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    Summary
    EudraCT Number:2009-015773-12
    Sponsor's Protocol Code Number:6096-011
    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:2009-10-23
    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 number2009-015773-12
    A.3Full title of the trial
    A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK 6096 in Patients with Primary Insomnia
    A.4.1Sponsor's protocol code number6096-011
    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 SponsorMerck & Co. 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.3.1Product nameMK-6096
    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.3.9.3Other descriptive nameL-002061532, [(2R,5R)-5-(5-Fluoropyridin-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 No
    D.IMP: 2
    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 nameMK-6096
    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.3.9.3Other descriptive nameL-002061532, [(2R,5R)-5-(5-Fluoropyridin-
    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 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
    Primary insomnia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10036701
    E.1.2Term Primary 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 evaluate the efficacy of MK-6096 compared with placebo in improving sleep efficiency (SE) as measured by polysomnography (PSG) on Night 1 and at the end of 4 weeks of treatment, where SE is defined as 100 times total sleep time (minutes) divided by time in bed (minutes). And, to evaluate the safety and tolerability of MK-6096.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of MK-6096 compared with placebo in improving wake after sleep onset (WASO) as measured by PSG on Night 1 and at the end of 4 weeks of treatment. And, to evaluate the efficacy of MK-6096 compared with placebo in improving latency to persistent sleep (LPS) as measured by PSG on Night 1 and at the end of 4 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female between 18 and < 65 years of age on the day of signing
    informed consent.
    2. Patient has a DSM-IV-TR diagnosis of Primary Insomnia based on the investigator’s judgment and the patient’s sleep history, as assessed on the Sleep
    Diagnostic Interview/Sleep History.
    3. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written
    informed consent.
    4. Patient is able to read, understand and complete questionnaires and diaries, including operation of the eDiary.
    5. Patient has completed at least 6 years of formal education; patient obtains a score
    6th grade level on Reading Subtest of Wide Range Achievement Test Version 4
    (WRAT-4) at screening. For languages other than English, the SPONSOR will
    specify other tests or methods of assessing. NOTE: Patients with any secondary
    education (any formal education beyond 8th grade) do not need to conduct a reading
    assessment.
    6. Patient is in good physical and mental health in the opinion of the investigator.
    7. Patient reports on at least 3 out of 7 nights each week during the 4 weeks prior to
    Visit 1 each of the following:
    7.1. Total sleep time of 6.5 hours;
    7.2. Sleep latency of 30 minutes;
    7.3. 1 hour of wakefulness after sleep onset; and
    7.4. Spending 6.5 to 9 hours nightly in bed.
    8. Patient is willing to stay overnight at a sleep laboratory.
    9. Patient is willing to stay in bed for at least 8 hours each night while at the sleep
    laboratory.
    10. The patient’s regular bedtime is between 9 PM (21:00) and 12 AM (00:00).
    11. During the study, the patient is willing to refrain from napping.
    12. During the study, patient is willing to limit alcohol to 2 drinks a day, at least 3 hours before going to bed on non-PSG visit days, and refrains from drinking alcohol at least 24 hours prior to a PSG visit.
    13. During the study, the patient is willing to limit caffeine consumption to 5 standard
    6-ounce cups of caffeinated beverages a day, or 600 mg caffeine, avoid caffeine
    after 4 PM (16:00) on non-PSG nights, and avoid caffeine after 1 PM (13:00) on PSG
    visits.
    14. A female patient who is of reproductive potential has a serum -hCG level consistent with the nongravid state at Screening Visit 1 and agrees to use acceptable contraception. Acceptable contraception is defined as abstinence (where abstinence is a locally accepted form of contraception) or use of 2 regionally accepted effective non-hormonal forms of contraception including: partner using condom with spermicide or status post vasectomy, and patient using intra-uterine device (IUD), diaphragm with spermicide, contraceptive sponge. Note that if a male partner does not use an effective form of contraception, a female patient MUST use 2 acceptable forms of contraception to satisfy the study requirement.
    15. A female patient that is postmenopausal or status post hysterectomy, bilateral tubal ligation, or bilateral oophorectomy is eligible without requiring the use of
    contraception. Postmenopausal status is defined as age 43 years and (1) no menses
    for > 1 year but < 3 years and confirmed by FSH levels elevated into the
    postmenopausal range, as defined by the designated laboratory, or (2) no menses for at least 3 years.
