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    The EU Clinical Trials Register currently displays   43233   clinical trials with a EudraCT protocol, of which   7153   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-000360-17
    Sponsor's Protocol Code Number:TGO-VGB-III-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2015-06-17
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-000360-17
    A.3Full title of the trial
    Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy.
    Observational, descriptive, open-label, multi-centric, non-randomized study
    Etude d’acceptabilité d’une nouvelle forme pédiatrique de la vigabatrine chez l’enfant atteint de spasmes infantiles ou d’épilepsie partielle pharmaco-résistante. Etude multicentrique, observationnelle, descriptive, non randomisée, en ouvert.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acceptability study of a new paediatric form of vigabatrin in infants and children with infantile spasms or pharmaco-resistant partial epilepsy.
    Etude d’acceptabilité d’une nouvelle forme pédiatrique de la vigabatrine chez l’enfant atteint de spasmes infantiles ou d’épilepsie partielle pharmaco-résistante.
    A.3.2Name or abbreviated title of the trial where available
    SOLUWEST
    SOLUWEST
    A.4.1Sponsor's protocol code numberTGO-VGB-III-01
    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 SponsorTARGEON
    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 supporttargeon
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportANR BIOTECS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre d'Investigation Clinique, HCL Lyon
    B.5.2Functional name of contact pointBehrouz KASSAI KOUPAI
    B.5.3 Address:
    B.5.3.1Street AddressBâtiment les Tilleuls, 59 boulevard Pinel
    B.5.3.2Town/ cityBron Cedex
    B.5.3.3Post code69677
    B.5.3.4CountryFrance
    B.5.4Telephone number33427 85 77 32
    B.5.5Fax number33472 35 73 64
    B.5.6E-mailbehrouz.kassai-koupai@chu-lyon.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 namevigabatrin
    D.3.2Product code VGB-ST
    D.3.4Pharmaceutical form Soluble tablet
    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 INNVIGABATRIN
    D.3.9.1CAS number 60643-86-9
    D.3.9.2Current sponsor codeVGB-ST
    D.3.9.3Other descriptive nameVGB-ST soluble tablets
    D.3.9.4EV Substance CodeSUB00048MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 500
    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 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 Sabril "granules for oral use"
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    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 Yes
    D.2.5.1Orphan drug designation numberORPHA 35294
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Granules for oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 and pharmaco-resistant partial epilepsy
    spasmes infantiles et épilepsie partielle pharmacorésistante
    E.1.1.1Medical condition in easily understood language
    Infantile spasms and pharmaco-resistant partial epilepsy
    spasmes infantiles et épilepsie partielle pharmacorésistante
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10021750
    E.1.2Term Infantile spasms
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10065336
    E.1.2Term Partial epilepsy
    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 describe the adherence to a new vigabatrin formulation (soluble tablets).
    E.2.2Secondary objectives of the trial
    1)Evaluate the palatability and the ease of use of the new vigabatrin formulation.
    2)Describe the adherence to Sabril and the new formulation (by treatments accountability)
    3)Evaluate the pharmacokinetic parameters of the new vigabatrin formulation.
    4)Evaluate the treatment safety, including the visual safety (by electroretinogram).
    5)Evaluate the taurine plasma concentrations in children treated with vigabatrin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Boys and girls.
    - Patients with diagnosed infantile spasms (IS) or pharmaco-resistant partial onset seizures (POS).
    - Infants > 1 month and < 6 months; infants > 6 months and < 2 years; and children > 2 years and < 6 years.
    - Patients stabilized under Sabril® for at least 2 weeks prior to V1: patients with no spasms/POS or with a stable frequency of spasms/POS (i.e. with no more than 50% variation in the number of spasms/POS) within 2 weeks prior to V1.
    - Patients under a twice-a-day posology of Sabril®.
    - Subjects covered by or having the rights to social security.
    - Signed informed consent and/or child assent.
    E.4Principal exclusion criteria
    - Change in anti-epileptic treatment and/or Sabril® dose within 7 days before V1.
    - Use of more than 2 other antiepileptic drugs as concomitant treatment (including steroids). Ketogenic diet can be in addition to these 2 other antiepileptic drugs.
    - Subjects receiving vigabatrin through a gastric tube.
    - Weight < 4 Kgs.
    - Any planned major surgery within the duration of the trial.
    - Participation in any other clinical trial within 3 months prior to V1.
    - Lack of ability or willingness to give informed consent.
    - Anticipated non-availability for study visits / procedures.
    - Lack of willingness or inability to co-operate adequately.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of adherent patients for the new VGB formulation. Adherence will be assessed by measurement of the dosing history of patients using an electronic Medication Event Monitoring System (MEMS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous endpoint between D15 and D98, 12 weeks under VGB-ST.
    E.5.2Secondary end point(s)
    - Adherence by accountability of Treatment units for the new ST formulation (number of tablets) and to Sabril® “granules for oral solution” (number of sachets).
    - Palatability evaluated using a two face visual hedonic scale filled in by the parents and/or by the child, if feasible, on a daily basis. Each “face” of the scale will be assigned a score (1 to 2), and the average score will be calculated for the group. Palatability will be considered good if the average score for the group is at least 1.5 out of a maximum of 2.
    - Ease of use will be evaluated for Sabril® « granules for oral solution » and for the new ST formulation using two diaries filled by the parents or care-givers during 7 consecutive days. Time required for preparation of both VGB ST and Sabril® administrations will be averaged and compared, together with the global use satisfaction .
    - Safety measures include:
    o Results of electroretinogram (when available).
    o General safety, including:
    • blood cells count, blood electrolytes, blood ionogram, serum creatinine, liver function assessment
    • vital signs (cardiac frequency and blood pressure)
    • adverse events and serious adverse events.
    - Pharmacokinetic parameters for the new ST formulation (population PK) : AUC, T max, Cmax, T½, Ka, V/F, Cl/F .
    - Taurine plasma concentration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Accountability : D1 to D14 under Sabril ; D15 to D98 under VGB-ST.
    - Palatability and ease of use, 7 consecutive days :D8 to D14 for Sabril® ; D22 to D28 under VGB-ST.
    - Safety measures :
    • blood assessment at V1 and V4,
    • vital signs at V1, V2, V4 and V5.
    • AE and SAE at each study visit.
    - Pharmacokinetic:
    • After V3, the same day, 1 sample just before treatment and 1 sample 1h after treatment.
    • At least 1 week before V4, the same day, 1 sample 3 to 5h after treatment and 1 sample 6 to 9 h after treatment.
    • At V4, 1 sample just before treatment and 1 sample 2h after treatment.
    - Taurine concentration at V4 fasting.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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
    palatability study, adherence
    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) 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 concerned12
    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 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 years0
    E.8.9.1In the Member State concerned months12
    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: 50
    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: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    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
    children from 1 month to 6 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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
    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 Decision2014-04-29
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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