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    Summary
    EudraCT Number:2018-001664-38
    Sponsor's Protocol Code Number:FFA-MAE
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-04-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2018-001664-38
    A.3Full title of the trial
    A proof of concept and assessment of maximal effect study with low dose Fenfluramine as add-on therapy in Myoclonic Astatic Epilepsy (Doose-Syndrome)
    Konzeptnachweis und Bewertung der Maximalwirkung mit niedrig dosiertem Fenfluramin als Zusatztherapie bei myoklonisch-astatischer Epilepsie (Doose-Syndrom)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Investigation to see if the investigational product ZX008 (fenfluramine hydrochloride) contributes to reducing the incidence of seizures in children and young adults with Doose syndrome, an early childhood form of epilepsy.
    Eine Studie, in der beobachtet werden soll , ob das Prüfpräparat ZX008 (Fenfluraminhydrochlorid) zur Senkung der Häufigkeit von Krampfanfällen bei Kindern und Jugendlichen mit Doose-Syndrom, einer früh-kindlichen Form der Epilepsie, beiträgt.
    A.3.2Name or abbreviated title of the trial where available
    FFA-MAE
    A.4.1Sponsor's protocol code numberFFA-MAE
    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 SponsorUniversity Hospital Schleswig-Holstein (UKSH)
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUKSH
    B.5.2Functional name of contact pointDepartment of Children and adolesce
    B.5.3 Address:
    B.5.3.1Street AddressArnold-Heller-Str. 3
    B.5.3.2Town/ cityKiel
    B.5.3.3Post code24105
    B.5.3.4CountryGermany
    B.5.4Telephone number0049043150024140
    B.5.5Fax number0049043150024104
    B.5.6E-mailirene.lehmann@uksh.de
    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 nameFenfluramine hydrochloride
    D.3.4Pharmaceutical form Oral solution
    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 INNFENFLURAMINE HYDROCHLORIDE
    D.3.9.1CAS number 404-82-0
    D.3.9.2Current sponsor codeFFA
    D.3.9.4EV Substance CodeSUB02115MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Childhood epilepsy: Myoclonic Astatic Epilepsy (Doose-Syndrome)
    Epilepsie im Kindesalter: Myoklonisch-astatische Epilepsie (Doose-Syndrom)
    E.1.1.1Medical condition in easily understood language
    Doose Syndrome is an epileptic condition in children. The seitures can be frequent and involve the abrupt loss of muscle control, causing the child to fall to the ground, often resulting in injury.
    Das Doose-Syndrom ist eine epileptische Erkrankung bei Kindern. Die Anfälle können häufig sein und zum abrupten Verlust der Muskelkontrolle führen, was oft zu Stürzen und Verletzungen führt.
    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 10015040
    E.1.2Term Epilepsy equivalent
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this proof of concept study is to investigate the efficacy of low dose Fenfluramine as add-on therapy 0.4 or 0.8 mg/kg/day (max 30.0 mg/day).
    Ziel dieser Proof-of-Concept-Studie ist es die Wirksamkeit von niedrig dosiertem Fenfluramin als Zusatztherapie mit 0.4 or 0.8 mg/kg/Tag(max 30.0 mg/Tag) zu untersuchen.
    E.2.2Secondary objectives of the trial
    The aim of this proof of concept study is to investigate the quality of life and safety of low dose Fenfluramine as add-on therapy 0.4 or 0.8 mg/kg/day (max 30.0 mg/day).
    Ziel dieser Proof-of-Concept-Studie ist es die Lebensqualität und Sicherheit bei der Gabe von niedrig dosiertem Fenfluramin als Zusatztherapie mit 0.4 or 0.8 mg/kg/Tag(max 30.0 mg/Tag) zu untersuchen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of Doose syndrome
    • Age: 1 to 17 years.
    • Normal cognitive development before the onset of epilepsy and absence of organic cerebral abnormalities.
