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    Summary
    EudraCT Number:2021-005475-40
    Sponsor's Protocol Code Number:VP-VEC-162-3502
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-005475-40
    A.3Full title of the trial
    A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)
    A.4.1Sponsor's protocol code numberVP-VEC-162-3502
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04652882
    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 organisationExperTrials
    B.5.2Functional name of contact pointChristoph Wachter
    B.5.3 Address:
    B.5.3.1Street AddressImmeuble Le Patio – HQ 35/37 Rue Louis Guérin
    B.5.3.2Town/ cityVilleurbanne
    B.5.3.3Post code69100
    B.5.3.4CountryFrance
    B.5.4Telephone number4369910414754
    B.5.6E-mailchristoph.wachter@expertrials.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 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 nameTasimelteon
    D.3.2Product code VEC-162
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNTasimelteon
    D.3.9.2Current sponsor codeTasimelteon
    D.3.9.4EV Substance CodeSUB166225
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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, 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
    Delayed Sleep-Wake Phase Disorder (DSWPD)
    E.1.1.1Medical condition in easily understood language
    Delayed Sleep-Wake Phase Disorder (DSWPD)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10041013
    E.1.2Term Sleep-wake schedule disorder
    E.1.2System Organ Class 10029205 - Nervous system 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 a daily single oral dose of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) in participants over a 28-day period, as measured by sleep diary.
    E.2.2Secondary objectives of the trial
    To assess the effects of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) during the treatment phase, as measured by actigraphy.

    To assess the effects of 20 mg tasimelteon compared to placebo on nighttime subjective sleep parameters such as LPS, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by sleep diary.

    To assess the effects of 20 mg tasimelteon compared to placebo on nighttime objective sleep parameters such as LPS, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by actigraphy.

    To assess the effects of 20 mg tasimelteon compared to placebo on subjective sleep-related impairments and subjective sleep disturbances, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability and acceptance to provide written informed consent.
    2. A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD), as per ICSD-3.
    3. Males or females between 18 – 75 years, inclusive.
    4. Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m2 (BMI = weight (kg)/[height (m)]2).
    5. Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or participant is postmenopausal for at least 2 years), or females of childbearing potential using an acceptable method of birth control (abstinence, the use of 2 independent barrier methods, hormonal contraception plus 1 barrier method, or surgically sterilized partner) for a period of 35 days before the first dosing, and agree to continue using these methods during the study, and for one month after the last dose. WOCBP must also have a negative pregnancy test at V1, V2, and V3.
    6. In good health as determined by a medical history, physical examination, ECG, serum chemistry and hematology, and urinalysis.
    7. Willing to comply with study procedures and restrictions with fixed sleep time during the study and to attend regularly scheduled clinic visits as specified in this protocol.
    8. Must have a desired bedtime at least 2 hours earlier than the habitual sleep onset (determined by the DSPD Screening Questionnaire). There must be at least a 2 hour difference between the reported sleep onset, by daily sleep diary, and the desired bedtime (determined by the DSPD Screening Questionnaire), on at least 5 of the 7 days per screening week.
    9. Must have a sleep onset of 00:00 or later (determined by the DSPD Screening Questionnaire).
    10. Must have a reported sleep onset of 00:00 or later by daily sleep diary, on at least 5 of the 7 days per screening week.
    11. Must have 80% compliance for daily sleep diary completion, throughout screening.
    12. Must maintain a reported desired bedtime (± 15 minutes) by daily sleep diary, on at least 5 of the 7 days during the run-in phase.
    13. Must have a reported sleep onset of ≥ 2 hours from the desired bedtime by daily sleep diary, on at least 5 of the 7 days during the run-in phase.
    E.4Principal exclusion criteria
    1. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal, or metabolic dysfunction unless currently controlled and stable.
    2. Acute exacerbation of an existing psychiatric comorbid condition that requires change in treatment or intervention in the 3 months prior to the screening visit.
    3. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists.
    4. Indication of impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) or bilirubin > 2 times the Upper Limit of Normal).
    5. Clinically significant deviation from normal in clinical laboratory results, vital sign measurements, or physical examination findings as determined by the Investigator.
    6. Major surgery, trauma (including broken pelvis/legs), illness (i.e., sepsis, stroke), general anesthesia, or immobility for 3 or more days within 30 days of the screening visit.
    7. Current tobacco user or quit using tobacco within 30 days of the screening visit.
    8. Active cancer or cancer treatment within 6 months of the screening visit.
    9. Central venous catheter in place or within 30 days of the screening visit.
    10. History of pulmonary embolism/deep vein thrombosis (DVT) or short-term blood thinner treatment as an outpatient (i.e., Coumadin, Lovenox, Heparin).
    11. History or family history of thrombosis or hypercoagulable state (i.e., Factor V Leiden, Factor VIII deficiency, Protein C & S deficiency).
    12. Pregnancy, recent pregnancy (within 6 weeks of the screening visit), or females who are breastfeeding.
    13. History of restless leg syndrome, sleep apnea, or periodic limb movement disorder and/or have current diagnosis as confirmed by the screening visit.
    14. History or evidence of sleep apnea as determined by a high-risk score in any two of the three categories in TBQ, unless ruled out by a recent sleep study for sleep apnea.
    15. 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).
    16. A positive test for substances of abuse at the screening visit V2 or V3.
    17. Traveled more than 3 time zones 2 weeks prior to the screening visit.
    18. Traveled outside the origination time zone within 1 week before the screening period and until the end of the treatment period.
    19. Worked regular night shifts in the 2 months leading up to the screening visit.
    20. Randomization in a previous tasimelteon (VEC-162 or BMS-214778) trial.
    21. Use of any investigational drug central nervous system medication, or any other prescription or over-the-counter (OTC) medication that affects the sleep-wake cycle within 3 weeks or 5 half-lives (whichever is longer) of the screening visit.
    22. Participant is at risk of suicide, in the opinion of the Investigator. Evidence of suicide risk could include any suicide attempt or any other suicidal behavior within 12 months of the screening visit or any suicidal ideation of type 4 or 5 on the C-SSRS at V1, V2, or V3.
    23. Unwilling or unable to follow the medication restrictions, or unwilling or unable to sufficiently washout from use of a restricted medication.
    24. Use of melatonin or melatonin agonist within 3 weeks of the screening visit.
    25. Have a reported change of ≥ 2 hours from the average reported sleep onset from screening by daily sleep diary, during the run-in phase.
    26. Any other sound medical reason as determined by the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Sleep onset (change from baseline), as measured by sleep diary.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    • To assess the effects of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) during the treatment phase, as measured by actigraphy.

