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    Summary
    EudraCT Number:2018-003742-17
    Sponsor's Protocol Code Number:TV50717-CNS-30080
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-01
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-003742-17
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test if TEV-50717 is Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
    A.3.2Name or abbreviated title of the trial where available
    RECLAIM-DCP
    A.4.1Sponsor's protocol code numberTV50717-CNS-30080
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03813238
    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 SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Branded Pharmaceutical Products R&D Inc.
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street Address41 Moores Road
    B.5.3.2Town/ cityFrazer, Pennsylvania
    B.5.3.3Post code19355
    B.5.3.4CountryUnited States
    B.5.4Telephone number00197298361100
    B.5.6E-maildavid.shalhevet@teva.co.il
    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 Austedo
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Branded Pharmaceuticals Products R&D Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameTEV-50717 (deutetrabenazine)
    D.3.2Product code TEV-50717
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNdeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeTEV-50717
    D.3.9.3Other descriptive nameDEUTETRABENAZINE
    D.3.9.4EV Substance CodeSUB179485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeTEV-50717
    D.3.9.3Other descriptive nameDEUTETRABENAZINE
    D.3.9.4EV Substance CodeSUB179485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeTEV-50717
    D.3.9.3Other descriptive nameDEUTETRABENAZINE
    D.3.9.4EV Substance CodeSUB179485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeTEV-50717
    D.3.9.3Other descriptive nameDEUTETRABENAZINE
    D.3.9.4EV Substance CodeSUB179485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeTEV-50717
    D.3.9.3Other descriptive nameDEUTETRABENAZINE
    D.3.9.4EV Substance CodeSUB179485
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 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
    Dyskinesia in cerebral palsy (DCP)
    E.1.1.1Medical condition in easily understood language
    Dyskinesia in cerebral palsy (DCP)
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068804
    E.1.2Term Athetoid cerebral palsy
    E.1.2System Organ Class 100000004850
    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 the study is to evaluate the efficacy of TEV-50717 to reduce the severity of dyskinetic involuntary movements associated with CP.
    E.2.2Secondary objectives of the trial
    A secondary objective is to evaluate the specific efficacy parameters of TEV-50717 beyond the measure of the primary objective.
    A secondary objective of the study is to evaluate the safety and tolerability of TEV-50717.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is 6 through 18 years of age (inclusive) at baseline.
    2.Patient weighs at least 26 pounds (12 kg) at baseline.
    3.Patient has had CP symptoms since infancy (≤2 years), and CP is judged by the investigator to be of a nonprogressive nature.
    4.Patient has a diagnosis of DCP according to the Surveillance of Cerebral Palsy in Europe criteria.
    5.Patient has an MD-CRS part II total score of ≥ 10 at the baseline visit, based on investigator scoring of chorea.
    6.Patient’s symptoms are causing functional problems determined by a CGI-S score of 4 or greater based on investigator scoring.
    7.Choreiform is the predominant (ie, the main cause of impairment or distress) movement disorder as assessed at screening.
    8.Patient is able to swallow study medication whole.
    9.Patient and caregiver are willing to adhere to the medication regimen and to comply with all study procedures.
    10.Patient is in good general health, as indicated by medical and psychiatric history, as well as physical and neurological examination.
    11.In the investigator’s opinion, the patient and caregiver have the ability to understand the nature of the study and its procedures, and the patient is expected to complete the study as designed.
    12. For a patient who is a minor, the parent(s)/legally accepted representative provide written informed consent, and the patient provides assent (in accordance with local regulations) and the legally acceptable representative will sign, if needed. In this study, eligible patients are patients with dyskinetic CP who may have some degree of mental, motor, and/or communication (eg, speech, writing, etc) limitations or disabilities. The patient may not be able to read the assent/consent form. Some patients may only be able to provide a limited assent/consent (for instance, by verbalizations
    or gestures). The investigator will determine the suitability of enrolling such patients in this study and will follow the local regulation to obtain
    the relevant assent/consent.
    13.Caregivers provide written informed consent after being assigned the role by an adult patient, or if this role is delegated by the parent/legally
    accepted representative of a patient who is a minor.
    14.Females who are postmenarchal or ≥12 years of age may be included only if they have a negative beta human chorionic gonadotropin (β HCG) test at baseline or are sterile. Definitions of sterile, premenarchal, and postmenarchal are given in Appendix F.
    15.Females who are postmenarchal or ≥12 years of age whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study (ie, starting at screening) and for 30 days after the last dose of IMP. Further details are included in Appendix F of the protocol.
    E.4Principal exclusion criteria
    1.a. Patient has a predominant movement disorder other than dyskinesia.
    b. Patient’s predominant motor symptoms are dystonic.
    c. Patient’s predominant motor symptoms are spastic.
    d. Patient has another other movement disorder that could impair the motor assessment in the MD-CRS part II.
    e. Patient has choreiform movement disorder that has not been consistent throughout the life of the patient.
    2.Patient has clinically significant depression at screening or baseline.