    • Onset of myoclonic, myoclonic-(atonic) astatic or atonic-astatic seizures, absences, status of „petit mal“, generalized tonic clonic seizures; sometimes febrile seizures occur before the start of epilepsy.
    • Multiple seizure types (at least 2) including in any case myoclonic atonic seizures
    • at least 6 documented seizures in the last 4 weeks before inclusion
    • on >= 1AED during the 4 weeks before inclusion
    • Presence on EEG of biparietal theta background rhythm, and irregularly generalized spike wave, and polyspike wave
    - Diagnose einer myoklonisch-astatischen Epilepsie (Doose-Syndrom)
    - Alter 1 – 17 Jahre
    - Initial-Entwicklung bis zum ersten Anfall normal, keine zerebrale Abnormalitäten
    - Myoklonisch, myoklonisch-(atonisch) astatisch oder atonisch-astatische Anfälle, Absencen, Status “petit mal”, generalisiert tonisch klonische Anfälle, zum Teil Fieberkrämpfe vor Beginn der Epilepsie
    - Mind. 2 Anfallsarten, eine davon myoklonisch-atonischer Anfall
    - Mind. 6 dokumentierte Anfälle innerhalb der vergangenen 4 Wochen vor Einschluss in die Studie
    - Patient erhält mehr als ein antiepileptisches Medikament während der vergangenen 4 Wochen vor Einschluss in die Studie
    - EEG zeigt biparietalen Theta Grundrhytmus, und irregulare generalisierte spike wave und polyspike wave
    E.4Principal exclusion criteria
    • Any cardiovascular abnormality
    • Abnormal weight (below age specific 3rd percentile)
    • Cortical structural brain lesions.
    • Presence of severe and benign myoclonic epilepsy (SME, BME) in infancy and early childhood
    • Presence of cryptogenic Lennox-Gastaut syndrome, based on the ILAE definitions
    • Presence of atypical benign partial epilepsy/pseudo-Lennox-syndrome
    • Presence of other symptomatic / cryptogenic epilepsies (e.g. with a frontal lobe semiology).
    • Progressive neurodegenerative disease
    • certain drugs
    • Glaucoma
    - Kardiovaskuläre Auffäligkeit
    - abnormales Gewicht (unterhalb des 3. altersspezifischen Percentils)
    - Kortikale strukturelle Läsionen im Gehirn
    - Präsenz von schwerwiegender und gutartiger myoklonischer Epilepsie (SME, BME) im Säuglings- und frühen Kindesalter
    - Kryptogenetisches Lennox-Gastaut-Syndrom (gem. ILAE Definition)
    - Pseudo-Lennox-Gastaut-Syndrom
    - Andere symptomatische oder kryptogenetische Epilepsien
    - Fortschreitende neurodegenerative Erkrankungen
    - bestimmte Medikamente
    - Glaukom
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy of add-on FFA in Myoclonic Astatic Epilepsy
    • Number of responders at each FFA dosage (0.4 or 0.8mg/kg/day) after a four week treatment with 0.4mg/kg/d or 0.8mg/kg/d (week 11/16)
    • Number of seizure free subjects at each FFA dosage (0.4 or 0.8mg/kg/day) after a four-week treatment with 0.4mg/kg/d or 0.8 mg/kg/day (week 11/16)
    • Number of seizure free days per subject during four week treatment with 0.4 mg/kg/d of FFA
    • Number of seizure free days per subject during four week treatment with 0.8mg/kg/d of FFA
    • Seizure frequency change per subject and per major seizure type: generalized tonic-clonic seizures (GTKA), tonic seizures (TS), atonic seizures (AS), absences (typical o atypical, AB), myoclonic seizures (MS) during four week treatment (0.4 mg/kg/d and 0.8 mg/kg/d)
    Wirksamkeit der Zusatz-FFA bei myoklonischer astatischer Epilepsie
