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    Summary
    EudraCT Number:2008-003791-22
    Sponsor's Protocol Code Number:EFC10844
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-06
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2008-003791-22
    A.3Full title of the trial
    Efficacy and safety of eplivanserin 5mg/day in insomnia characterized by sleep maintenance difficulties: a 6-week, randomized, double-blind, placebo-controlled, polysomnography study
    A.3.2Name or abbreviated title of the trial where available
    ECLIPSE
    A.4.1Sponsor's protocol code numberEFC10844
    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 & 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.3.8INN - 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    insomnia characterized by sleep maintenance difficulties
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.0
    E.1.2Level LLT
    E.1.2Classification code 10027590
    E.1.2Term <Manually entered code. Term in E.1.1>
    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 the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography
    Number of Awakenings (PSG-NAW).
    E.2.2Secondary objectives of the trial
    •To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings and reported by patients
    •To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo
    •To evaluate the effect of eplivanserin 5mg/day on daytime functioning, as compared with placebo after 6 weeks of treatment
    •To evaluate patient’s impression of treatment effects
    •To evaluate the potential for next-day residual effects with eplivanserin 5mg/day as compared to placebo
    •To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo
    •To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia
    •To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written, signed and dated informed consent obtained.
    2. Primary insomnia based on DSM-IV-TR with difficulty initiating or maintaining sleep, 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.
    E.4Principal exclusion criteria
    1. Based on patient’s information, the patient has spent less than 6.5 hours or more than 9.0 hours, in bed, each night, over the preceding two weeks
    2. Based on patient’s information, the patient complains of less than 1 hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
    3. Patient responds to question 3 of Insomnia Severity Index at screening visit and randomization visit either: 0 (=Not at all interfering), or 1 (=A little interfering).
    4. Mean screening PSG-WASO: calculated on SN1 and SN2 < 45mn, or a screening night with PSG-WASO < 30mn
    5. Mean screening PSG-Total Sleep Time: calculated on SN1 and SN2 ≥7 hours or ≤3 hours
    6. Mean screening PSG-Latency to Persistent Sleep: calculated on SN1 and SN2 > 30mn
    7. Patients under 18 years of age
    8. In-patients
    9. Patients presenting with acute or chronic pain resulting in insomnia
    10. Patients with current psychiatric disturbances according to DSM-IV-TR 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
    11. Body mass index >32 calculated from patient’s height (m) and weight (kg); weight (kg)/square height (m²)
    12. Patients with mental retardation or dementia
    13. Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions)
    14. 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
    15. Clinically significant and abnormal ECG (including QTcF ≥500ms)
    16. Serious head injury or stroke within the past year
    17. Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene), at screening
    18. Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses/day
    19. Use of any over-the-counter including tryptophan, valerian root, kava, melatonin, St John’s Wort, Alluna (herbal sleep supplement with valerian root) or prescription sleep medication, including hypnotics and sedatives (N05C), and anxiolytics (N05B), within 1 week or five half-lives (whichever is longer), prior to screening
    20. 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), antihistamines (R06A), stimulants (N06B) antidepressants (N06A), clonidine, within one week or five half-lives (whichever is longer), prior to screening
    21. Previous participation in a clinical trial (i.e., randomization) with eplivanserin
    22. Participation in any other trial within 1 month before the screening visit
    23. Patients unable to complete the study questionnaire
    24. Patients who are unable to participate for the entire duration of the study, or in the opinion of the investigator, are likely to be non-compliant with the obligations inherent in the trial participation
    25. Patient not able to understand and follow the requirements of the study and to comply
    26. Night shift workers, and individuals who nap 3 or more times per week over the preceding month
    27. Based on medical history and /or PSG: (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep disorder (apnea-hypopnea index >10/hours of sleep), (iv) circadian rhythm sleep disorder, (v) parasomnia (e.g. somnambulism), (vi) dyssomnia not otherwise specified, i.e. periodic leg movement syndrome (A leg movement is defined as a burst of anterior tibialis muscle activity with a duration between onset and resolution of 0.5-5.0 seconds, with an amplitude of at least 25% of the baseline amplitude. The leg movement must be separated from a subsequent leg movement by at least 5 sec and not more than 90 seconds. The leg movement must be associated with an arousal or awakening to be considered an event, and the arousal/awakening must follow the leg movement onset by not more than 3 seconds. Periodic leg movement exclusion criteria are defined as a PLMAI ≥10 events/hours of sleep. Leg movements associated with “wake” and “respiratory events” are not counted)
    28. Severe respiratory and/or severe hepatic insufficiency
    29. Lifetime history of diverticulitis/sigmoiditis
    30. Females who are lactating or who are pregnant
    31. Woman of childbearing potential (less than two years post-menopausal or not surgically sterile), with a positive urine beta-human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
    E.5 End points
    E.5.1Primary end point(s)
    •Change from baseline of mean PSG-WASO on N41/N42.
    •Change from baseline of mean PSG-NAW on N41/N42.
    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 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.8.4.1Number 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 EEA28
    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
    last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 600
    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 Decision2009-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-05
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