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    Summary
    EudraCT Number:2011-004520-35
    Sponsor's Protocol Code Number:VP-VEC-162-3204
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-08-27
    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 number2011-004520-35
    A.3Full title of the trial
    AN EXTENSION OPEN-LABEL SAFETY STUDY OF A 24-MONTH 20MG DOSE REGIMEN OF TASIMELTEON FOR THE TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER (N24HSWD) IN BLIND INDIVIDUALS WITH NO LIGHT PERCEPTION WHO HAVE ENROLLED IN OTHER TASIMELTEON CLINICAL TRIALS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN EXTENSION OPEN-LABEL SAFETY STUDY OF A 24-MONTH 20MG DOSE REGIMEN OF TASIMELTEON FOR THE TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER (N24HSWD) IN BLIND INDIVIDUALS WITH NO LIGHT PERCEPTION WHO HAVE ENROLLED IN OTHER TASIMELTEON CLINICAL TRIALS
    Weiterführende, offene Verträglichkeitsstudie einer 24-monatigen Gabe von 20mg Tasimelteon zur Behandlung von Schlaf-Wach-Störungen mit Abweichung vom 24-Stunden-Rhythmus (N24HSWD) bei blinden Patienten ohne Lichtwahrnehmung, die an einer vorangegangenen klinischen Studie mit Tasimelteon teilgenommen haben
    A.4.1Sponsor's protocol code numberVP-VEC-162-3204
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01429116
    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 number0012027343400
    B.5.5Fax number0012022961450
    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(1R, 2R)-N-[2-(2,3-dihydrobenzofuran-4-yl)-cyclopropylmethyl]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
    Blinde Männer oder Frauen ohne Licht-Wahrnehmung und mit Störung des Schlaf-Wach-Rhythmus mit einer Abweichung vom 24-Stunden-Rhythmus des Tages (N24HSWD)
    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
    Blinde Männer oder Frauen ohne Licht-Wahrnehmung und mit Störung des Schlaf-Wach-Rhythmus mit einer Abweichung vom 24-Stunden-Rhythmus des Tages (N24HSWD)
    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 16.1
    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
    The primary objective of this study is to characterize the effect of tasimelteon, 20 mg/night for 24 months, on standard measures of subject safety.
    E.2.2Secondary objectives of the trial
    not appliacble
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability and acceptance to provide informed consent;
    2. Men or women at least 18 years of age or older who meet one of the following:
    a. Has enrolled in VP-VEC-162-3201 (with sponsor approval)
    b. Has completed VP-VEC-162-3203 (for US participants only)
    c. Did not have a qualifying tau for randomization in VP-VEC-162-3203 (for US participants only)
    d. Has enrolled in VP-VEC-162-3203 (with sponsor approval - for US participants only)
    3. 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 pregnancy test 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)
    4. Diagnosis of N24HSWD in a previous tasimelteon study;
    5. Willing and able to comply with study requirements and restrictions
    E.4Principal exclusion criteria
    1. 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;
    2. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
    3. 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 (> 40g/day);
    4. Patients having any current suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline;
    5. Patient 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;
    6. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
    7. Clinically significant deviation from normal in vital signs measurements, or physical examination findings at screening or baseline as determined by the clinical investigator;
    8. Pregnant or lactating females;
    9. Smoke more than 10 cigarettes/day;
    10. Exposure to any investigational drug other than tasimelteon, including placebo, within 30 days, 5 half-lives, or the exclusion period given by a previous study in which the patient has participated in, whichever of the three scenarios is longer.
    11. Unwilling or unable to discontinue usage of medication listed in Section 8.2.1;
    12. Any other sound medical reason as determined by the clinical investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events (AEs) including suicidal ideation or behavior, changes in vital signs, clinical laboratory evaluations, electrocardiograms (ECGs) and physical exam findings during treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 133
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    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 200
    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 Decision2012-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-01-30
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