    • Anzahl der Responder bei jeder FFA-Dosis (0,4 oder 0,8mg/kg/Tag) nach 4-wöchiger Behandlung mit 0,4mg/kg/Tag oder 0,8mg/kg/Tag (Woche 11/16)
    • Anzahl der anfallsfreien Patienten bei jeder FFA-Dosis (0,4 oder 0,8 mg / kg / Tag) nach 4-wöchiger Behandlung mit 0.4 mg/kg/Tag oder 0.8mg/kg/Tag (Woche 11/16)
    • Anzahl der anfallsfreien Tage pro Patient während der 4-wöchigen Behandlung mit 0.4 mg/kg/Tag
    • Anzahl der anfallsfreien Tage pro Patient während der 4-wöchigen Behandlung mit 0.8 mg/kg/Tag
    • Änderung der Anfallshäufigkeit pro Patient und pro Hauptanfalltyp (tonisch klonische Anfälle (TCS), tonische Anfälle (TS), atonische Anfälle (AS), fokale Anfälle (FS), myoklonische Anfälle (MS) während der 4-wöchigen Behandlung (0.4mg/kg/Tag und 0.8mg/kg/Tag)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy of add-on FFA in Myoclonic Astatic Epilepsy
    • Number of responders at each FFA dosage: after week 11 (0.4mg/kg/d) / after week 16 (0.8mg/kg/d)
    • Number of seizure free subjects at each FFA dosage: after week 11 (0.4mg/kg/d) / after week 16 (0.8mg/kg/d)
    • Number of seizure free days per subject with 0.4mg/kg/d: during four-week treatment (week 7 - 11)
    • Number of seizure free days per subject with 0.8mg/kg/d during four-week treatment (week 12-16)
    • Seizure frequency change per subject and per major seizure type (Tonic Clonic Seizures (TCS), Tonic Seizures (TS), Atonic Seizures (AS), Focal Seizures (FS), myoclonic seizures (MS)): after week 11 (0.4mg/kg/d) / after week 16 (0.8mg/kg/d)
    Wirksamkeit der Zusatz-FFA bei myoklonischer astatischer Epilepsie
    • Anzahl der Responder bei jeder FFA-Dosis: nach Woche 11 (0,4mg/kg/Tag) / nach Woche 16 (0,8mg/kg/Tag)
    • Anzahl der anfallsfreien Patienten bei jeder FFA-Dosis: nach Woche 11 (0,4mg/kg/Tag) / nach Woche 16 (0,8mg/kg/Tag)
    • Anzahl der anfallsfreien Tage pro Patient mit 0,4mg/kg/Tag: während der 4-wöchigen Behandlung (Woche 7-11)
    • Anzahl der anfallsfreien Tage pro Patient mit 0,8mg/kg/Tag: während der 4-wöchigen Behandlung (Woche 12-16)
    • Änderung der Anfallshäufigkeit pro Patient und pro Hauptanfalltyp (tonisch klonische Anfälle (TCS), tonische Anfälle (TS), atonische Anfälle (AS), fokale Anfälle (FS), myoklonische Anfälle (MS): nach Woche 11 (0.4mg/kg/Tag) / nach Woche 16 (0.8mg/kg/Tag)
    E.5.2Secondary end point(s)
    1) Quality of Life of add-on FFA in Myoclonic Astatic Epilepsy
    • CGI (clinical global impression) by caregiver and treating physician
    • Sleep quality (e.g. documentation with Karolinska daytime sleep scale)
    • Parent / caregiver 5-point scale questionnaire to assess the subjects´ development regarding cognition, motor, behavior, activity level
    2) Safety of add-on FFA in Myoclonic Astatic Epilepsy
    • Adverse events
    • Laboratory safety
    • Vital signs
    • Physical examination
    • Neurological examination
    • 12-lead electrocardiogram (ECGs)
    • Doppler echocardiogram (ECHOs)
    • Body weight
    1) Lebensqualität bei Zusatztherapie mit FFA bei myoklonischer astatischer Epilepsie
    • CGI (klinischer globaler Eindruck) durch Bezugsperson und behandelnder Arzt
    • Schlafqualität (z. B. Dokumentation mit der Tagesschlafskala von Karolinska)
    • 5-Punkte-Fragebogen für Eltern / Bezugspersonen zur Beurteilung der Entwicklung der Patienten in Bezug auf Kognition, Motorik, Verhalten, Aktivitätslevel
    2) Sicherheit der Zusatz-therapie mit FFA bei myoklonischer astatischer Epilepsie
