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    Summary
    EudraCT Number:2007-003822-28
    Sponsor's Protocol Code Number:EFC10480
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-22
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2007-003822-28
    A.3Full title of the trial
    Comparison of the safety and efficacy of eplivanserin and lormetazepam in the treatment of insomnia characterized by sleep maintenance difficulties. A 4 week, randomized, double-blind, comparative, parallel-group study.
    A.4.1Sponsor's protocol code numberEFC10480
    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 Sponsorsanofi-aventis recherche et développement
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEplivanserin
    D.3.2Product code SR46349
    D.3.4Pharmaceutical form Film-coated 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.3.9.1CAS number 130580-02-8
    D.3.9.2Current sponsor codeSR46349 B
    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) 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 No
    D.IMP: 2
    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 Noctamide
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Sante
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Capsule*
    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 INNLormetazepam
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Chronic primary insomnia and sleep maintenance difficulties.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient’s sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.
    E.2.2Secondary objectives of the trial
    • To compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation.
    • To compare the efficacy of both products on subjective sleep parameters (patient reported (pr)-Wake time After Sleep Onset (WASO), pr-Total Sleep Time (TST), pr-Number of Awakenings (NAW), pr-Sleep Onset Latency (SOL), Quality of Sleep (QoS), refreshing QoS).
    • To compare the effects of both products on patient’s daytime functioning using the Functional Outcome Sleep Questionnaire (FOSQ) and the Sleep Impact Scale (SIS) after 4 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Outpatients, aged 18 years and above.
    • Primary Insomnia according to DSM-IV-TR criteria.
    • Based on patient’s information, the patient must have complained of at least 1 hour of wakefulness for at least 3 nights per week during the preceding month.
    • Based on patient’s information, the patient must have spent at least 6.5 hours and not more than 9 hours in bed (time in bed = TIB) trying to sleep, each night during the preceding 2 weeks.
    • Based on patient’s sleep questionnaire administered each morning during the run-in period, patients must have had the following (calculated on at least 4 nights):
    - a mean pr-WASO ≥ 45 min,
    - a mean pr-TST < 7 hours and > 3 hours,
    - a mean pr-SOL ≤ 30 min.
    E.4Principal exclusion criteria
    • Exclusion criteria related to study methodology
    - Refusal or inability to give written, signed and dated informed consent to participate in the study.
    - Women of childbearing potential (less than 2 years of postmenopausal or not surgically sterile) without a negative urine β-hCG test prior to entry into the study and who do not employ an acceptable method of birth control for this study for one month prior to entry into the run-in, throughout the study, and one month after study medication administration is stopped. Acceptable methods are the following: IUDs, depot, implant and trans-dermal estrogens-progesterones alone, sterilization, and double barrier methods in conjunction with spermicide alone or added to oral contraceptives, sexual abstinence.
    - Females who are pregnant or breastfeeding.
    - Night shift workers and individuals who nap 3 or more times per week over the preceding month (a nap being defined by an intentional sleep of more than 20 minutes).
    - Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day.
    - Patient unable to participate for the entire duration of the study or unable to complete study questionnaires or, in the opinion of the investigator has the potential to be non compliant with the obligations inherent in trial participation.
    - Participation in another clinical trial within 1 month before the screening visit.
    - Based on medical history and patient’s information: primary hypersomnia, narcolepsy, breathing related sleep disorders, circadian rhythm sleep disorder, parasomnia (e.g., somnambulism), dyssomnia not otherwise specified (i.e., periodic leg movement).
    - Current severe neuropsychiatric disorders (i.e., psychosis, obsessive compulsive disorder, major depression, anxiety disorders, panic disorders, dementia of Alzheimer’s or vascular type) according to DSM-IV-TR criteria or mental retardation.
    - Insomnia secondary to a general medical condition.
    - Substance dependence or substance abuse within the last year (except nicotine, DSM-IV-TR criteria).
    - Acute or unstable chronic disease that in the opinion of the Investigator, would compromise the patient’s safety or successful participation in the study or that might interfere with the evaluation of study medication.
    - Evidence of any significant laboratory or ECG finding at screening which the investigator judges incompatible with the investigation of a new chemical entity.
    - Use of any over-the-counter (OTC) medications (including tryptophan, valerian, kava-kava, melatonin and St John’s Wort) or prescription sleep medications including hypnotics and sedatives (N05C) and anxiolytics (N05B) within 1 week or 5 half-lives (whichever is longer) before screening.
    - Use of any substance with psychotropic effects or properties known to affect sleep/wake, including but not limited to: antipsychotics (N05A), morphine/opioid derivatives (N02A), antihistaminics (R06A), stimulants (N06B), antidepressants (N06A), clonidine, within 1 week or 5 half-lives (whichever is longer) before screening.
    • Exclusion criteria related to lormetazepam
    - Certain muscular disorders (i.e.; myasthenia gravis).
    - Narrow angle glaucoma.
    - Hypersensitivity to benzodiazepines.
    - Sleep apnea syndrome.
    • Exclusion criteria related to eplivanserin
    - Severe respiratory and/or severe hepatic insufficiency
    E.5 End points
    E.5.1Primary end point(s)
    • Sleepiness in the morning measured on a visual analog scale of the patient’s sleep questionnaire. (“Do you feel sleepy this morning?”, 100 mm-VAS: very sleepy – not at all sleepy).
    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 No
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 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
    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 months2
    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 months2
    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 Information not present in EudraCT
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 317
    F.4.2.2In the whole clinical trial 382
    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 Decision2008-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-06
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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