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    Summary
    EudraCT Number:2011-000281-35
    Sponsor's Protocol Code Number:VP-VEC-162-3201
    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:2011-03-02
    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 number2011-000281-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon versus Placebo in Totally Blind Subjects with N24HSWD followed by an OLE Phase
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing 20 mg tasimelteon and placebo in the treatment of blind individuals with no light perception having problems in synchronizing their internal clock with the 24- hour light-dark cycle
    A.4.1Sponsor's protocol code numberVP-VEC-162-3201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01163032
    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 Pharmaceuitcals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVanda Pharmaceuticals Inc.
    B.5.2Functional name of contact pointMarlene Dressmann
    B.5.3 Address:
    B.5.3.1Street Address2200 Pennsylvania Ave NW Suite 300E
    B.5.3.2Town/ cityWashington
    B.5.3.3Post codeDC 20037
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12027343400
    B.5.5Fax number+12022961450
    B.5.6E-mailmarlene.dressman@vandapharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/841
    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.3.9.1CAS number 609799-22-06
    D.3.9.2Current sponsor codeVEC-162
    D.3.9.3Other descriptive name(IR-trans)-N-[[2-(2.3-dihydro-4-benzofurany)cyclopropyl]methyl]propanamide
    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
    Blind males or females with no conscious light perception and the complaint of a sleep-wake disorder associated with Non-24 Hour Sleep-Wake Disorder.
    E.1.1.1Medical condition in easily understood language
    Blind males or females with no conscious light perception and the complaint of a sleep-wake disorder associated with Non-24 Hour Sleep-Wake Disorder.
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10009191
    E.1.2Term Circadian rhythm sleep 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 determine the efficacy of tasimelteon in subjects with N24HSWD as measured by the proportion of entrainment.

    (A step-down objective): To determine the efficacy of tasimelteon in subjects with N24HSWD as measured by the proportion of patients with a clinical response;
    Clinical response is defined as the coincident demonstration of :
    1.) Entrainment of the aMT6s rhythm, and
    2.) A score of ≥3 on the Non-24 Clinical Response Scale (N24CRS)

    The success of the trial will be based on the rejection of the null hypothesis associated with the proportion of entrainment as measured by aMT6s.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives
    • To determine the efficacy of tasimelteon in subjects with N24HSWD as measured by the proportion of responders with a combined sleep/wake response for nighttime sleep duration and daytime sleep duration defined as:
    1. Increase of 90 minutes or greater in LQ-nTST and
    2. Decrease of 90 minutes or greater in UQ-dTSD
    • To determine the efficacy of tasimelteon in subjects with N24HSWD as measured by the proportion of entrainment as assessed by urinary cortisol