    • To assess the effects of 20 mg tasimelteon compared to placebo on nighttime subjective sleep parameters such as latency to persistent sleep (LPS), wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by sleep diary.

    • To assess the effects of 20 mg tasimelteon compared to placebo on nighttime objective sleep parameters such as LPS, wake time, midpoint of sleep, and total sleep time (change from baseline), as measured by actigraphy.

    • To assess the effects of 20 mg tasimelteon compared to placebo on subjective sleeprelated impairments and subjective sleep disturbances, as measured by the Patient- Reported Outcomes Measurement Information System (PROMIS).

    • To assess the effects of 20 mg tasimelteon compared to placebo on global improvement and severity, as measured by Clinical Global Impression of Change (CGI-C), Patient Global Impression of Change (PGI-C), and Patient Global Impression of Severity (PGIS).

    • To assess the effects of 20 mg tasimelteon compared to placebo on the change in circadian phase from baseline to post-treatment, as measured by salivary DLMO.

    • To assess the effects of 20 mg tasimelteon on Sleep Onset (change from baseline) in participants with delayed DLMO compared to participants with non-delayed DLMO, as measured by sleep diary.

    • To assess the effects of 20 mg tasimelteon on Sleep Onset (change from baseline) in participants with PER3 rs57875989 (specifically genotype 4/4 and 4/4+4/5), as measured by sleep diary.

    • To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    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 Yes
    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 Yes
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Australia
    United States
    Austria
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 300
    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)
    The purpose of the OLE phase is to explore the long-term safety + efficacy of tasimelteon in participants diagnosed with DSWPD over an additional 11 months. This may allow participants previously randomized to the tasimelteon arm in the treatment phase the opportunity to continue treatment with tasimelteon. For participants previously randomized to the placebo arm, this may afford them the opportunity to explore the potential benefits of a new drug treatment not otherwise available to them.
    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 Decision2022-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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