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    Summary
    EudraCT Number:2015-003198-14
    Sponsor's Protocol Code Number:VP-VEC-162-3106
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-10-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-003198-14
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of multiple oral doses of tasimelteon and matching placebo in travelers with Jet Lag Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of multiple oral doses of tasimelteon and matching placebo in travelers with Jet Lag Disorder
    A.3.2Name or abbreviated title of the trial where available
    VP-VEC-162-3106 Tasimelteon in travellers with jet lag disorder
    A.4.1Sponsor's protocol code numberVP-VEC-162-3106
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVanda Pharmaceuticals 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 supportVanda Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace UK
    B.5.2Functional name of contact pointSenior Director
    B.5.3 Address:
    B.5.3.1Street Address26-28 Hammersmith Grove
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW6 7HA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208 563 5902 5702
    B.5.5Fax number+44 208 741 6496
    B.5.6E-mailA.Masih@Medpace.com
    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 Yes
    D.2.1.1.1Trade name HELTLIOZ®
    D.2.1.1.2Name of the Marketing Authorisation holderVanda Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/841
    D.3 Description of the IMP
    D.3.1Product nameTasimelteon (HELTLIOZ®)
    D.3.2Product code VEC-162
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboCapsule
    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
    E.1.1.1Medical condition in easily understood language
    Jet Lag Disorder (JLD)
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10040984
    E.1.2Term Sleep disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the effects of tasimelteon 20 mg on nighttime sleep parameters as measured by Polysomnography (PSG) after transmeridian travel on the worst night.
    - Step-down Primary: To assess the effects of tasimelteon 20 mg as measured by the reduction in the proportion of patients with disturbed sleep after transmeridian travel on the worst night
    E.2.2Secondary objectives of the trial
    Key secondary objectives:
    1. To evaluate tasimelteon 20 mg for treatment of excessive daytime sleepiness associated with Jet Lag Disorder due to transmeridian travel as measured by Maintenance of Wakefulness Test (MWT).
    2. To assess the effects of tasimelteon 20 mg on subjective assessments of daytime sleepiness as measured by the Karolinska Sleepiness Scale (KSS) on the worst day.
    3. To assess the effects of tasimelteon 20 mg on objective assessments of Latency to Persistent Sleep (LPS) on the worst night.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability and acceptance to provide written informed consent
    2. Men or women between 18 – 75 years, inclusive
    3. Body Mass Index (BMI) of ≥ 18 and ≤ 30 kg/m2 (BMI = weight (kg)/ [height (m)]2)
    4. Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control (i.e., condoms, diaphragm, spermicidal agents, cervical cap) for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline and D1 visits;
    5. Note: Women using hormonal methods of birth control must use an additional method of birth control during the study and for one month after the last dose. Valid passport for international travel and fluent in English
    6. In good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology
    7. Willing to comply with study procedures and restrictions with fixed sleep time and wake time during the study and to attend regularly scheduled clinic visits as specified in this protocol
    8. Has negative urine test result for selected substances of abuse at V2- through the end of the randomization phase
    9. Has not used pharmacological sleep assistance more than 4 times/month during the 3 months prior to screening
    10. Must have discontinued use of all pharmacological sleep aids beginning 1 week prior to Visit 2 and for the duration of the trial
    11. Must have a target daily bedtime that on average occurs between 21:00 and 24:00
    12. History of sleep disturbances associated with jet lag symptoms at least once in the last five years, as defined in the International Classification of Sleep Disorders (ICSD-3)
    13. Must have ≤60% Sleep Efficiency during the first two thirds of the 8-hour sleep period after a 5-8 hour phase advance of their sleep-wake schedule conducted during a diagnostic PSG while in screening
    14. Actigraphy must demonstrate, on average, that the total sleep time each night is between 7 to 9 hours during screening
    15. Actigraphy must demonstrate, on average, the subject’s habitual bedtime does not differ by more than 2 hours during screening
    E.4Principal exclusion criteria
    1. History of primary insomnia or any circadian rhythm sleep disorder, other than jet lag, as defined by ICSD-3
    2. History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures
    3. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable
    4. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists
    5. Indication of impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) or bilirubin > Upper Limit of Normal)
    6. Clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings at screening or baseline as determined by the clinical investigator
