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    Summary
    EudraCT Number:2007-002875-15
    Sponsor's Protocol Code Number:TAK-375_107
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-08-30
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-002875-15
    A.3Full title of the trial
    A Single-Center, Randomized, Double-Blind, Double-Dummy Placebo Controlled, Cross-Over Study to Investigate the Next Morning Effects of Ramelteon (8mg), Zopiclone (7.5mg) and Placebo on Actual Driving Performance, Memory Functioning, Psychomotor Performance in Adults with Chronic Insomnia
    A.4.1Sponsor's protocol code numberTAK-375_107
    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 SponsorTakeda
    B.1.3.4CountryUnited Kingdom
    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 nameRamelteon
    D.3.2Product code TAK-375
    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 INNRamelteon
    D.3.9.1CAS number 196597-26-9
    D.3.9.2Current sponsor codeTAK-375
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8mg
    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 type melatonin receptor agonist
    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 Zimovane
    D.2.1.1.2Name of the Marketing Authorisation holderRhone-Poulenc Rorer
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namezopiclone
    D.3.4Pharmaceutical form Capsule, hard
    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 INNzopiclone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 typehypnotics & sedatives – benzodiazepine related drugs
    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, hard
    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 characterised by difficulty with sleep onset
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.0
    E.1.2Level PT
    E.1.2Classification code 10040984
    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
    The primary objective of the study will be to evaluate the impact of ramelteon (8mg), zopiclone (7.5mg), and placebo on driving performance 8.5 to 9.0 hours after bedtime administration in adults with chronic insomnia.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the impact of ramelteon (8mg), zopiclone (7.5mg), and placebo on next-morning memory and psychomotor performance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is male or female and aged 21 to 64 years, inclusive.
    2. A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study. Women NOT of child bearing potential are defined as those who have been surgically sterilized (hysterectomy, oophorectomy, tubal ligation) or who are post-menopausal (defined as at least 2 years since last regular menses). Acceptable methods of contraception are defined in Section 9.1.9 Contraception and Pregnancy Avoidance Procedure.
    3. The subject is capable of understanding and complying with protocol requirements.
    4. The subject signs a written, informed consent form prior to the initiation of any study procedures.
    5. The subject has a body mass index (BMI) between 18 and 34, inclusive.
    6. Based on sleep history, the subject has had chronic insomnia for at least 3 months, as defined by the following:
    a) The predominant complaint is difficulty initiating or maintaining sleep or non-restorative sleep for at least 3 months.
    b) The sleep disturbance (or associated daytime fatigue) causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
    c) The sleep disturbance does not occur exclusively during the course of Narcolepsy, Breathing-Related Sleep Disorder, Circadian Rhythm Sleep Disorder, or a Parasomnia.
    d) The disturbance does not occur exclusively during the course of another mental disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder).
    e) The disturbance is not due to the direct physiological effects of a substance (eg, a drug of abuse, a medication) or a general medical condition.
    7. Based on sleep history, the subject reports a history of sSL ≥60 min.
    8. The subject must complete the PSQ-IVRS questionnaire on at least 5 of the 7 mornings during the single-blind placebo run-in, which will be scheduled between Days -14 and -3.
    9. On at least 3 of the minimum 5 mornings for which PSQ-IVRS has been completed during the single-blind run-in period, the subject must have an sSL of ≥45 minutes as assessed via the PSQ-IVRS.
    10. Based on sleep history, the subject’s habitual bedtime is between 23:00 and 01:00.
    11. The subject is willing to have a fixed bedtime and agrees to go to bed within 30 minutes of the habitual bedtime during the entire study.
    12. Subjects have consistent access to a touch-tone phone and are willing to complete the PSQ-IVRS within 60 minutes of awakening each morning throughout the Screening outpatient portion of the study.
    13. The subject is willing to remain in bed for at least 6.5 hours each night during the entire study.
    14. Based on sleep history, the subject uses pharmacological assistance to sleep 0 to 4 (maximum allowable) times per week in the last 3 months. Subjects must agree to discontinue the use of all pharmacological sleep aids beginning 1 week prior to the first dose of single-blind study medication and throughout the entire duration of the study.
    15. The subject must have a valid driving licence for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
    16. The subject has normal static binocular acuity, corrected or uncorrected.
    E.4Principal exclusion criteria
    1. The subject has a known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
    2. The subject has a known hypersensitivity to zopiclone or related compounds.
    3. The subject has received any investigational compound within 30 days or 5 half-lives prior to the first dose of single-blind study medication, whichever is longer.
    4. The subject has received ramelteon in a previous clinical study or as a therapeutic agent.
    5. The subject has donated more than 400 mL of blood within the 90 days preceding the beginning of the study.
    6. The subject has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of single-blind study medication.
    7. The subject has flown across greater than 3 time zones within 7 days prior to Screening, or will travel across 2 or more time zones during the course of the study.
    8. The subject has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first night of single-blind study medication.
    9. The subject has a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, severe COPD, fibromyalgia.
    10. The subject has a history of psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months.
    11. The subject has a history of drug addiction or drug abuse within the past 12 months as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised (DSM-IV-TR).
    12. The subject has a history of alcohol abuse within the past 12 months, as defined in DSM-IV-TR, or regularly consumes more than 21 alcoholic units per week, and does not agree to abstain from consuming any alcoholic drinks within 24 hours of all inpatient visits.
    13. The subject has a current significant neurological (including cognitive and psychiatric disorder), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
    14. The subject uses tobacco products (including nicotine gum and patch) or any other products during nightly awakenings that may interfere with the sleep wake cycle.
    15. The subject has a positive urine drug screen at the Screening Visit or breathalyzer test at Visit 4.
    NOTE: Subjects with positive urine drug screen for legal substances at Screening, or a positive breathalyzer test at Visit 4, where a washout is possible must be approved by both the sponsor and the principal investigator.
    16. Subjects who exhibit a placebo response during single-blind placebo run in period. A placebo response is defined as those subjects that have an average change in sSL >20 minutes as calculated from the reported PSQ/ IVRS information [Appendix H].
    17. The subject has used any central nervous system medication, melatonin or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
    18. The subject intends to continue taking any disallowed medication or any prescription medication or over-the-counter (OTC) medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication. The subject must report all prescription and OTC medications taken in the 3 weeks prior to Screening.
    19. The subject has any clinically important abnormal finding as determined by a medical history, physical examination, ECG, or clinical laboratory tests, as determined by the investigator. Subjects with clinically significant abnormal laboratory values being considered for the study must be approved by both the Sponsor or its designee and the principal investigator.
    20. The subject has any additional condition(s) that in the investigator’s opinion would: (a) affect sleep/wake function, (b) prohibit the subject from completing the study, or (c) not be in the best interests of the subject to complete the study.
    21. The subject has a positive hepatitis panel, including hepatitis B surface antigen or antibody to hepatitis C virus.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    The primary endpoint for this study is the impact on driving performance at 8.5 to 9.0 hours after bedtime dosing as measured by the SDLP (cm) in driving tests conducted on the morning of each treatment visit.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    To investigate next morning effects on actual driving performance, memory functioning & psychomotor
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    randomised double blind cross over study with single blind run in
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    zopiclone
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    End of trial will consist of a follow-up contact by telephone 7 days after the last dose of study medication.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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) 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 Yes
    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 2007-08-30. Yes
    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 state30
    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)
    Subjects will be referrred back to their sleep physician
    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 Decision2007-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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