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    Summary
    EudraCT Number:2017-002628-26
    Sponsor's Protocol Code Number:ZX008-1601
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-002628-26
    A.3Full title of the trial
    A Two-Part Study of ZX008 in Children and Adults with
    Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized,
    Double-blind, Placebo-controlled Trial of Two Fixed Doses
    of ZX008 (Fenfluramine Hydrochloride) Oral Solution as
    Adjunctive Therapy for Seizures in Children and Adults with
    LGS, Followed by Part 2: An Open-label Extension to
    Assess Long-Term Safety of ZX008 in Children and Adults
    with LGS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Two-Part Study of ZX008 in Children and Adults with
    Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized,
    Double-blind, Placebo-controlled Trial of Two Fixed Doses
    of ZX008 (Fenfluramine Hydrochloride) Oral Solution as
    Adjunctive Therapy for Seizures in Children and Adults with
    LGS, Followed by Part 2: An Open-label Extension to
    Assess Long-Term Safety of ZX008 in Children and Adults
    with LGS
    A.4.1Sponsor's protocol code numberZX008-1601
    A.5.4Other Identifiers
    Name:INDNumber:132604
    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 SponsorZogenix International Limited
    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 supportZogenix International Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINC Research/inVentiv Health
    B.5.2Functional name of contact pointTamie Sather
    B.5.3 Address:
    B.5.3.1Street AddressNone
    B.5.3.2Town/ cityNone
    B.5.3.4CountryUnited States
    B.5.4Telephone number1425281 0843
    B.5.6E-mailtamie.sather@syneoshealth.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/3/17/1836
    D.3 Description of the IMP
    D.3.1Product nameFENFLURAMINE HYDROCHLORIDE
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNFenfluramine
    D.3.9.1CAS number 404-82-0
    D.3.9.2Current sponsor codeZX008
    D.3.9.3Other descriptive nameFenfluramine HCl, DL-Fenfluramine, (±)-Fenfluramine
    D.3.9.4EV Substance CodeSUB02115MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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 placeboOral solution
    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
    Lennox-Gastaut Syndrome in Children and Adults
    E.1.1.1Medical condition in easily understood language
    NA
    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 PT
    E.1.2Classification code 10048816
    E.1.2Term Lennox-Gastaut syndrome
    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
    The primary objective of Part 1 is to evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS) based on the change in frequency of seizures that result in drops between baseline and the combined Titration and Maintenance Periods (T+M)
    The primary objective of Part 2 is to assess the long-term safety and tolerability of ZX008 in children and adults with LGS with regard to adverse events (AEs), laboratory parameters, physical examination, neurological examination, suicidality, cognition (BRIEF), vital signs (blood pressure, heart rate, temperature, and respiratory rate), electrocardiograms (ECG), echocardiograms (ECHO), body weight, and BMI.
    E.2.2Secondary objectives of the trial
    The key secondary objectives of Part 1 are:
    • Evaluation of effect of ZX008 0.2 mg/kg/day vs placebo as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with LGS based on the change in frequency of seizures that result in drops between baseline and T+M
    • Evaluation of effect of ZX008 0.2 and 0.8 mg/kg/day (independently) vs placebo on the endpoints listed in Protocol synopsis.
    The secondary objectives of Part 2 are assessment of effect of ZX008 relative to the baseline on the effectiveness measures, and determination of incidence of medical services used to treat seizures; of status epilepticus and of rescue medication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit. Female subjects of childbearing potential must not be pregnant or breast-feeding. Female subjects of childbearing potential must have a negative urine pregnancy test at screening. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control (see Section 4.4), which includes abstinence, while being treated on this study and for 90 days after the last dose of study drug.
    2.Subject must have a diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments. (Subjects without a formal diagnosis may still be enrolled at sponsor discretion if all other criteria are met.)
    3.Subjects must meet all of the following 4 criteria for Lennox-Gastaut syndrome, as defined in this protocol:
    a. Onset of seizures at 11 years of age or younger.
    b. Multiple seizure types (must include TS or TA), including countable motor seizures that result in drops. Countable motor seizure types eligible for inclusion are: GTC, TS, CS, AS, FS with observable motor symptoms and MS with a drop.
    c. Abnormal cognitive development.
    d. Evidence of EEG in the medical history that shows abnormal background activity accompanied by slow spike and wave pattern <2.5 Hz. (Acceptable evidence includes a copy of the EEG trace, EEG report, or physician note that appropriately describes the EEG findings.)
    4. Subject must have had at least 8 drop seizures in the last 4 weeks prior to inclusion (minimum of 4 drop seizures in the first two weeks and 4 in the last two weeks before baseline), by parent/guardian report to investigator or investigator medical notes
    5. Receiving at least 1 concomitant AED and up to 4 concomitant AEDs, inclusive. KD and VNS are permitted but do not count towards the total number of AEDs. Rescue medications for seizures are not counted towards the total number of AEDs.
    6. All medications or interventions for epilepsy (including KD and VNS) must be stable for at least 4 weeks prior to screening and are expected to remain stable throughout the study.
    7. Subject has been informed of the nature of the study and informed consent has been obtained from the legally responsible parent/guardian.
    8. Subject has provided assent in accordance with Institutional Review Board (IRB)/Ethics Committee requirements, if capable.
    9. Subject’s parent/caregiver is willing and able to be compliant with diary completion, visit schedule and study drug accountability.

