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    Summary
    EudraCT Number:2016-002107-26
    Sponsor's Protocol Code Number:EP0078
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-12
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-002107-26
    A.3Full title of the trial
    AN OPEN-LABEL ADAPTIVE STUDY FOR THE ASSESSMENT OF SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MULTIPLE DOSES OF RADIPRODIL IN SUBJECTS WITH DRUG-RESISTANT INFANTILE SPASMS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 study of Radiprodil in subjects with drug-resistant infantile spasms (IS)
    A.4.1Sponsor's protocol code numberEP0078
    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 SponsorUCB Biopharma SPRL
    B.1.3.4CountryBelgium
    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 supportUCB BIOPHARMA SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameRadiprodil
    D.3.2Product code UCB3491
    D.3.4Pharmaceutical form Granules for oral suspension
    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 INNRadiprodil
    D.3.9.1CAS number 496054-87-6
    D.3.9.2Current sponsor codeUCB3491
    D.3.9.4EV Substance CodeSUB178336
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.04 to 0.21
    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
    Infantile spasms (IS)
    E.1.1.1Medical condition in easily understood language
    Infantile spasms is a rare and severe epilepsy condition in which children experience a specific type of seizure (spasm) along with abnormal brain activity
    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 10021750
    E.1.2Term Infantile spasms
    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
    Part A:
    - Evaluate the safety and tolerability of radiprodil in subjects with drug-resistant infantile spasms
    - Evaluate the pharmacokinetics of radiprodil in subjects with drug-resistant infantile spasms
    - Evaluate the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms

    Part B:
    - Evaluate the efficacy of radiprodil in abolishing clinical spasms and achieving the resolution of hypsarrhythmia (or other disordered interictal electroencephalogram (EEG) patterns consistent with the
    diagnosis) in subjects with drug-resistant infantile spasms
    - Evaluate the safety and tolerability of radiprodil in subjects with drug-resistant infantile spasms

    Part C:
    - Investigate the safety and tolerability of radiprodil over repeated treatment cycles
    - Investigate the efficacy of radiprodil in infants who have responded to 2 treatment cycles in Part A but experienced a relapse within 3 days of treatment cessation
    E.2.2Secondary objectives of the trial
    Part A:
    - Evaluate resolution of hypsarrhythmia (or other disordered interictal EEG patterns consistent with the diagnosis) in subjects with drug-resistant infantile spasms
    - Evaluate long-term developmental outcomes after treatment with radiprodil in subjects with drug-resistant infantile spasms

    Part B:
    - Evaluate the pharmacokinetics of radiprodil in subjects with drug-resistant infantile spasms
    - Evaluate long-term development outcomes after treatment with radiprodil in subjects with drug-resistant infantile spasms

    Part C:
    - Evaluate long-term developmental outcomes after repeated treatment cycles of radiprodil
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Parts A and B:
    - Subject is male or female between 2 and 14 months of age
    - The diagnosis of infantile spasms (IS)
    - Subject has drug-resistant IS

    Part C:
    - Subject participated in EP0078 Part A and received 2 radiprodil treatment cycles
    - Subject experienced a relapse of spasms during the down taper or within 5 half-lives (3 days) discontinuation of radiprodil treatment in Cycle 2 of Part A
    - Electroencephalogram (EEG) on baseline Part C is compatible with the
    diagnosis of infantile spasms
    E.4Principal exclusion criteria
    Parts A and B:
    - More than 6 months have passed since the diagnosis of IS.
    - Subject has hematocrit greater than 60
    - Subject has any medical condition that, in the opinion of the Investigator, could jeopardize or would
    compromise the subject’s ability to participate in this study
    - Subject has a history or current condition predisposing to respiratory dysfunction
    - Current treatment with felbamate
    - Ketogenic diet
    - Clinically significant lab abnormalities
    - Clinically significant abnormality on ECG that, in the opinion of the Investigator, increases the safety risks of participating in the study
    - Subject has a lethal or potentially lethal condition other than IS, with a significant risk of death before 18 months of age
    - Body weight is below 4 kg
    - Known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias
    - Current treatment with perampanel
    - Current treatment with cannabinoids

