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    Summary
    EudraCT Number:2020-003231-19
    Sponsor's Protocol Code Number:ViRap
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-10-09
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-003231-19
    A.3Full title of the trial
    Randomized, placebo-controlled, double-blind and double-dummy clinical trial comparing the safety, tolerability, and efficacy of vigabatrin and rapamycin in a preventive treatment of infants with Tuberous Sclerosis Complex (ViRap)
    Randomizowane badanie kliniczne kontrolowane placebo, prowadzone metodą podwójnie ślepej i podwójnie pozorowanej próby, oceniające skuteczność, tolerancję i bezpieczeństwo leczenia wigabatryną w stosunku do leczenia rapamycyną jako terapii zapobiegawczej u niemowląt ze stwardnieniem guzowatym (ViRap)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy and safety of rapamycin versus vigabatrin in the prevention of Tuberous Sclerosis Complex symptoms in infants in the randomized clinical trial
    Porównanie skuteczności i bezpieczeństwa wigabatryny i rapamycyny w zapobieganiu objawom stwardnienia guzowatego u niemowląt w randomizowanym badaniu klinicznym
    A.3.2Name or abbreviated title of the trial where available
    ViRap
    ViRap
    A.4.1Sponsor's protocol code numberViRap
    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 SponsorThe Children's Memorial Health Institute
    B.1.3.4CountryPoland
    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 supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Children's Memorial Health Institute
    B.5.2Functional name of contact pointKatarzyna Kotulska-Jóźwiak
    B.5.3 Address:
    B.5.3.1Street AddressAv. Dzieci Polskich 20
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code04-730
    B.5.3.4CountryPoland
    B.5.4Telephone number48228157460
    B.5.6E-mailk.kotulska@ipczd.pl
    D. IMP Identification
    D.IMP: 1
    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 500 mg, granules for oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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.3.4Pharmaceutical 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.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 RAPAMUNE 1 mg/ml oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Oral solution
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral liquid
    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 placeboOral powder
    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
    Tuberous Sclerosis Complex
    Epilepsy
    Tumors associated with Tuberous Sclerosis Complex
    Stwardnienie guzowate
    Padaczka
    Guzy narządowe związane ze stwardnieniem guzowatym
    E.1.1.1Medical condition in easily understood language
    Tuberous Sclerosis Complex
    Epilepsy
    Tumors associated with Tuberous Sclerosis Complex
    Stwardnienie guzowate
    Padaczka
    Guzy związane ze stwardnieniem guzowatym
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the ViRap study is to investigate safety and efficacy of rapamycin versus vigabatrin in the preventive treatment of infants with TSC.
    The primary epilepsy-related objective of the study is to compare the risk of developing epileptic seizures during the blinded phase of the study in the group receiving vigabatrin and the group receiving rapamycin. The primary tumor -related objective of the ViRap study is to compare the risk of new or increasing tumors in the group receiving rapamycin and the group receiving vigabatrin in the blinded phase of the study.
    Celem badania ViRap jest porównanie bezpieczeństwa i skuteczności wigabatryny i rapamycyny w leczeniu profilaktycznym niemowląt ze stwardnieniem guzowatym. W odniesieniu do padaczki, pierwszorzędowym celem badania jest porównanie ryzyka wystąpienia napadów klinicznych w czasie trwania fazy zaślepionej badania u pacjentów otrzymujących rapamycynę lub wigabatrynę. W odniesieniu do guzów pierwszorzędowym celem badania jest porównanie ryzyka wzrostu istniejących guzów lub pojawienie się nowych zmian tego typu w czasie trwania fazy zaślepionej badania u pacjentów otrzymujących rapamycynę lub wigabatrynę.
    E.2.2Secondary objectives of the trial
    The secondary objective of the Virap study is to compare the safety profile of vigabatrin and rapamycin in infants with TSC and the comparison of severity of epilepsy and its neuropsychiatric comorbidities, as well as changes in the size of TSC-associated tumors in patients receiving rapamycin and vigabatrin. Additionally, the impact of treatment on the quality of life of patients receiving rapamycin or vigabatrin will be compared.
