and 6, and FSS score at Months 1, 3, and 6) will be analyzed using MMRM, assuming MAR. The FSS will also be analyzed for responders, including only those subjects who endorsed clinically significant fatigue at Study Baseline (revised per Amendment 03 and 06).
    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 No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Part 2 of the protocol foresees no placebo anymore but comparison between dose levels of test drug
    E.8.2.4Number of treatment arms in the trial3
    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 EEA35
    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
    Canada
    Chile
    Finland
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Poland
    Romania
    Spain
    Taiwan
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    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 state82
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 900
    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)
    None
    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 Decision2016-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-08
    The status of studies in GB is no longer updated from 1.1.2021
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