    • Nebenwirkungen
    • Laborsicherheit
    • Vitalwerte
    • Körperliche Untersuchung
    • Neurologische Untersuchung
    • 12-Kanal-Elektrokardiogramm (EKG)
    • Doppler-Echokardiogramm (ECHOs)
    • Körpergewicht
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Quality of Life of add-on FFA in Myoclonic Astatic Epilepsy
    • CGI and 5-point developement questionnaire: baseline, week 11 (0.4mg/kg/d) / week 16 (0.8mg/kg/d), month 3 and 6 (in case of cardiac symptoms)
    • Sleep quality: baseline, week 11 (0.4mg/kg/d) / week 16 (0.8mg/kg/d)

    2) Safety of add-on FFA in Myoclonic Astatic Epilepsy
    • Adverse events: continous
    • Laboratory safety: baseline, week 11 (0.4mg/kg/d) / week 16 (0.8mg/kg/d)
    • Vital signs:baseline, week 4, week 11 (0.4mg/kg/d) / week 16 (0.8mg/kg/d)
    •ECG/Echo: baseline, week 11 (0.4mg/kg/d) / week 16 (0.8mg/kg/d), month 3 and 6 (in case of cardiac symptoms)
    1) Lebensqualität bei Zusatztherapie mit FFA bei myoklonischer astatischer Epilepsie
    • CGI und 5-Punkte-Entwicklungs-Fragebogen: baseline, Woche 11 (0.4mg/kg/d) / Woche 16 (0.8mg/kg/d), Monat 3 und 6 (im Fall kardieller Auffälligkeiten)
    • Schlafqualität: baseline, Woche 11 (0.4mg/kg/d) / Woche 16 (0.8mg/kg/d)

    2) Sicherheit der Zusatz-therapie mit FFA bei myoklonischer astatischer Epilepsie
    • Nebenwirkungen: kontinuierlich
    • Laborsicherheit: baseline, Woche 11 (0.4mg/kg/d) / Woche 16 (0.8mg/kg/d)
    • Vitalwerte: baseline, Woche 4, Woche 11 (0.4mg/kg/d) / Woche 16 (0.8mg/kg/d)
    •EKG/Echo: baseline, Woche 11 (0.4mg/kg/d) / Woche 16 (0.8mg/kg/d), Monat 3 und 6 (im Fall kardieller Auffälligkeiten)
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dosisfindung, Zusatztherapie
    Dose finding, add-on study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned 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: 10
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 7
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) No
    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 No
    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
    Children between 1 year and 17 years
    Minderjährige zwischen 1 Jahr und 17 Jahren
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Those subjects who have not responded at the end of the study and subjects who have been or have
    withdrawn from the study will receive further treatment according to the standard of care.
    All subjects who have completed the study and are responders will be offered to continue with the
    dosage they have responded to.
    Responders who refuse further treatment with Fenflurame will receive further treatment according
    to the standard of care.
    Die Studienteilnehmer, die am Ende der Studie nicht angesprochen haben, und Studienteilnehmer, die aus der Studie ausgetreten sind oder dihre Einwilligung zurückgezogen haben, werden gemäß Standard weiterbehandelt. Allen Studienteilnehmer, die die Studie abgeschlossen haben und Responder sind, wird angeboten, die Dosierung fortzusetzen, auf die sie angesprochen haben. Befragte, die eine weitere Behandlung mit Fenflurame ablehnen, werden nach Maßgabe der Pflegestandards weiterbehandelt.
    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 Decision2019-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-05
    P. End of Trial
    P.End of Trial StatusRestarted
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