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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-005035-41
    Sponsor's Protocol Code Number:THN102-201
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-11
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-005035-41
    A.3Full title of the trial
    SAFETY AND EFFICACY OF THN102 ON SLEEPINESS IN NARCOLEPTIC PATIENTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SAFETY AND EFFICACY OF THN102 ON SLEEPINESS IN NARCOLEPTIC PATIENTS
    A.4.1Sponsor's protocol code numberTHN102-201
    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 SponsorTheranexus SA
    B.1.3.4CountryFrance
    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 supportTheranexus SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheranexus SA
    B.5.2Functional name of contact pointWerner Rein
    B.5.3 Address:
    B.5.3.1Street Address86 rue de Paris
    B.5.3.2Town/ cityOrsay
    B.5.3.3Post code91400
    B.5.3.4CountryFrance
    B.5.4Telephone number+33680 02 67 79
    B.5.6E-mailwerner.rein@theranexus.fr
    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 nameFlecainide acetate
    D.3.2Product code THN02
    D.3.4Pharmaceutical form Capsule
    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 INNFlecainidum
    D.3.9.1CAS number 54143-56-5
    D.3.9.2Current sponsor codeTHN02
    D.3.9.3Other descriptive nameFLECAINIDE ACETATE
    D.3.9.4EV Substance CodeSUB13894MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 2
    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 nameFlecainide acetate
    D.3.2Product code THN02
    D.3.4Pharmaceutical form Capsule
    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 INNFlecainidum
    D.3.9.1CAS number 54143-56-5
    D.3.9.2Current sponsor codeTHN02
    D.3.9.3Other descriptive nameFLECAINIDE ACETATE
    D.3.9.4EV Substance CodeSUB13894MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Modafinil
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameModafinil 100 mg
    D.3.4Pharmaceutical form 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 INNMODAFINIL
    D.3.9.1CAS number 68693-11-8
    D.3.9.4EV Substance CodeSUB09026MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    This Proof-of-Concept, Phase IIa trial with THN102 should collect a sufficient body of information to assess efficacy and safety profile of THN102 versus modafinil alone in patient with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2 (without cataplexy).
    E.1.1.1Medical condition in easily understood language
    narcolepsy
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10028713
    E.1.2Term Narcolepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028715
    E.1.2Term Narcolepsy with cataplexy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007738
    E.1.2Term Cataplexy and narcolepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the superiority of THN102 (combination modafinil and flecainide acetate) vs modafinil for improving the residual daytime sleepiness assessed by Epworth Sleepiness Scale (ESS) in patients with narcolepsy treated by modafinil
    E.2.2Secondary objectives of the trial
    • To quantify the added value of THN102 (modafinil/flecainide acetate combination) for both daily doses (300/27 mg and 300/9 mg) vs modafinil (300/0 mg) for improving cataplexy, sleep paralysis, fatigue, hallucinations, and quality of life
    • To determine the dose response profile of THN102 vs. modafinil on efficacy parameters
    • To assess the safety profile of THN102 doses vs. modafinil
    • To determine the plasma levels of modafinil and flecainide at steady state
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2 (without cataplexy) according to the International Classification of Sleep Disorders (ICSD-3) criteria (see Appendix A for criteria).
    2.The patient is willing and able to fulfill study restrictions and to attend regularly scheduled clinic visits as specified in this protocol, and has signed the informed consent prior to study start.
    3.Males or females, aged between 18 and 65 year-old.
    4.Body mass index >18 kg/m2 and <35 kg/m2.
    5.Patients treated with modafinil at stable dosage for at least 2 months and still complaining of excessive daily somnolence (EDS) despite the treatment
    6.Epworth Sleepiness Scale (ESS) score should be ≥ 14/24 during the baseline period.
    7.Patients with cataplexy are permitted to remain on their anticataplectic medications at stable doses (mainly sodium oxybate or venlafaxine). The authorized anticataplectic treatment should have been administered for at least 2 months prior to entry in the trial and the doses should not be changed throughout the trial.
    8.Patients should have a transthoracic Doppler echocardiography considered as normal (left ventricular ejection fraction >55%, no significant morphological and/or no physiological anomaly, even if not symptomatic).
    9.Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception, and must continue one method for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD).
    10.Informed consent must be obtained for all subjects before enrollment in the study (including specific request for HIV serology and hepatitis as well as for urine screen for drug).
    E.4Principal exclusion criteria
    1.Patients with an untreated sleep apnea syndrome (respiratory disorder index > 30/h) or who have any other cause of daytime sleepiness as assessed on patient history.
    2.Patients working in an occupation requiring variable shift work or routine night shifts.
    3.Patients with suicidal ideations or that has tried to commit suicide in the past 6 months.