    Randomization Inclusion Criteria: Subjects must meet all of the inclusion criteria and none of the exclusion criteria above and meet the following criteria in order to be randomized:
    1. Subject has been approved for study inclusion by the Epilepsy Study Consortium.
    2. Subject does not have an exclusionary cardiovascular or cardiopulmonary abnormality based on ECHO, ECG or physical examination and is approved for entry by the central cardiac reader. Exclusionary abnormalities include, but are not limited to:
    a. Trace or greater mitral or aortic valve regurgitation in subjects ≤18 years of age
    b. Mild or greater mitral or aortic valve regurgitation in subjects >18 yrs of age
    c. Possible signs of pulmonary hypertension with abnormal or greater than upper range of normal values
    d. Evidence of left ventricular dysfunction (systolic or diastolic)
    3. Subject demonstrates a stable baseline with ≥ 2 seizures per week resulting in drops during the 4-week Baseline Period.
    4. Subject’s parent/caregiver has been compliant with diary completion during the Baseline Period, in the opinion of the investigator and sponsor.

    Selection Criteria for Part 2
    To be included in Part 2 all subjects must continue to meet the Selection Criteria for Part 1 (except for criteria related to seizure frequency). If a subject entering Part 2 does not meet Randomization Criteria 2 regarding cardiovascular abnormalities, Section 8.9.1 Follow-up of Cardiovascular Findings will be applied to determine eligibility to continue into Part 2.
    1. All subjects must have satisfactorily completed Part 1 of the study in the opinion of the investigator and the sponsor.
    2. Those subjects who do not complete the 12-week Maintenance Period of Part 1 may, on a case-by-case basis, be eligible for entrance after consideration of the circumstances of the early termination and the potential benefit-risk of continued participation in a ZX008 trial. The decision whether to permit participation in Part 2 for subjects who do not complete Part 1 resides solely with the sponsor, who may consult with the site investigator, the ICAB and/or the IDSMC.
    E.4Principal exclusion criteria
    1. Subject has a known hypersensitivity to fenfluramine or any of the excipients in the study medication.
    2. Subject’s etiology of seizures is a degenerative neurological disease.
    3. Subject has a history of hemiclonic seizures in the first year of life.
    4. Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably.
    5. Subject has pulmonary arterial hypertension.
    6. Subject has current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke, or clinically significant structural cardiac abnormality, including but not limited to mitral valve prolapse, atrial or ventricular septal defects, patent ductus arteriosis (note: Patent Foramen Ovale or a bicuspid valve are not considered exclusionary).
    7. Subject has current or recent history of Anorexia Nervosa, bulimia, or depression within the prior year that required medical treatment or psychological treatment for a duration greater than 1 month.
    8. Subject has a current or past history of glaucoma.
    9. Subject has had an anoxic episode requiring resuscitation within 6 months of the Screening Visit.
    10. Subject has moderate or severe hepatic impairment. Asymptomatic subjects with mild hepatic impairment (elevated liver enzymes < 3x ULN and/or elevated bilirubin <2x ULN) may be entered into the study after review and approval by the Medical Monitor in conjunction with the sponsor, in consideration of comorbidities and concomitant medications.
    11. Subject has severe renal impairment (estimated glomerlular filtration rate <30mL/min/1.73m2)
    12. Subject is receiving concomitant therapy with any of the following: centrally-acting anorectic agents; monoamine-oxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; other centrally-acting noradrenergic agonists, including atomexetine; or cyproheptadine (see Appendix 1 for a complete list of prohibited medications). (Note: Short-term medication requirements for prohibted medications will be handled on a per case basis by the Medical Monitor.)
    13. Subject has positive result on urine tetrahydrocannabinol (THC) Panel or whole blood cannabidiol (CBD) at the Screening Visit.
    14. Subject is taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit.
    15. Subject is known to be human immunodeficiency virus (HIV) positive.
    16. Subject is known to have active viral hepatitis (B or C)
    17. Subject is currently receiving an investigational product.
    18. Subject has participated in another clinical trial within the past 30 days (calculated from that study’s last scheduled visit). Participation in non-treatment trials will be reviewed by the medical monitor.
    19. Subject is at imminent risk of self-harm or harm to others, in the investigator’s opinion, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects must be excluded if they report suicidal behavior in the past 6 months as measured by the C-SSRS at Screening or Baseline, which includes suicidal ideation with intent and plan (Item #5). If a subject reports suicidal ideation on Item 4 without specific plan, and the investigator feels that the subject is appropriate for the study considering the potential risks, the investigator must document appropriateness for inclusion, and discuss with the parent/caregiver to be alert to mood or behavioral changes, especially around times of dose adjustment.
    20. Subject is unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
    21. Subject is institutionalized in a general nursing home (ie, in a facility that does not provide skilled epilepsy care).
    22. Subject does not have a reliable caregiver who can provide seizure diary information throughout the study.
    23. Subject has a clinically significant condition, including chronic obstructive pulmonary disease, interstitial lung disease, or portal hypertension, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    Efficacy:
    The efficacy endpoint for Part 1 of the study is:
    • Number, frequency, and duration of countable seizures that result in drops for the 0,8 mg/kg/day

