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    Summary
    EudraCT Number:2007-004640-78
    Sponsor's Protocol Code Number:ITI-007-004
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-09-25
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2007-004640-78
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, 4-way crossover study of ITI-007 in subjects with sleep maintenance insomnia
    A.4.1Sponsor's protocol code numberITI-007-004
    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 SponsorIntra-Cellular Therapies, Inc
    B.1.3.4CountryUnited States
    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.3.2Product code ITI-007
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.9.2Current sponsor codeITI-007
    D.3.9.3Other descriptive nameIC200056 tosylate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Yes
    D.3.11.13.1Other medicinal product typeit is a chemical product from synthetic route
    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 placeboOral solution
    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 disorders
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10040984
    E.1.2Term Sleep disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of oral administration of ITI-007 on slow wave sleep (SWS) time as determined by polysomnography (PSG) in subjects with sleep maintenance insomnia.
    E.2.2Secondary objectives of the trial
     To determine the effect of oral administration of ITI-007 on objective wake time after sleep onset (WASO) as determined by polysomnography (PSG) in subjects with sleep maintenance insomnia.
     To determine the effect of oral administration of ITI-007 on other objective sleep parameters, total sleep time (TST), number of awakenings (NAW), sleep efficiency index (SEI), number of stage shifts (NSS), duration and proportion of each sleep stage, latency to rapid eye movement (REM) sleep, non-rapid eye movement (NREM) sleep, and time to persistent sleep (LPS) as determined by polysomnography (PSG) in subjects with sleep maintenance insomnia.
     To determine the effect of oral administration of ITI-007 on daytime functioning as assessed by the Digit Symbol Substitution Test (DSST), the Leeds Psychomotor tests (multiple choice reaction time test and the critical fusion frequency test) and the Bond-Lader Visual Analogue scale measuring alertness, contentedness and calmness.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Males aged 18 to 65 years, inclusive,
     Females aged 18 to 65 inclusive, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year post-menopausal),
     based on subject information, the patient has spent at least 6.5 hours and not more than 9.0 hours in bed, each night, with no more than 2 hour variability in 5 out of 7 nights over the preceding 2 weeks,
     subjects must be experiencing at least one hour of wakefulness after sleep onset at least 3 nights per week over the preceding month with a subjective total sleep time of 6.5 hours or less,
     subjects must report an impact associated with sleep maintenance insomnia, as measured by a score of at least at 2 or higher on at least one of the Questions # 2, 3, 4, or 5 of the Insomnia Severity Index (with the whole scale being administered to define baseline insomnia),
     subjects must report a usual bedtime of between 9 pm and midnight,
     subjects must have a body-mass index (BMI) between >19 and <34 kg/m2,
     subjects must be able to give informed consent,
     screening polysomnography criteria: PSG WASO > 45 min, PSG TST between 4 and 7 hours, inclusive, based on screening/baseline PSG criteria,
     subjects must be affiliated with, or beneficiary of, a French social security system.
    E.4Principal exclusion criteria
     likely allergy or sensitivity to ITI-007 based on known allergies to drugs of the same class, or which in the opinion of the Investigator, suggests an increased potential for an adverse hypersensitivity to ITI-007,
     females who are lactating/breast feeding or who are pregnant, or of child bearing potential,
     history of drug or alcohol dependence within 12 months of study start or a positive screening test for alcohol (breathalyzer) or positive urine drug screen,
     history or current diagnosis of primary hypersomnia, restless leg syndrome, periodic leg movements with arousals (PLMA), narcolepsy, rapid eye movement (REM) motor dysfunction disorder, circadian rhythm sleep disorder, breathing related sleep disorder, or parasomnias,
     history or current diagnosis of stroke, head trauma, seizure disorder, or other neurological disorder considered clinically relevant,
     subjects with current diagnosis and treatment of Axis I psychiatric disorder (for example, schizophrenia, mood disorders, anxiety disorders, eating disorders, etc) other than insomnia,
     subjects with acute or chronic pain resulting in insomnia,
     shift work and/or recent significant travel across three or more time zones within the prior 2 weeks,
     napping 3 or more times during the day or self reported napping of >45 min per day,
     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,
     a positive test for hepatitis B (HBs antigens),C (HCV antibodies), or HIV,
     consumption of xanthine –containing beverages (e.g., tea, coffee, or caffeine containing soft drinks) comprising usually more than 5 cups/glasses or > 1 liter per day,
     clinically significant and abnormal ECG (including prolonged QTcB > 450 msec male and > 470 msec female),
     any clinically significant abnormality in laboratory examinations, or vital signs performed at screening,
     smoking more than 10 cigarettes (or equivalent) per day,
     use of any of the following medications within the prior two weeks of screening: benzodiazepines, zolpidem, (es)zopiclone, modafinil, gabapentin, gaboxadol, mianserin, mirtazepine, cyproheptadine, ramelteon, herbal preparations (e.g., St. John’s Wort, valerian root, and kava kava), over the counter sleep preparations (e.g., antihistamines, decongestants, and anticholinergics), or melatonin,
     use of any investigational drug within 90 days prior to study entry or participation in a previous study with ITI-007,
     history of blood donation (> = 500 ml) within 90 days prior to study entry,
     PSG TST < 4 hours or > 7 hours, PSG WASO < = 45 minutes each night, Apnea-hypopnea index (AHI) > 10 or periodic leg movements with arousals index (PLMAI) > 15, based on screening/baseline PSG criteria,
     any subject judged by the principal investigator (PI) to be inappropriate for the study,
     any subject being in the exclusion related to participation in investigational drug studies according to the French National File for Healthy Subjects (total annual amount higher than 4500 Euros).
    E.5 End points
    E.5.1Primary end point(s)
    to reach the 36 completers.
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    EEG study
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state36
    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 Decision2007-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-11
    P. End of Trial
    P.End of Trial StatusOngoing
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