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    Summary
    EudraCT Number:2008-006345-72
    Sponsor's Protocol Code Number:NKI111364
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-006345-72
    A.3Full title of the trial
    A 28-Day, Polysomnographic and Subjective Assessment of Vestipitant (15mg/day) for the Treatment of Primary Insomnia in Adult Outpatients.
    A.4.1Sponsor's protocol code numberNKI111364
    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 SponsorGlaxoSmithKline Research & Development Ltd
    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 nameVestipitant
    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.3.9.2Current sponsor codeGW597599
    D.3.9.3Other descriptive nameVestipitant
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Information not present in EudraCT
    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 in Adult Outpatients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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 compare the efficacy of oral vestipitant (15mg/day) with placebo after 4 weeks of nightly treatment in adult outpatients diagnosed with primary insomnia, as determined objectively by polysomnography (PSG).
    E.2.2Secondary objectives of the trial
    • To compare the efficacy of vestipitant with placebo over the first 2 days of treatment using PSG.
    • To evaluate maintenance of the hypnotic effect of vestipitant compared with placebo using a subject-completed Post-Sleep Questionnaire (PSQ) administered by an Interactive Voice Response System (IVRS).
    • To compare the efficacy of vestipitant with placebo after 4 weeks using the subject-completed Insomnia Severity Index (ISI).
    • To compare the effects of vestipitant with placebo over the first 2 days of treatment and after 4 weeks of treatment on sleep stage distribution, using PSG.
    • To compare the safety and tolerability of vestipitant with placebo.
    • To compare the effects of vestipitant with placebo over 4 weeks on motor and cognitive functioning in the morning.
    • To evaluate discontinuation symptoms and rebound insomnia using the
    Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ), and PSQ,
    respectively, following 4 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject must be able to read and understand the informed consent form and provide written informed consent, indicating the subject’s understanding of the purpose of the study and willingness to comply with all study procedures described in the protocol, including all sleep-laboratory restrictions and procedures.
    2. Male and female subjects 18 through 64 years of age (inclusive).
    3. Diagnosis of Primary Insomnia, based on Diagnostic and Statistical Manual of Mental Disorders –Text Revision (DSM-IV-TR) criteria 307.42.
    • A complaint of difficulty initiating and maintaining sleep or of non-restorative sleep three or more times per week, for at least the 3 months preceding screening.
    • The sleep disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
    • The disturbance in sleep does not occur exclusively during the course of another sleep disorder or occur exclusively during the course of another mental disorder.
    • Lastly, the disturbance is not due to the direct physiological effects of a substance or general medical condition, such as lung disease, cerebrovascular disease, systemic infectious disease, cancer, chronic pain conditions (e.g. arthritis), endocrine conditions, and degenerative neurological disorders.
    4. The subject’s self-reported sleep history includes at least three months of a usual (i.e. > 3 nights per week) TST of less than 6.0 hours, a sleep onset latency (SOL) of at least 30 minutes and WASO => 60 minutes.
    5. Time in bed between 6.5 and 8.5 hours for least 5 nights per week over the preceding 3 months.
    6. Bed time between 21.00 and 24.00 hours that does not vary by more than +/- 2 hours over the preceding 3 months. Bedtime (lights out) will be confirmed by a one-week diary completed before the first PSG screening session (Visits 2/3).
    7. The sleep variables obtained from the two screening PSG sessions (with single-blinded placebo administration at each night) must fall within the following ranges:
    • TST between 240 and 420 minutes inclusive on both nights
    • Mean LPS of 20 minutes or more, and LPS not < 15 minutes on either night
    • Mean WASO of 60 minutes or more, and WASO not < 45 minutes on either night
    8. A female subject is eligible to participate if she is of:
    • Non-childbearing potential defined as pre-menopausal females with a
    documented tubal ligation or hysterectomy; or postmenopausal defined as 12
    months of spontaneous amenorrhea [in questionable cases a blood sample with
    simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol <
    40 pg/ml (<140 pmol/L) is confirmatory].
    • Child-bearing potential and agrees to use one of the contraception methods
    listed in Section 4.5 in the protocol for an appropriate period of time (as determined by the
    product label or investigator) prior to the start of dosing to sufficiently minimize
    the risk of pregnancy at that point. Female subjects must agree to use
    contraception until 3 days post-last dose.