    E.5.1.1Timepoint(s) of evaluation of this end point
    Data from Part 1 will constitute the primary analyses of the study and will be performed upon database lock after the last subject enrolled has completed the last study visit of Part 1.
    The frequency of seizures that result in drops during the Part 2 OLE Treatment Period will be compared to baseline frequency measured prior to randomization in Part 1. Both the mean and median change from baseline will be presented and the statistical significance of the change will be assessed using a Wilcoxon signed-rank test. Other secondary assessments will be compared to baseline from prior to Part 1, or by visit throughout Part 1 and Part 2, as appropriate.
    E.5.2Secondary end point(s)
    Number, frequency, and duration of countable seizures that do not result in drops
    • Number, frequency, and duration of all countable seizures by type
    • Proportion of subjects who achieve a ≥25%, ≥50%, ≥75%, or 100% reduction from baseline in seizure frequency
    • Number of seizure-free days
    • Clinical Global Impression – Improvement as assessed by parent/caregiver
    • Clinical Global Impression – Improvement as assessed by principal investigator
    • Affective symptoms of parent/caregiver using the HADS scale
    • Number of episodes of status epilepticus
    • Number of instances of rescue medication use and number of doses
    • Incidence in use of medical services to treat seizures

    Efficacy endpoints for Part 2 are identical, with the exception of the HADS and CGI assessments, which are exploratory during the open-label extension.

    Safety:
    The safety endpoints for Part1 and Part 2 of the study are:
    • AEs
    • Laboratory safety (hematology, chemistry, urinalysis)
    • Vital signs (blood pressure, heart rate, temperature, and respiratory rate)
    • Physical examination
    • Neurological examination
    • BRIEF to measure changes in cognition of the subject
    • Columbia Suicidality Severity Rating Scale (C-SSRS)
    • 12-lead ECGs
    • Doppler ECHOs
    • Body weight and BMI

    Exploratory:
    The exploratory endpoints for Part 1 and Part 2 of the study are:
    • VABS
    • QOLCE
    • Zarit Caregiver Burden Inventory

    Pharmacokinetics:
    Steady-state plasma fenfluramine and norfenfluramine PK parameters (average plasma concentration (Cavg ss) and area under the concentration time curve from time zero to time=t (AUC0-t) after administration of ZX008 derived using a PBPK model.


    Part 2
    The primary objective of Part 2 is to assess the long-term safety and tolerability of ZX008 in children and adults with LGS with regard to AEs, laboratory parameters, physical examination, neurological examination, vital signs, ECG, ECHO, and body weight.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Australia
    Austria
    Belgium
    Canada
    Denmark
    Finland
    France
    Germany
    Ireland
    Israel
    Italy
    Japan
    Mexico
    Netherlands
    Norway
    Poland
    Spain
    Sweden
    Switzerland
    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 years
    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 years3
    E.8.9.2In all countries concerned by the trial months11
    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: 150
    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: 75
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 75
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    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
    Parent or Legal Guardian will sign Consent in case Adult patients will be incapable to give a consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 71
    F.4.2.2In the whole clinical trial 225
    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)
    Follow-up cardiovascular safety assessments, including ECG and ECHO, will be performed 3-6 months following the last dose of study medication for all subjects, regardless of whether they complete the entire study or terminate early, unless the subject was known to be taking placebo (ie, blind was broken or subject was in Part 2). If the drug is not approved by the end of open label portion of the study, Sponsor will amend the open label portion of the study to extend the study duration.
    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 Decision2018-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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