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    Summary
    EudraCT Number:2017-004475-31
    Sponsor's Protocol Code Number:THN102-202
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2017-004475-31
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled, complete 3-way
    cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease
    Randomizované, dvojitě-zaslepené, placebem kontrolované, třikrát úplně zkřížené klinické hodnocení fáze IIa posuzující bezpečnost a účinnost dvou dávek THN102 u pacientů s nadměrnou denní spavostí při Parkinsonově nemoci
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.
    Klinické hodnocení posuzující bezpečnost a účinnost dvou dávek THN102 u pacientů s nadměrnou denní spavostí při Parkinsonově nemoci
    A.4.1Sponsor's protocol code numberTHN102-202
    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 S.A.
    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 S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheranexus S.A.
    B.5.2Functional name of contact pointDamien Bouvier
    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 number0033146548379
    B.5.6E-maildamien.bouvier@theranexus.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 nameFlecainide acetate
    D.3.2Product code THN02
    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 INNFlecainidum
    D.3.9.1CAS number 54143-56-5
    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, 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 INNFlecainidum
    D.3.9.1CAS number 54143-56-5
    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 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 Modiodal
    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 nameover-encapsulated Modafinil
    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 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, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Excessive daytime sleepiness associated with Parkinson’s disease
    E.1.1.1Medical condition in easily understood language
    Patients with Parkinson disease (PD) suffering and complaining of daytime sleepiness
    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 SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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 PT
    E.1.2Classification code 10041349
    E.1.2Term Somnolence
    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 safety profile of THN102 (modafinil/flecainide combination) at two doses (200 mg/18 mg and 200 mg/2 mg) versus placebo in subjects with excessive daytime sleepiness associated with Parkinson’s disease (PD).
    E.2.2Secondary objectives of the trial
    1. To quantify the efficacy of THN102 versus placebo in improving sleepiness.
    2. To quantify the efficacy of THN102 versus placebo in improving
    a. attention, vigilance
    b. cognition
    3. To determine the dose response profile of THN102 versus placebo on efficacy parameters.
    4. To determine the plasma levels of modafinil and flecainide at steady state.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Subjects with a diagnosis of idiopathic Parkinson’s disease as defined by the Movement Disorders Society (MDS).
    2. Subjects with Hoehn and Yahr scale score ≤ 4.
    3. Males or females, aged between 18 and 80 years.
    4. Body mass index > 18 kg/m2 and < 35 kg/m2.
    5. Subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching TV, while eating or talking with other people).
    6. Epworth Sleepiness Scale (ESS) score ≥ 14.
    7. Women of childbearing potential (not surgically sterile or < 2 years postmenopausal), must use a highly effective method of contraception, and must continue for the duration of the trial (and for 2 months after participation in the trial). Highly effective methods of contraception include hormonal contraception associated with inhibition of ovulation (combined estrogen/progestogen: oral, intravaginal, transdermal; progestogen-only: oral, implanted, and injected) in conjunction with a barrier method (preferably male condom)., Highly effective methods further include intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner (provided that the partner is the sole sexual partner of the subject and the vasectomised partner has received medical assessment of the surgical success) and sexual abstinence, i.e. when this is in line with the preferred and usual lifestyle of the subject.
    8. Subjects willing and able to follow trial procedures (including to swallow IMP capsules) and to regularly attend scheduled clinic visits as specified in the protocol, and who have signed the informed consent prior to any screening procedure.
    All above-mentioned inclusion criteria will be checked at VS1.
    At VR the following inclusion criteria will be re-checked: 5, 6, 7, 8.
    E.4Principal exclusion criteria
    Exclusion criteria
    1. Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder.
    2. Psychiatric and neurological disorders (other than Parkinson’s disease), such as idiopathic narcolepsy, Alzheimer’s disease, Huntington’s Chorea, multiple sclerosis, epilepsy, psychosis, bipolar disorder, severe clinical anxiety or depression, multiple system atrophy (Shy-Drager syndrome) or other problem that in the investigator’s opinion would preclude the subject’s participation and completion of this trial or comprise reliable representation of subjective symptoms.
