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    Summary
    EudraCT Number:2005-003080-23
    Sponsor's Protocol Code Number:LTE6217
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-003080-23
    A.3Full title of the trial
    Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study
    A.3.2Name or abbreviated title of the trial where available
    GEMS
    A.4.1Sponsor's protocol code numberLTE6217
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 & DEVELOPPEMENT
    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 Information not present in EudraCT
    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 SR46349B
    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.3.8INN - Proposed INNEplivanserin
    D.3.9.1CAS number 130580-02-8
    D.3.9.2Current sponsor codeSR46349B
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sleep maintenance insomnia
    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 assess efficacy of eplivanserin 5mg/day in comparison to placebo after 6 and 12 weeks of treatment on Sleep Maintenance Insomnia using patient sleep questionnaires (pr-WASO).
    E.2.2Secondary objectives of the trial
    - To evaluate patient’s daytime functioning using the Functional Outcomes of Sleep
    Questionnaire (FOSQ) “General Productivity” domain with eplivanserin 5mg/day as compared to placebo after 6 and 12 weeks of treatment.

    - To evaluate residual effects (using patient’s morning questionnaire) that may be associated with eplivanserin 5mg/day as compared to placebo during double-blind treatment period (after each night of treatment).

    - To compare the effect on sleep following abrupt discontinuation (after 12 weeks) between eplivanserin 5mg/day and placebo (during runout period).

    - To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo

    - To document eplivanserin and the main metabolite SR141342 plasma concentrations.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Out- patients,

    2) Age ≥18 years old,

    3) Each patient must have primary insomnia based on criteria (DSM-IV-TR) with
    predominant complaints of difficulty in initiating or maintaining sleep (nocturnal
    awakenings), or nonrestorative sleep for at least one month preceding the study visit, and having clinically significant distress or impairment in social occupational or other important areas of functioning,

    4) Based on patient’s information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks,

    5) Based on patient’ s information, the patient must complain of at least one hour of
    wakefulness after sleep onset for at least 3 nights per week over the preceding month,

    6) Patient must report impact daytime functioning associated with sleep maintenance
    insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit. To be included patient’s answer should be either: 2 (=Somewhat interfering), or 3 (=Much), or 4 (=Very Much Interfering),

    7) Based on the information recorded in the patient’s diary during the screening week preceding the randomization the following criteria must be present:
    a) Mean WASO per night ≥60mn during screening period (7 days) and no period of
    WASO < 45mn on each screening night. However, two nights with WASO < 45min during screening period are acceptable. In addition, two lowest WASO values will be excluded from the calculation of the mean WASO.
    b) TST ≤ 7 hours and ≥ 3 hours on 3-worst screening nights.
    c) Mean SOL per night have to be ≤ 30mn during the screening period. One highest
    SOL value will be excluded from the calculation of mean SOL.
    E.4Principal exclusion criteria
    • Related to study methodology:
    1) Lactating or pregnant women
    2) Woman of childbearing potential (less than two years post-menopausal or not
    surgically sterile), with a positive serum beta-human chorionic gonadotropin (βHCG) pregnancy test at screening and not using an acceptable form of contraception (e.g, birth control pill, intra-uterine device, injection of Depo-ProveraTM, double-barrier method, abstinence),
    3) Patients presenting with acute or chronic pain resulting in insomnia
    4) Patients with current psychiatric disturbances according to DSM-IV-TR- Axis I
    criteria including but not limited to psychosis and /or bipolar disorder, obsessive
    compulsive disorder, major depression, anxiety disorders, panic disorders, eating
    disorder, alcohol or substance abuse or dependence –except nicotine-, or a history
    of lifetime psychosis and /or bipolar disorder,
    5) Body mass index >32 calculated from patient’s height (m) and weight (kg); weight
    (kg)/height (m2),
    6) Patients with mental retardation or dementia,
    7) Patients with a history of epilepsy or seizures (not including benign neonatal and
    childhood convulsions),
    8) Evidence of any clinically significant, severe or unstable, acute or chronically
    progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety,
    9) Clinically significant and abnormal ECG (including QTc≥ 500ms),
    10) A positive test for hepatitis B (HBs antigens) or C (HCV antibodies),
    11) Serious head injury or stroke within the past year,
    12) Positive qualitative urine drug screen (opiates, cocaine, amphetamine,
    cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone,
    propoxyphene), at screening,
    13) Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day,
    14) Use of any over-the-counter including tryptophan, valerian root (Valeriana
    officinalis), kava (Piper methysticum Forst), melatonin, St John’s Wort
    (Hypericum perforatum), Alluna (herbal sleep supplement with valerian root) or
    prescription sleep medication, including hypnotics and sedatives (N05C), and
    anxiolytics (N05B), within one week or five half-lives (whichever is longer), prior to screening.
    15) Use of any substance with psychotropic effects or properties known to affect
    sleep/wake, including, but not limited to: neuroleptics (N05A), morphine/opioid
    derivatives (N02A), sedative antihistamines (R06A), stimulants (N06B)
    antidepressants (N06A), clonidine, within one week or five half-lives (whichever is
    longer), prior to screening,

    • Related to sleep disorders:
    1) Night shift workers, and individuals who nap 3 or more times per week over the
    preceding month,
    2) History of (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep
    disorder, (iv) circadian rhythm sleep disorder, (v) parasomnia (e.g. somnambulism), (vi) dyssomnia not otherwise specified, i.e. periodic leg movement syndrome.
    E.5 End points
    E.5.1Primary end point(s)
    Wake time after sleep onset using patient's sleep questionnaire (pr-WASO)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Last patient, last visit
    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 months11
    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 months11
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 356
    F.4.2.2In the whole clinical trial 948
    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)
    NA
    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 Decision2006-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-10
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