    4.Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as Parkinson’s disease, Alzheimer’s disease, Huntington’s Chorea, multiple sclerosis, moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical anxiety or depression, BDI ≥ 21 or with suicidal risk (if item > 0), or other problem that in the investigator’s opinion would preclude the patient’s participation and completion of this trial or comprise reliable representation of subjective symptoms.
    5.Patients currently under one of the following medications (CNS indication):
    a. Neuroleptic, anxiolytic, anticonvulsant, antiemetic (excepted domperidone), opioid, benzodiazepine (zolpidem/ zopiclone however authorized), psychostimulants (except modafinil).
    b. Antidepressants (selective serotonin reuptake inhibitor or modulators, tri- and tetracyclic antidepressants, monoamine oxydase inhibitors) may be given to patients with mild or moderate unipolar depression providing the treatment is maintained at stable dose for at least 6 weeks, is anticipated to remain stable during the study, is well tolerated and devoid of orthostatic hypotension and QTc prolongation as documented at Visit 2 (baseline).
    6.Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
    7.Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation.
    8.Contraindication to flecainide (2nd or 3rd grade atrioventricular block, bifascicular block, complete left bundle branch block, sick sinus syndrome and associated pathologies (such as alternating bradycardia-tachycardia), ventricular arrhythmias if considered as risk, cardiac insufficiency, documented Brugada syndrome, cardiogenic shock, recent or previous myocardial infarction).
    9. Patients currently treated or planned to be treated with anti-arrhythmic drugs class I or with compounds eliciting bradycardia
    10.Concomitant therapy which could elicit drug-drug interactions with flecainide as per SmPC, thus increasing or decreasing plasma concentrations
    11.Patients with a known history of long QTc syndrome (e.g. syncope or arrhythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTcf interval higher than 450 ms (electrocardiogram Fredericia’s corrected QT interval).
    12.Patients with Severe Hepatic or Renal Impairment, or with any other significant abnormality in the physical examination or clinical laboratory results.
    13.Known hypersensitivity to the tested treatment including active substances and excipients for modafinil SmPC and excipients for flecainide capsules (Section 5.1.1)
    14.Women of childbearing potential who intend to be pregnant during the next few months.
    15.Patients without any medical care insurance, or protected by the law (curatelle/tutelle).
    16.Patients participating in any other clinical trial within 60 days prior to entry in this study or still in the protected period imposed by a previous study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean Epworth Sleepiness Scale (ESS) total score at the end of each treatment period
    E.5.1.1Timepoint(s) of evaluation of this end point
    ESS done at each visit: pre-study, V 1 to V6
    E.5.2Secondary end point(s)
    Efficacy
    •Good response on ESS scale: decrease from baseline ΔESS ≥3
    •Absence of residual somnolence: ESS <11
    •Daily sleepiness assessment (modified ESS for EDS daily pattern)
    •14-item fatigue scale
    •European Scale of Quality of Life (EQ-5D)
    •PGI-S (Patient Global Impression for Severity)
    •PGI-C (Patient Global Impression for Change vs. baseline)
    •CGI-S (Clinical Global Impression for Severity) for sleepiness and cataplexy
    •CGI-C for change vs. baseline for sleepiness and cataplexy
    • Information reported on patient diary – completed at home before each visit: Number of diurnal involuntary episodes of sleepiness, Number of diurnal involuntary sleep attacks, Number and duration of voluntary naps and total duration during day time, Number of cataplexy episodes: partial vs generalised, Occurrence of hypnagogic hallucinations and sleep paralysis, Nocturnal awakening, Total duration of nocturnal sleep time.

    Safety and Tolerability
    •Adverse events
    •Vital signs
    •ECG
    •Physical examination
    •Biological safety: With emphasis on renal and hepatic markers, urinalysis; Pregnancy test in urine for women of child-bearing potential)
    •Beck Depression Inventory (BDI) evaluation for depressive symptoms

    Plasma concentrations for modafinil and flecainide at steady state
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy
    6 times, V1 to V6

    Safety and Tolerability
    •Adverse events: spontaneous reporting from signing informed consent to study completion
    •Vital signs at each visit: 6 times, V1 to V6)
    •ECG: 6 times, V1 to V6
    •Physical examination: 2 complete at V1 and V6, 4 abbreviated at V 2, V3, V4, and V5
    •Biological safety: performed 6 times, 3 complete at V0 or V1, V2 and V6, 3 abbreviated for biochemistry for V3, V4, and V5
    •BDI, 6 times, V1 to V6

    Plasma concentrations for modafinil and flecainide at steady state:
    •Time points: 5 plasma samples at V1 to V5
    •Additional PK sample(s) if any additional visit for any reason between Day 16 and 60
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    IIa, Proof of concept
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Modafinil
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years
    E.8.9.1In the Member State concerned months7
    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 months2
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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 Decision2018-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-17
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