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    Summary
    EudraCT Number:2020-002812-36
    Sponsor's Protocol Code Number:PTC743-NEU-003-FA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002812-36
    A.3Full title of the trial
    A Randomized, Parallel-Arm, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Friedreich ataxia (MOVE-FA)
    Studio controllato con placebo, randomizzato, a bracci paralleli, in doppio cieco, con estensione in aperto, per valutare l’efficacia e la sicurezza di vatiquinone per il trattamento dell’atassia di Friedreich (MOVE-FA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine if Vatiquinone, the study drug, is safe and effective to treat a neurological condition called Friedreich ataxia
    Studio per valutare l’efficacia e la sicurezza di vatiquinone in soggetti con atassia di Friedreich (Friedreich ataxia, FA).
    A.3.2Name or abbreviated title of the trial where available
    MOVE-FA
    MOVE-FA
    A.4.1Sponsor's protocol code numberPTC743-NEU-003-FA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04577352
    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 SponsorPTC THERAPEUTICS INC.
    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 supportPTC Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPTC Therapeutics, Inc.
    B.5.2Functional name of contact pointPatient Advocacy
    B.5.3 Address:
    B.5.3.1Street Address100 Corporate Court
    B.5.3.2Town/ citySouth Plainfield
    B.5.3.3Post codeNJ 07080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18662825873
    B.5.6E-mailmedinfo@ptcbio.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 nameVatiquinone
    D.3.2Product code [PTC743]
    D.3.4Pharmaceutical form Capsule
    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 INNVatiquinone
    D.3.9.1CAS number 1213269-98-7
    D.3.9.2Current sponsor codePTC743
    D.3.9.4EV Substance CodeSUB188275
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCapsule
    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
    Friedreich Ataxia (FA)
    Atassia di Friedreich
    E.1.1.1Medical condition in easily understood language
    Friedreich ataxia is an autosomal recessive, neurodegenerative disease that primarily affects the nervous system and heart.
    Atassia di Friedreich
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10017374
    E.1.2Term Friedreich's ataxia
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 the study is to evaluate the efficacy (using the modified Friedreich Ataxia Rating Scale [mFARS]) and safety of vatiquinone in subjects with FA.
    L’obiettivo primario dello studio è quello di valutare l’efficacia (usando la scala di valutazione dell’atassia di Friedreich modificata [mFARS]) e la sicurezza di vatiquinone in soggetti con atassia di Friedreich (Friedreich ataxia, FA).
    E.2.2Secondary objectives of the trial
    • Demonstrate the effects of vatiquinone on activities of daily living as assessed by the Friedreich Ataxia Rating Scale Activities of Daily Living (FARS-ADL) scale
    • Demonstrate the effects of vatiquinone on ambulation as assessed by the 1-minute walk test (1MWT)
    • Demonstrate the effects of vatiquinone on falls as assessed by a fall log
    Secondari
    • Dimostrare gli effetti di vatiquinone sulle attività giornaliere, valutati mediante la scala di valutazione della FA quanto allo svolgimento delle attività giornaliere (FARS-ADL)
    • Dimostrare gli effetti di vatiquinone sulla deambulazione, valutati mediante il test della camminata di 1 minuto (1MWT)
    • Dimostrare gli effetti di vatiquinone sulle cadute, valutati mediante un registro delle cadute
    Esplorativi
    • Dimostrare gli effetti di vatiquinone sul linguaggio mediante il protocollo di Redenlab
    • Dimostrare gli effetti di vatiquinone sull’affaticamento, valutati mediante la scala d’impatto dell’affaticamento modificata (MFIS)
    • Dimostrare gli effetti di vatiquinone sullo stato di salute mediante il questionario europeo sulla qualità della vita a 5 dimensioni con scala a 5 livelli (EQ-5D-5L)
    • Dimostrare gli effetti di vatiquinone sulla scala secondaria della stabilità in posizione eretta della mFARS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. mFARS =20 to =70 at baseline

    2. Minimum age 7 years at the time of Screening Visit

    3. Must be able to ambulate at least 10 feet in one minute with or without assistance (non-wheelchair)

    4. Friedreich ataxia diagnosis (homozygous for GAA repeat expansion in intron-1 of FXN gene), confirmed by clinical testing

    5. Consent to comply with study procedures. For subjects under the age of 18 (or age of consent), parent(s)/legal guardian(s) of the subject must agree to comply with the requirements of the study, including the need for frequent and prolonged follow-up; parent(s)/legal guardian(s) with custody of the subject must give their consent for subject to enroll in the study.

    6. Difference in the mFARS between screening and baseline of no more than 4 points
    o If the subject is taking prohibited medications (see exclusion criteria)
    at Screening, this difference is to be assessed between the
    post-discontinuation mFARS and the Baseline mFARS.