    9. The subject is in good health as determined by medical and psychiatric history,
    physical examination, ECG, and serum chemistry, hematology, serology, and
    urinanalysis results.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Symptoms/signs that are consistent with any primary sleep disorder other than primary insomnia, e.g. sleep apnea, restless leg syndrome, circadian rhythm disorder.
    2. Any clinically significant Axis I psychiatric disorder other than primary insomnia as defined by DSM-IV-TR.
    3. Subject has a recent history (12 months) of mood or other mental disorders that the investigator regards as accounting for the insomnia.
    4. Subject has a Beck Depression Inventory (Version II) [Beck, 1996] total score of 29 or greater at the Screening Visit (Visit 1) or at Visit 4 (if 2 weeks have elapsed between screening visit and randomization). Patients scoring 17 to 28 must be confirmed to not have major depressive illness to be eligible.
    5. History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence (with the exception of tobacco use) within the past 12 months as defined by DSM-IV-TR.
    6. Positive urine drug screen (i.e. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) at Screening Visit (Visit 1). A repeat test will not be allowed if the result is positive.
    7. Positive alcohol breath test at Screening Visit (Visit 1), i.e. alcohol level greater than 0.015% after subject being told that they must not drink for 8 hours preceding the Screening Visit (Visit 1). A repeat test will not be allowed if the result is positive.
    8. Any history of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (except febrile seizure).
    9. Subjects with an unstable medical disorder or a disorder that would likely interfere with the action, absorption, distribution, metabolism or excretion of vestipitant, may pose a safety concern, or interfere with accurate assessment of efficacy or safety.
    10. Subjects have any screening electrocardiography (ECG) parameter outside of the Sponsor-specified ranges as determined by a central ECG reader (See Appendix 2: ECG Parameters); the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the first screening PSG session (Visit 2).
    11. Subjects have any ECG finding that in the Investigator’s judgement is considered to be clinically significant and not resolved by the first day of screening PSG session (Visit 2) (even if not outside of Sponsor-specified ranges in Appendix 2: ECG Parameters).
    12. Known seropositivity for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
    13. Women having a positive serum HCG pregnancy test at the Screening Visit (Visit 1), a positive urine pregnancy dipstick during the screening PSG session (Visit 2) or at Visit 4 (Randomization), or who are lactating or planning to become pregnant within 14 weeks following the Screening Visit (Visit 1).
    14. Subjects have any screening laboratory value outside of the Sponsor-specified ranges at the Screening Visit (Visit 1) (See Appendix 3: Laboratory Parameters). Testing may be repeated once to see if value returns to within range but any such laboratory abnormality must be resolved by the screening PSG session (Visit 2).
    15. Subjects have any laboratory abnormality that in the Investigator’s judgement is considered to be clinically significant and not resolved by the first day of the screening PSG session (Visit 2) (even if not outside of Sponsor-specified ranges in Appendix 3: Laboratory Parameters).
    16. Subjects who are not euthyroid based on laboratory tests at the screening visit. Subjects maintained on thyroid medication must be euthyroid for a period of at least 6 months prior to the Screening Visit (Visit 1), with no dose changes.
    17. Body mass index of 34 or more at the Screening Visit (Visit 1).
    18. Apnea-hypopnea index of 10 or more on Night 1 screening PSG (Visit 2). Subjects failing Night 1 screening PSG should not be screened on Night 2 (Visit 3).
    19. Periodic limb movements with arousal of 10 or more/hour of sleep on Night 1 screening PSG (Visit 2). Subjects failing Night 1 screening PSG should not be screened on Night 2 (Visit 3).
    20. Nightshift or rotating shift-work within 1 month preceding the Screening Visit (Visit 1) or during the study period.
    21. Planned travel across more than 3 time zones during the study or in the 2 weeks preceding the Screening Visit (Visit 1).
    22. Regular napping, i.e. more than 2 naps per week.
    23. Consumption of beverages or foods containing a total of 300 mg or more per day on average of caffeine or other xanthines (e.g. coffee, cola, tea, chocolate) over the one month preceding the Screening Visit (Visit 1) [Note: 360 mL soda = ~50mg, 210 mL coffee or 60 mL espresso = ~100mg, 210mL tea = ~75mg caffeine].
    View protocol for further exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Wake after sleep onset (WASO) as the mean of PSG recordings obtained on two consecutive nights on Days 27/28.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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) 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 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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA12
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state152
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 152
    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 not receive any additional treatment after completion of the study because the indication being studied is not life threatening and other treatment options are available.
    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 Decision2009-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-21
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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