    Part C:
    - Subject experienced any acute tolerability issues in either treatment cycle in Part A which the investigator and the sponsor medical monitor consider a risk for further participation
    - Subject met any withdrawal criteria in Part A
    - Subject has experienced any adverse effects or developed any new medical conditions since enrollment in Part A which the investigator considers could significantly increase the safety risks of participating in Part C
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    - Percentage of subjects with clinical response on day 14 of treatment with the maintenance dose of radiprodil

    Part B:
    - Percentage of subjects with electro-clinical response on day 14 of treatment with the maintenance dose of radiprodil

    All Parts:
    - Incidence of Adverse Events (AEs) during the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A:
    - Day 14, counting from the first day of radiprodil at maintenance dose
    - Pharmacokinetic samples will be collected using Mitra microsampling technique at baseline (this sample may be taken at any time during Day -14 to Day -1 prior to dosing) and 3hr, 4hr, 5hr and 12hr after the first dose on Day 1 of radiprodil low dose, Day 1 of radiprodil mid dose and Day 1 of radiprodil high dose, Additionally, blood samples will be taken at same timepoints after 1st dose on Day 2 of radiprodil low dose"

    Part B:
    - Day 14, counting from the first day of radiprodil at maintenance dose

    All Parts: From Baseline (Day -1) to the end of the Post-treatment Period
    (28 days post last dosing)
    E.5.2Secondary end point(s)
    Part A:
    - Percentage of subjects with electro-clinical response on day 14 of treatment with the maintenance dose of radiprodil

    Part B:
    - Percentage of subjects with clinical response on day 14 of treatment with the maintenance dose of radiprodil

    Part A and Part B:
    - Time to cessation of spasms
    - Percentage of responders with clinical relapse
    - Time to clinical relapse from the day of spasm cessation
    - Percentage of electro-clinical responders with electro-clinical relapse
    - Time to electro-clinical relapse from the day of spasm cessation
    - Percentage of subjects with extended clinical response
    - Percentage of subjects with extended electro-clinical response
    - Estimates of exposure generated from a population-Pharmacokinetic
    modelling

    Part C:
    - Percentage of subjects with extended clinical response to each
    additional treatment cycle on Day 14 of treatment with the maintenance
    dose of radiprodil
    - Number of treatment cycles per subject
    - Percentage of subjects with electro-clinical response to each additional treatment cycle on Day 14 of treatment with the maintenance dose of radiprodil
    - Time to clinical relapse from the first day of no witnessed spasms for each treatment cycle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A and B:
    - Day 14, counting from Day 14 of treatment with the maintenance dose of radiprodil
    - During the first 14 days of treatment with radiprodil
    - 12 months, counting from Day 14 of treatment with the maintenance dose of radiprodil
    - From day of spasms cessation up to 42 months of age
    - 28 days, counting from Day 14 (incl) of maintenance dose

    Part B:
    - Pharmacokinetic samples will be collected on Day 1 of radiprodil low dose, mid dose and high dose. Additionally, blood samples will be taken after 1st dose on Day 2 of radiprodil low dose

    Part C:
    - 28 days, counting from Day 14 (incl.) of maintenance dose
    - During Part C (Day -1 to Day 28 of the Maintenance Period)
    - Day 14, counting from the first day of maintenance dose
    - From day of no witnessed spasms up to 42 months of age
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    France
    Germany
    United Kingdom
    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
    Last Subject Last Visit (LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial 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 Yes
    F.1.1Number of subjects for this age range: 60
    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: 60
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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
    This trial includes infants with a minimal age of 2 months and a maximal age of 14 months. An Institutional Review Board/Independent Ethics Committee approved written Informed Assent form is signed and dated by the parent(s) or legal representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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)
    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 Decision2016-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-02
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