    Drugorzędowe cele badania ViRap obejmują porównanie profilu bezpieczeństwa leczenia wigabatryną lub rapamycyną u niemowląt ze stwardnieniem guzowatym oraz porównanie ciężkości padaczki i jej powikłań neuropsychiatrycznych, a także parametrów zmian rozmiarów guzów związanych ze stwardnieniem guzowatym u dzieci leczonych wigabatryna lub rapamycyną. Ponadto porównane zostaną wyniki badania jakości życia pacjentów otrzymujących wigabatryne lub rapamycynę.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ViRap Biomarker Study: Analysis of biomarkers of epileptogenesis and tumorigenesis in the cerebrospinal fluid in TSC infants receiving rapamycin or vigabatrin in the Virap study.
    Badanie biomarkerów w projekcie ViRap: analiza biomarkerów epileptogenezy i rozwoju guzów w płynie mózgowo-rdzeniowym dzieci leczonych rapamycyną lub wigabatryną w ramach badania ViRap.
    E.3Principal inclusion criteria
    For the inclusion in the study, patients must fulfil all the following inclusion criteria:
    - Male or female aged from 4 up to 16 weeks (41-56 weeks of gestational age) at the day of randomization
    - Parents/caregivers are willing to and able to give informed consent form for the participation in the study
    - Parents/caregivers are willing to and able to comply with all study requirements
    - Definite diagnosis of TSC according to the Consensus criteria (Northrup,2013)
    - At least 1 focus of cortical dysplasia disclosed on brain MRI
    Kryteria włączenia do badania ViRap obejmują:
    - niemowlę płci żeńskiej lub męskiej, w wieku między 4 a 16 tygodni (41-56 tygodni wieku korygowanego) w momencie randomizacji,
    - świadoma zgoda rodziców/opiekunów pacjenta na udział w badaniu klinicznym
    - deklaracja rodziców/opiekunów pacjenta o możliwości i chęci przestrzegania protokołu badania,
    - pewne rozpoznanie stwardnienia guzowatego w oparciu o międzynarodowe kryteria (Northrup, 2013),
    - co najmniej 1 zmiana o charakterze dysplastycznym w mózgu widoczna w badaniu MRI.
    E.4Principal exclusion criteria
    Patient may not enter the study if any of the following exclusion criteria are met:
    - history of seizures prior to randomization
    - history of antiepileptic treatment
    - history of treatment with mTOR inhibitor,
    - gestational age below 41 weeks at the day of randomization
    - body weight lower than 3 kg at the day of randomization
    - SEGA or other TSC- associated lesion requiring urgent surgical intervention
    - recent surgery within 1 month prior to the randomization
    - intercurrent infection at the date of randomization
    - known history of HIV seropositivity
    - live vaccination within 4 weeks prior to randomization
    - lack of first TBC and hepatitis B vaccinations
    - Any significant clinical, laboratory , ECG or other abnormalities, comorbidity or concomitant treatment which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study.
    - Use of an investigational drug within 1 month prior to randomization
    Kryteria wykluczające udział pacjenta w badaniu ViRap obejmują:
    - napady padaczkowe kiedykolwiek w życiu,
    - leczenie przeciwpadaczkowe kiedykolwiek w życiu,
    - leczenie inhibitorem mTOR kiedykolwiek w życiu
    - korygowany wiek poniżej 41 tygodni w momencie randomizacji,
    - masa ciała niższa niż 3 kg w momencie randomizacji,
    - zabieg operacyjny w miesiącu poprzedzającym randomizację,
    - aktywna infekcja w momencie randomizacji,
    - znany nieprawidłowy wynik badania serologicznego w kierunku HIV,
    - szczepienie żywą szczepionka w okresie 4 tygodnia przed randomizacją,
    - niezaszczepienie przeciwko gruźlicy lub pierwszą dawką szczepienia przeciwko wzwB,
    - jakiekolwiek kliniczne, laboratoryjne, elektrofizjologiczne nieprawidłowości lub choroby towarzyszące, które w opinii lekarza prowadzącego leczenie mogą narażać pacjenta na dodatkowe ryzyko związane z udziałem w badaniu lub które mogą wpływać na wyniki badania,
    - stosowanie leku eksperymentalnego w okresie miesiąca poprzedzającego randomizację.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of the ViRap study are:
    - occurrence of clinical seizures in the blinded phase of the study
    - increase in summarized volume of TSC-associated tumors ≥ 25% of initial value within the blinded phase of the study.