    Note: Patients receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening and anticipated to
    remain stable (dose and frequency) within the study duration.
    3.Patient has a history of suicidal intent or related behaviors based on medical or psychiatric history or the C-SSRS within 2 years of screening:
    Previous intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought
    Previous suicidal preparatory acts or behavior
    4.Patient has a history of a previous actual, interrupted, or aborted suicide attempt based on medical or psychiatric history or the C-SSRS.
    5.Patient has a first-degree relative who has completed suicide.
    6.Patient has received any of the following concomitant medications within the specified exclusionary windows of screening:
    Within 30 days: tetrabenazine, deutetrabenazine, or valbenazine
    Within 21 days: reserpine
    Within 14 days: levodopa, dopamine agonists, and MAOIs
    7.Patient has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for
    treatment of abnormal movements or CP within 6 months of the screening visit, or the patient is not in a stable clinical condition.
    8.Patient has recent surgical procedure or is anticipated to have a surgical procedure during the study that, in the opinion of the investigator, makes the patient unsuitable for the study.
    9.Patient has a severe mental disability or an unstable or serious medical illness (eg, epilepsy) at screening or baseline that, in the opinion of the
    investigator, could jeopardize or would compromise the patient's ability to participate in this study.
    10.Patient has a QT interval corrected for heart rate using Fridericia's
    formula (QTcF) value >450 msec on 12-lead ECG at screening.
    11.Patients with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
    12. Patient has evidence of diminished hepatic function, as indicated by the following:
    Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 × the upper limit of the normal range (ULN) at screening
    Alkaline phosphatase (ALP) or total bilirubin >2 × ULN at screening
    Note: Patients with Gilbert’s syndrome are eligible to participate if approved by the medical monitor.
    Note: Patients with abnormalities in 2 or more of the following clinical laboratory parameters must be approved for enrollment by the medical monitor: AST, ALT, ALP, and total bilirubin.
    13. Patient has evidence of clinically significant renal impairment, indicated by a serum creatinine >1.5 × ULN at screening.
    14. Patient has a known allergy to any of the components of the IMP.
    15. Patient has participated in an investigational drug or device study and received IMP/intervention within 30 days or 5 drug half-lives of screening, whichever is longer.
    16. Patient is pregnant or breastfeeding.
    17. Patient has a history of or acknowledges alcohol or other substance abuse in the 12 months before screening.
    18. Patient has a positive urine drug screen test result (with exception of medications listed in Table 10 of Appendix H of protocol). Any request to
    include a patient with a positive urine drug screen test result should be discussed with, and approved by, the medical monitor. Refer to Section
    7.5.2.2 of the protocol (urine drug screen) for more details.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline to week 15 in the MD-CRS part II total score (movement disorder severity, centrally read) (TEV-50717 versus placebo).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 15
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints (TEV-50717 versus placebo) are the following:
    •MD-CRS part I total score (general assessment, centrally read) change from baseline to week 15
    •CaGI-I Scale (global, caregiver rated) at week 15
    •CGI-I Scale (global, physician rated) at week 15
    Other efficacy measures and endpoints (TEV-50717 versus placebo) include the following:
    •MD-CRS Global Index (calculated from MD CRS parts I and II total scores)
    •UHDRS-TMS
    •UHDRS-TMC
    •UHDRS-TMD
    •PEDI-CAT (ADL, caregiver completed, content-balanced version)
    •The CP module of the PedsQL (QoL, patient/caregiver)
    •PGI-I Scale (global, patient/caregiver)
    •CGI-S Scale (global, physician rated)
    •CaGI-I response, defined as patients who are described by the caregiver as “Much Improved” or “Very Much Improved” in the CaGI-I score
    •CGI-I response, defined as patients who are described as “Much Improved” or “Very Much Improved” in the CGI-I score
    •CGI-S response, defined as patients who have a reduction of ≥1 point in the CGI-S score
    •PGI-I response, defined as patients who are described as “Much Improved” or “Somewhat Improved” in the PGI-I score

    The safety variables include adverse events (and the number of patients who withdraw from the study due to adverse events), vital signs, laboratory tests (hematology, chemistry, and urinalysis), ECG measurements, CBCL, ESRS, ESS, and the children’s C-SSRS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    17 weeks
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Belgium
    Canada
    Denmark
    France
    Israel
    Italy
    Poland
    Russian Federation
    Slovakia
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years3
    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 years4
    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 Yes
    F.1.1Number of subjects for this age range: 185
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 85
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 85
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients below the age of 14 require informed consent or co-consent for patients 14 years of age and older, where applicable.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 185
    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)
    Patients who complete the study may be eligible to begin participation in the open label safety extension study. At the week 16 visit, patients may choose to enter the open label safety extension study (on that day) or up to 1 week later (2 weeks from the week 15 visit). Patients who complete treatment, but choose not to participate in the open-label safety extension study before week 17 of the study will be contacted for a safety evaluation call occurring 2 weeks after their last dose of IMP.
    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 Decision2019-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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