    7. Major surgery, trauma (including broken pelvis/legs), illness (e.g. sepsis, stroke) or immobile for 3 or more days within the past month
    8. Current smoker or quit smoking within the last 30 days
    9. Active cancer or cancer treatment within the past 6 months
    10. Central venous catheter in place or within the past month
    11. History of pulmonary embolism /deep vein thrombosis (DVT) or short term blood thinner treatment as an outpatient (e.g. Coumadin, Lovenox, heparin)
    12. History or family history of thrombosis or hypercoagulable state (e.g. Factor V Leiden, Factor VIII deficiency, Protein C & S deficiency)
    13. Pregnancy or recent pregnancy (within 6 weeks)
    14. History of restless leg syndrome, sleep apnea, or periodic limb movement disorder and or have current diagnosis as confirmed by the diagnostic PSG at V2
    15. Habitual bedtime varies by more than two hours, on average
    16. History or evidence of excessive daytime sleepiness as determined by a score of more than 10 on the Epworth Sleepiness Scale;
    17. History of drug or alcohol abuse as defined in DSM-V, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening and/or regular consumption of alcoholic drinks (> 2 drinks/day or > 14 drinks/week)
    18. Traveled more than three time zones 2 weeks prior to the screening visit until the travel period.
    19. Traveled outside the origination time zone within 1 week before the end of the screening period.
    20. An average bedtime that varies more than 2 hours per week than the target bedtime during the weeks between the diagnostic PSG and the baseline visit based on patient reported sleep diaries and actigraphy.
    21. Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit.
    22. Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial
    23. Use of any investigational drug, including placebo, central nervous system medication, or any other prescription or OTC medication that affects the sleep-wake cycle within 3 weeks or 5 half-lives (whichever was longer) of Baseline.
    24. Any other sound medical reason as determined by the clinical investigator.
    25. Subjects having suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline.
    26. Subject is at risk of suicide, in the opinion of the Investigator. Evidence of suicide risk could include any suicide attempt within the past year or any other suicidal behavior within the past year.
    27. Unwilling or unable to follow the medication restrictions, or unwilling or unable to sufficiently wash-out from use of a restricted medication
    28. Use of melatonin or melatonin agonist within 1 week of the screening visit until randomization.
    29. Routinely consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 4 cups a day (32 ounces)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as the first two thirds of the night (TST2/3) on the worst of 3 nights of sleep calculated from Total Sleep Time as measured by polysomnography. The primary null hypothesis is that there is no difference in TST2/3 between subjects receiving tasimelteon and subjects receiving placebo. TST2/3 will be assessed by analysis of covariance, with treatment group, clinical site, baseline and time zone as a main effect. The primary efficacy analysis will be based on the ITT population.
    If the primary null hypothesis is rejected at an alpha level of 0.05, then the step-down primary null hypothesis will also be tested at an alpha level of 0.05 to assess the efficacy of tasimelteon versus placebo as measured by the reduction in the proportion of patients with disturbed sleep on the worst night. The step-down primary endpoint will be summarized and analyzed by a two-sided unconditional exact test, Barnard’s exact test. The ITT population will be used in this analysis.
    The Step-down Primary endpoint is to assess the effects of tasimelteon as measured by the reduction in the proportion of patients with disturbed sleep after transmeridian travel on the worst night.
    E.5.2Secondary end point(s)
    The key secondary/secondary efficacy outcomes include:
    • MWT score
    • PGI-S score
    • TSTfn, LPS, SE and WASO as measured by PSG
    • TSTs, SL, SQs as measured by Sleep Diaries KSS score
    • JLQ score
    For the continuous key secondary or secondary efficacy variables, descriptive statistics will be presented by treatment group, and the scores will be summarized and analyzed in a manner similar to that for the primary endpoint. Categorical variables will also be summarized and evaluated. Details of the analysis and the multiplicity adjustment for the key secondary endpoints and analysis will be described in the SAP.
    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 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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Netherlands
    United Kingdom
    United States
    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
    LPLV
    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 days0
    E.8.9.2In all countries concerned by the trial months5
    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 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.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    None
    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 Decision2015-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-02-28
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