    16. Patient has latency to persistent sleep (LPS) > 20 minutes during the Screening PSG at Visit 2.
    17. Patient has WASO > 45 minutes during the Screening PSG at Visit 2.
    18. Patient has LPS > 20 minutes on both Screening and Baseline PSG nights.
    19. Patient has a mean WASO 60 minutes on the combined Screening and Baseline
    PSG nights, where neither night is 45 minutes.
    E.4Principal exclusion criteria
    1. If female, patient is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.
    2. Patient is expecting to donate eggs or sperm during the study or within 90 days of
    their last dose of study medication.
    3. Patient has a history or diagnosis of any of following conditions, in the opinion of the investigator:
    3.1. Narcolepsy
    3.2. Idiopathic cataplexy
    3.3. Circadian rhythm sleep disorder
    3.4. Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking
    disorder, and REM behavior disorder
    3.5. Sleep-related breathing disorder (such as central sleep apna syndromes,
    obstructive sleep apnea syndromes, sleep-related hypoventilation/hypoxemic
    syndrome, and other sleep-related breathing disorders)
    3.6. Periodic limb movement disorder
    3.7. Restless legs syndrome
    3.8. Primary hypersomnia
    3.9. Excessive daytime sleepiness (EDS) that is not attributable to primary insomnia
    4. Patient has any history of a neurological disorder in the last 10 years.
    5. Patient has history within the past 6 months prior to the Screening Visit or current
    evidence of unstable or otherwise clinically significant cardiovascular disorder including:
    5.1. acute coronary syndrome
    5.2. unstable angina
    5.3. congestive heart failure
    5.4. cardiogenic syncope
    5.5. cardiomyopathy
    5.6. any symptomatic arrhythmia
    6. Patient has clinically significant AV conduction disturbance, sick sinus syndrome, bradycardia, accessory bypass tract.
    7. Patient has a history or current evidence of long QT syndrome, Torsades de pointe, or a QTcB interval of > 450.
    8. Patient has a screening blood pressure > 150 mmHg systolic or > 90 mmHg diastolic or a pulse rate > 100 beats/min in a sitting position. Blood pressure and pulse measurements exceeding these limits, may be repeated as warranted by the investigator, but values must be within the specified limits for the patient to be eligible for the study.
    9. Patient has any of the following:
    9.1. A lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic
    stress disorder;
    9.2. A psychiatric condition requiring treatment with a prohibited medication; or
    9.3. Other current psychiatric condition that, in the investigator’s opinion, would
    interfere with the patient’s ability to participate in the study.
    10. Patient has evidence of ongoing depression or suicidality.
    11. Patient has a history of substance abuse or dependence.
    12. Patient has a positive screening urine drug screen.
    13. Patient has a history of malignancy 5 years prior to signing informed consent,
    except for adequately treated basal cell or squamous cell skin cancer or in situ
    cervical cancer.
    14. Patient has a history of hypersensitivity or idiosyncratic reaction to more than two chemical classes of drugs, including prescriptions and over-the-counter medications.
    15. Patient has a history or current evidence of any condition, therapy, lab or ECG abnormality, or other circumstances that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study.
    16. Patient has abnormal screening laboratory values per the guidelines below or other clinically significant, unexplained laboratory abnormality:
    Alanine transaminase (SGPT or ALT) > 1.5 times the upper limit of normal (x ULN)
    Aspartate transaminase (SGOT or AST) > 1.5 x ULN
    Total bilirubin > 1.5 x ULN
    Serum creatinine of 2 mg/dL
    17. Patient has a history of transmeridian travel or shift work within the past 2
    weeks or anticipates needing to travel at any time during the study.
    18. Patient has donated blood products or has had phlebotomy of > 300 mL within 8
    weeks of signing informed consent, or intends to donate or receive blood products
    during participation in the study.
    19. Patient has recent history (within the last 3 months) of tobacco use associated with initiation or interruption of sleep or requires a cigarette within 30 minutes of waking in the morning.
    20. Patient consumes the equivalent of > 15 cigarettes a day, and the Primary Investigator confirms that the patient’s sleep disturbance is in part the result of this consumption and the patient is unable to refrain from smoking during the night.
    21. The patient has a Body Mass Index (BMI) > 40 kg/m2.
    22. Patient has an underlying pathology of sleep identified during the screening PSG:
    22.1. An Apnea Hypopnea Index > 10 or
    22.2. >10 periodic leg movements associated with an arousal per hour of sleep.
    23. Patient has a positive alcohol breath test or urine drug screen.
    E.5 End points
    E.5.1Primary end point(s)
    Sleep efficiency (SE) at Night 1 and at the end of 4 weeks of treatment, as derived from total sleep time (TST), based on polysomnography (PSG) results
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 328
    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 Decision2009-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
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