    Pierwszorzędowe punkty końcowe w badaniu ViRap obejmują:
    - wystąpienie napadów padaczkowych klinicznych w fazie zaślepionej badania
    - wzrost objętości guzów narządowych związanych ze stwardnieniem guzowatym na zakończenie fazy zaślepionej badania o 25% w porównaniu z wynikiem wyjściowym
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoints will be assessed at the end of the blinded phase of the study (not later than on Day730)
    Pierwszorzędowe punkty końcowe będą analizowane na zakończenie zaślepionej fazy badania (najpóźniej w dniu 730).
    E.5.2Secondary end point(s)
    The secondary endpoints include:
    - total volume of TSC-associated tumors within the blinded phase and the whole study
    - the risk for high risk of autism assessed with psychological test (ADOS) at the end of the study
    - the risk for low developmental quotient (< 70 points in Bayley Scales of Infant Development,) at the end of the study,
    - the risk of drug-resistant epilepsy at any point of the study,
    - occurrence of adverse events within the blinded phase of the study,
    - number of adverse events across the whole study
    - parameters of physical development (weight and height gain history) across the whole study.
    Drugorzędowe punkty końcowe w badaniu ViRap obejmują:
    - zmianę całkowitej objętości narządowych guzów związanych ze stwardnieniem guzowatym na zakończenie fazy zaślepionej badania oraz na zakończenie całego badania
    - ryzyko wystąpienia autyzmu mierzone wynikiem skali ADOS na zakończenie fazy zaślepionej oraz na zakończenie całego badania
    - ryzyko wystąpienia opóźnienia psychoruchowego mierzone wynikiem poniżej 70 punktów w skali Bayley'a na zakończenie fazy zaślepionej oraz na zakończenie całego badania
    - ryzyko wystąpienia padaczki lekoopornej w czasie trwania badania
    - wystąpienie zdarzeń niepożądanych w zaślepionej fazie badania
    - liczbę zdarzeń niepożądanych w czasie trwania badania
    - parametry rozwoju fizycznego uczestników badania (wzrost i waga) w czasie trwania badania
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be analyzed respectively:
    - at the end of the blinded phase of the study (not later than on Day730)
    - at the end of the study (not later than on Day 730)
    - at multiple timepoints during the study.
    Drugorzędowe punkty końcowe będą oceniane odpowiednio:
    - na zakończenie zaślepionej fazy badania (najpóźniej w dniu 730)
    - na zakończenie całego badania (najpóźniej w dniu 730)
    - w wielu punktach kontrolnych w czasie trwania badania.
    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 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
    In the ViRap study, he impact of the treatment with vigabatrin or rapamycin on the biomarkers of epilepsy and tumorigenesis in TSC will be studied.
    W badaniu ViRap badany będzie również wpływ leczenia rapamycyną lub wigabatryną na biomarkery padaczki i nowotworzenia w TSC.
    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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 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
    Ostatnia wizyta ostatniego pacjenta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days5
    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
    Only infants aged 1-4 months will be eligible for the participation in the ViRap study. Their parents/caregivers will be asked to give the informed consent.
    Do badania ViRap włączane będą niemowlęta w wieku od 1 do 4 miesięcy. O udzielenie zgody na udział w badaniu będą proszeni ich rodzice/opiekunowie.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    The double-blinded phase of the trial will be followed by an open-label phase. In this phase, the patients will receive standard treatment adjusted to their clinical status and according to the international guidelines for the management of TSC. This treatment will be continued after the completion of the study.
    Po zakończeniu fazy podwójnie zaślepionej badania ViRap pacjenci włączani będą do fazy otwartej, w której leczenie będzie dostosowywane do indywidulnej sytuacji klinicznej pacjenta, zgodnie z międzynarodowymi wytycznymi postepowania w TSC. Postępowanie takie będzie kontynuowane po zakończeniu badania klinicznego.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Transition Technologies–Science sp. z o. o.
    G.4.3.4Network Country Poland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-08
    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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