    Additional Secondary Objectives: See protocol
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic sub-study
    E.3Principal inclusion criteria
    1. Ability and acceptance to provide informed consent;
    2. Men or women between 18 – 75 years, inclusive;
    3. Body Mass Index (BMI) of ≥ 18 and ≤ 33 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 1 year before screening), or females of child-bearing potential using 2 independent barrier methods 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 at the screening and baseline visits;
    Note: Hormonal contraception is not considered a reliable method of birth control in this study.
    Note: For patients over 55 years of age at the screening visit absence of menses for 1 year before screening is sufficient to establish the postmenopausal status. The postmenopausal status of a patient under 55 years of age at the screening visit will be confirmed by measuring the following hormones:
    Follicle-stimulating hormone (FSH) ≥40 mIU/mL
    Estradiol ≤ 30 pg/mL (110.1 pmol/L)
    5. Willing to comply with study requirements and restrictions including commitment to a fixed 9-hour sleep opportunity during the study;
    6. Fluent in English or German respectively;
    7. No perception of light by the subject’s own report;
    8. Tau length of ≥ 24.25 and the lower bound of 95% CI > 24.0 and the upper bound of 95% CI < 24.9 based on urinary aMT6s rhythms;
    9. Diagnosis of N24HSWD as determined by:
    a. History (within the last 3 months) of trouble sleeping at night (difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and
    b. Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.
    E.4Principal exclusion criteria
    1. Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
    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. Subjects who take NSAIDs daily and would not interrupt their use for the 48-hour urine collections and the 24 hours preceding them;
    4. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
    5. History of drug or alcohol abuse as defined in DSM-IV, 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);
    a. Note: A standard drink is equal to 13.7 grams (0.6 ounces) of pure alcohol or
    o 12-ounces of beer
    o 8-ounces of malt liquor
    o 5-ounces of wine
    o 1.5-ounces or a “shot” of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey);
    6. Subjects having any suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline;
    7. 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;
    8. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
    9. Subjects who have estimated creatinine clearance (CLcr; based on the Cockcroft-Gault equation) ≤ to 55 mL/min;
    10. 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;
    11. Indication of impaired liver function (values for AST, ALT or bilirubin > 2 times Upper Limit of Normal);
    12. Pregnant or lactating females;
    13. A positive test for drugs of abuse at the screening visit;
    Note: A positive drug screen at Visit 1 needs to be discussed with the medical monitor and will be evaluated on a case-by-case basis.
    14. Smoke more than 10 cigarettes/day;
    15. 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 or plan to work these shifts during the study;
    16. Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial;
    17. Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening;
    18. Unwilling or unable to follow the medication restrictions described in Section 8.2., or unwilling or unable to sufficiently wash-out from use of a restricted medication
    19. Use of melatonin or melatonin agonist within 1 week of the tau identification segment;
    20. Unable to perform calls to the study IVR system to report questionnaire results;
    21. Any other sound medical reason as determined by the clinical investigator.
    22. Legal incompetence or limited legal competence, detainment in an institution for official or legal reasons.
    E.5 End points
    E.5.1Primary end point(s)
    • The entrainment of the circadian melatonin rhythm as measured by urinary 6-sulfatoxymelatonin (aMT6s)
    • The Clinical Response rate corresponding to individuals who have both:
    1. Entrainment of the aMT6s rhythm, and
    2. A score of ≥ 3 on the Non-24 Clinical Response Scale (N24CRS)

    Entrainment is defined as having a τ value ≤ 24.1 and a 95% CI that includes 24.0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the study
    E.5.2Secondary end point(s)
    Key Secondary Endpoints
    • The proportion of responders with a combined sleep/wake response for nighttime sleep duration and daytime sleep duration defined as:
    1. Increase of 90 minutes or greater in LQ-nTST, and
    2. Decrease of 90 minutes or greater in UQ-dTSD
    • The entrainment of the circadian rhythm as measured by cortisol

    Additional Secondary Endpoints
    • The subtype I response rate (sleep time subtype)
    • The subtype II response rate (daytime sleep subtype)
    • The subtype III response rate (MoST subtype)
    • The subtype IV response rate (CGI-C subtype)
    • Treatment response association with aMT6s excretion rate
    • The average of LQ-nTST
    • The average of UQ-dTSD
    • The average of MoST
    • The Clinical Global Impression-Change (CGI-C
    • The entrainment of circadian analytes

    Nighttime sleep is defined as the amount of time slept between the daily dosing time and the scheduled wake time (a 10 hour interval). This will be evaluated through the PSQ.

    Daytime sleep is defined as any sleep episode, lasting more than 5 minutes, occurring during the 14-hours between the subject’s scheduled wake time and their daily dosing time. This will be evaluated through the Pre-SQ.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the study
    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 No
    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 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 Yes
    E.8.1.7.1Other trial design description
    with a single-blind phase and open label extension
    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 No
    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
    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
    Provided in the protocol
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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.1.1Number of subjects for this age range: 0
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    blind patients
    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 15
    F.4.2.2In the whole clinical trial 84
    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)
    No treatment different from the expected normal treatment planned.
    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 Decision2011-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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