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    Summary
    EudraCT Number:2006-006677-25
    Sponsor's Protocol Code Number:LTE6672 - SAMS12
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-006677-25
    A.3Full title of the trial
    Efficacy and safety of 2mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a 12-week, multi-center, randomized, double-blind, placebo-controlled study
    A.3.2Name or abbreviated title of the trial where available
    SAMS 12
    A.4.1Sponsor's protocol code numberLTE6672 - SAMS12
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 & de'veloppement
    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 nameVOLINANSERINE
    D.3.2Product code M100907
    D.3.4Pharmaceutical form 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 INNVOLINANSERINE
    D.3.9.1CAS number 139290-65-6
    D.3.9.2Current sponsor codeM100907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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
    Sleep maintenance insomnia (+ subpopulation of stable type II Diabetes Mellitus)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10022437
    E.1.2Term Insomnia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate efficacy of M100907 2 mg/day in comparison to placebo for Sleep Maintenance Insomnia using change from baseline to 12 weeks of patient reported Wake After Sleep Onset (pr-WASO).
    E.2.2Secondary objectives of the trial
    ﾕTo demonstrate efficacy of M100907 in comparison to placebo in improving patientﾒs daytime functioning using change from baseline to 12 weeks in the ﾓGeneral Productivityﾔ Domain score of the Functional Outcomes of Sleep Questionnaire (FOSQ). ﾕSleep: to assess efficacy of M100907 2 mg/d in comparison to placebo as change from baseline to 12 weeks on other parameters of patientﾒs sleep questionnaire. ﾕTo assess clinical safety and tolerability of M100907 2 mg/day in comparison to placebo during the 12 weeks of treatment ﾕTo evaluate subjective next morning residual effects associated with M100907 2 mg/day as compared to placebo at 12 weeks of treatment ﾕTo assess during the one-week run-out period the effect on sleep (pr-WASO, pr-TST), following abrupt discontinuation after 12 weeks of study treatment with M100907 2mg/day in comparison to placebo Sub-population of type II diabetes mellitus with SMI: The objectives in this sub-study
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    *Related to patients: -Out-patients > or equal 18 years of age or the legal age of consent in the area where the study is being done. -Woman of childbearing potential (less than two years post-menopausal or not surgically sterile), must have a negative urine pregnancy test at screening ﾖ and must use a highly effective method of birth control for at least one month prior to screening, which is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs containing hormones, sexual abstinence (unless not acceptable by the local health authorities) or vasectomised partner. *Related to sleep disorders: -Each patient must have primary insomnia based on criteria (DSM IV-TR) with predominant complaints of difficulty in maintaining sleep (nocturnal awakenings or early morning awakenings), 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. -Based on patientﾒs information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 4 or more nights per week over the preceding month. -Based on patientﾒ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. -Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening and randomization visits. To be included patientﾒs answer should be either: 2 (= Somewhat interfering), or 3 (= Much), or 4 (= Very Much Interfering) at both visits. -Based on the information recorded in the patientﾒs sleep questionnaire during the screening week preceding the randomization the following criteria must be present: ﾕ In the Screening Period (5 ﾖ10 days) more than a half (>50%) of nights must have WASO > or equal to 60 min. ﾕ TST < or equal to 7 hours and > or equal to 3 hours on 3-worst screening nights. ﾕ Excluding one night in the Screening Period (5 ﾖ 10 days) with the highest Sleep Onset Latency (SOL) value, the mean SOL for the Screening Period must be < or equal to 30 min. *Related to Type II Diabetes Mellitus -Patients with type II diabetes (WHO definition) must have been on an oral hypoglycemic agent(s) and/or insulin for at least 3 months prior to the Screening Visit (stable regimen for at least one month prior to Screening Visit).</
    E.4Principal exclusion criteria
    *Related to patients: -Females who are lactating or who are pregnant. -Night shift workers, and individuals who nap 3 or more times per week over the preceding month. -Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day. -Participation in another trial having received study medication within one month before the screening visit. -Body mass index > or equal to 33 calculated from patientﾒs height (m) and weight (kg); weight (kg)/height (mﾲ). -Use of any over-the-counter including tryptophan, valerian root (Valeriana officinalis), kava (Piper methysticum Forst), melatonin, St. Johnﾒs Wort (Hypericum perforatum), Alluna (herbal supplement with valerian root) or prescription sleep medication, including hypnotics and sedatives, and anxiolytics, within one week or five half-lives (whichever is longer), prior to screening. -Use of any substance with psychotropic effects or properties known to affect sleep/wake, including, but not limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, within one week or five half-lives (whichever is longer), prior to screening. -Patients unable to complete the study questionnaires. -Patients unwilling to provide written, signed and dated informed consent must not be included in the study. -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. *Related to sleep disorders: -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. *Related to concomitant illnesses: -Patients presenting with acute or chronic pain resulting in insomnia. -Patients with current psychiatric disturbances according to DSM IV 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. -Patients with mental retardation or dementia. -Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions). -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. -Clinically significant and abnormal ECG (including QTcF > or equal to 500ms). -Serious head injury or stroke within the past year. -Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene) at screening. *Related to Diabetes Mellitus Type II -HbA1C level of > or equal to 9.5% at the Screening Visit. -HbA1C level of < or = to 6.5% at the Screening Visit. (Note: diabetic patients with HbA1C level of < or = to 6.5% may be included in the main study population). -Fasting Plasma Glucose > or equal to 250 mg/dL (14.0 mmol/L) at the Screening Visit. -Patients with poorly controlled diabetes; i.e., a history of hospitalization for ketoacidosis within the past 12 months.
    E.5 End points
    E.5.1Primary end point(s)
    ﾕPrimary Endpoint: Change from baseline to 12-week of the mean patient reported WASO derived from patientﾒs sleep questionnaire. ﾕKey secondary endpoint: Change from baseline to 12-week of ﾓGeneral Productivityﾔ domain from Functional Outcomes of Sleep Questionnaire (FOSQ)
    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 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 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) 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
    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 months3
    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 months3
    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.1.3Elderly (>=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 2007-06-08. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 840
    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 Decision2007-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-30
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