    3. Cardiovascular disorders such
    a. Uncontrolled moderate to severe hypertension
    b. ECG QTcF duration ≥ 450 ms (men) or ≥ 470 (women)
    c. ECG signs of left ventricular hypertrophy (exclusion if at least one of the three indices is abnormal):
    • Sokolow-Lyon voltage (sum of amplitude of the S wave in lead V1 and the R wave in lead V5 or V6 ≥ 3.5 mV), or
    • Cornell voltage (S wave in V3 + R wave in aVL > 2.8 mV in men or > 2.0 mV in women), or
    • Modified Cornell (R wave in aVL > 1.1 mV)
    d. Recent (less than three months before screening visit VS1) myocardial infarction
    e. Stable or unstable angina pectoris
    f. Cardiac insufficiency
    g. Previous history of heart failure
    h. Previous history of cardiac valvular surgery
    i. Ventricular arrhythmias considered as clinically significant
    j. Atrial fibrillation unless it is stable and controlled by stable doses of amiodarone, calcium channel blocker or beta-blocker
    k. 2nd or 3rd grade atrioventricular block or chronic bifascicular block, unless an adequate pacemaker is present
    l. Sinus node dysfunction
    m. Documented Brugada syndrome
    4. Subjects with current impulse control disorder.
    5. Subjects showing dementia or with MoCA < 23.
    6. Subjects with current suicidal risk, based on investigator’s clinical judgement or with a “yes” answer to item 4 and/or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at VS1, referring to the last month before screening.
    7. Current or recent (within one year) history of substance abuse or dependence disorder as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V), e. g. alcohol. Tobacco use is accepted.
    8. Other active clinically significant illness, including unstable cardiovascular, or malignant patholog, significant abnormality in physical examination or clinical laboratory results at VS1, which could interfere with the trial conduct or counter-indicate the trial treatments or place the subject at risk during the trial or compromise the trial participation.
    9. Subjects with hepatic impairment (serum total bilirubin ≥ 34 mg/dL, except in patients diagnosed with Gilbert’s syndrome, or prothrombin time [PT] ≥ 4 s (except in patients on therapeutic anti-coagulation), or serum albumin < 3.5 g/dL)), or renal impairment (glomerular filtration rate [GFR] < 60 mL/min/1.73 m2, according to Kidney Disease Improving Global Outcomes (KDIGO)).
    10. Known hypersensitivity to IMP (active ingredients or excipients of modafinil or flecainide capsules).
    11. Subjects currently (or within 6 weeks before VS1) under one of the following medications (isolated intake up to 1 week can be accepted):
    a. Neuroleptics, anxiolytics, anticonvulsants. Benzodiazepines and benzodiazepine-like drugs are only authorised if used regularly at stable indicated doses with an evening intake as sleep promoting agents.
    b. Flecainide or other class I antiarrhythmic drugs.
    c. Psychostimulants (except caffeine if no abuse and stable consumption) such as, but not limited to, modafinil, methylphenidate, amphetamine.
    d. Antidepressants except if maintained at stable dose for at least 6 weeks before visit VS1 and anticipated to remain stable during the trial in subjects with mild or moderate unipolar depression.
    e. Antiemetic medications (except domperidone), myo-relaxing drugs and opioids.
    f. Dopaminergic medications, unless they have been used at stable doses for at least 4 weeks before screening and it is anticipated that the doses will not be changed throughout the trial. Efficacious medication for Parkinson's disease should not be discontinued for the sole purpose of the subject's enrolment into this clinical trial but must be maintained at stable dosage levels.
    g. Centrally acting anti-obesity drugs.
    h. TNF-alpha inhibitors.
    12. Pregnancy or lactation. Women of childbearing potential who intend to be pregnant during the next few months.
    13. Subjects protected by the law (legal guardianship).
    14. Subjects participating in any other clinical trial within 60 days prior to visit VS1 in this trial or still in the protected period imposed by a previous trial.
    15. Subjects working in an occupation requiring variable shift work or routine night shifts.
    16. Subjects who plan to travel involving time zone changes.
    All above-mentioned exclusion criteria will be checked at VS1.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints
    1. Adverse events
    2. Safety laboratory
    3. Vital signs change
    4. Electrocardiogram assessments
    5. Columbia-Suicide Severity Rating Scale (C-SSRS)
    6. MDS-UPDRS
    7. QUIP-RS


    Efficacy endpoints
    Key efficacy endpoint
    8. Mean ESS score change from baseline at the end of each treatment period
    Secondary efficacy endpoints
    9. ESS score responder rate, defined as the proportion of subjects with at least 25% ESS improvement from baseline, at the end of each treatment period
    10. Absence of residual somnolence, i.e. ESS < 11 at the end of each treatment period
    11. Psychomotor Vigilance Test (PVT) variables change from baseline at the end of each treatment period
    12. MoCA score change from baseline at the end of each treatment period
    13. Actimetry change (inactivity) from baseline at the end of each treatment period
    14. Number and duration of diurnal involuntary sleep attacks (subject diaries) change from baseline at the end of each treatment period
    15. Episodes of somnolence (subject diaries) change from baseline at the end of each treatment period
    E.5.1.1Timepoint(s) of evaluation of this end point
    After trial termination.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Czech Republic
    France
    Germany
    Hungary
    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
    Last subject last visit.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 60
    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)
    After the end of the trial, the subjects will be treated according to local standard practice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-18
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