    7. Able to abstain from anticoagulants and any aspirin (including 81 mg) for 30 days prior to the Baseline Visit and for the duration of the study

    8. Ability to abstain from potent cytochrome P450 (CYP) 3A4 inducers/inhibitors (eg, ketoconazole, rifampin, St. John’s wort, grapefruit juice) for at least 4 weeks prior to enrollment

    9. Ability to swallow capsules

    10. Males and females of childbearing potential must be willing to use an effective method of contraception as defined in protocol Section 7.5.10 from the time consent is signed until 30 days after treatment discontinuation
    1. Punteggio mFARS compreso tra = 20 e = 70 al basale
    2. Età minima: 7 anni al momento della visita di screening
    3. Essere in grado di deambulare per almeno 3 metri in un minuto con o senza assistenza (soggetti che non fanno uso di sedia a rotelle)
    4. Diagnosi di atassia di Friedreich (omozigote per l’espansione della ripetizione guanina adenina-adenina [GAA] a livello dell’introne-1 del gene fratassina), confermata mediante test genetici clinici
    5. Consenso a sottoporsi alle procedure mediche dello studio. Per i soggetti di età inferiore a 18 anni (o età del consenso), il/i genitore/i o tutore/i legale/i del soggetto deve/ono accettare di attenersi ai requisiti dello studio, compresa la necessità di follow-up frequente e prolungato e, coloro che hanno l’affidamento del soggetto, devono prestare il proprio consenso per il suo arruolamento nello studio.
    6. Differenza del punteggio mFARS tra lo screening e il basale non superiore a 4 punti
    o Se il soggetto sta assumendo farmaci proibiti (v. criteri di esclusione) allo screening, tale differenza è da valutarsi tra il punteggio mFARS post-interruzione e quello del basale.
    7. Essere in grado di astenersi da anticoagulanti e qualsiasi tipo di aspirina (anche a una dose di 81 mg) per 30 giorni prima della visita basale e per tutta la durata dello studio
    8. Capacità di astenersi da potenti induttori/inibitori del citocromo P450 (CYP) 3A4 (ad es. ketoconazolo, rifampicina, erba di S. Giovanni, succo di pompelmo) per almeno 4 settimane prima dell’arruolamento
    9. Capacità di deglutire le capsule
    10. I soggetti di sesso maschile e femminile in età fertile devono essere disposti a utilizzare un metodo contraccettivo efficace (ad es. impianti, contraccettivi iniettabili, patch transdermico, contraccettivi orali, contraccettivi orali combinati, metodi barriera e dispositivi intrauterini) dal momento della firma del consenso fino ai 30 giorni successivi all’interruzione del trattamento. Nota: Si richiede il metodo a doppia barriera se non sono in uso altri metodi contraccettivi.
    E.4Principal exclusion criteria
    1. Individuals with clinical diagnosis of FA who have point mutations or deletions or other non-GAA expansion mutations

    2. Previous treatment with vatiquinone or allergy to vatiquinone, sesame oil, gelatin (bovine and/or porcine), titanium dioxide, or red iron oxide

    3. Ejection fraction <50%

    4. Uncontrolled diabetes (HbA1c >7.0%) at the time of screening

    5. Has current suicidal ideation or suicidal behavior based on Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or baseline

    6. Pregnant or lactating subjects or those sexually active subjects who are unwilling to comply with proper birth control methods; females of childbearing potential must have a negative pregnancy test at Screening and during the Baseline Visit

    7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2 x ULN at time of screening

    8. INR =1.5 x ULN at time of screening or clinically significant (CS) bleeding, as determined by the investigator

    9. Serum creatinine =1.5 x ULN at time of screening

    10. Comorbidities that may confound study results (eg, fat malabsorption syndrome, other mitochondrial disorder) in the opinion of the investigator

    11. Participation in any other interventional clinical trial or received any investigational drug in any other clinical trial within 60 days prior to the Baseline Visit. Subjects may be rescreened after the exclusionary period of 60 days has passed.

    12. Concomitant use of CoQ10, vitamin E, idebenone, or any other non-approved medication for FA within 30 days prior to the Screening Visit. These prohibited medications can be discontinued at the Screening Visit; if this is the case, the mFARS assessment must be repeated to confirm inclusion eligibility after a minimum of 30 days post-discontinuation and there must be no more than a 4-point difference in mFARS assessed from the Post-Discontinuation Visit to the Baseline Visit.
    1. Soggetti con diagnosi clinica di FA accompagnata da mutazioni puntiformi, delezioni o altre mutazioni di espansione non-GAA.
    2. Precedente trattamento con vatiquinone o allergia a vatiquinone, olio di sesamo, gelatina (bovina e/o suina), biossido di titanio oppure ossido di ferro rosso
    3. Frazione di eiezione < 50%
    4. Diabete non controllato (emoglobina glicata [HbA1c] > 7,0%) al momento dello screening
    5. Attualmente presenta dei comportamenti o delle ideazioni suicidari, come riscontrato tramite la scala della Columbia University per la valutazione della gravità del rischio di suicidio (C-SSRS) allo screening o al basale.
    6. Soggetti attualmente in gravidanza o che allattano al seno o soggetti sessualmente attivi che non sono disposti a usare metodi contraccettivi adeguati; i soggetti di sesso femminile in età fertile devono presentare un test di gravidanza negativo allo screening e in occasione della visita basale
    7. Aspartato aminotransferasi o alanina aminotransferasi = 2 x limite superiore della norma (ULN) al momento dello screening
    8. Rapporto normalizzato internazionale = 1,5 x ULN al momento dello screening o sanguinamento clinicamente significativo, determinato dallo sperimentatore
    9. Creatinina sierica = 1,5 x ULN al momento dello screening
    10. Comorbilità che potrebbe interferire con i risultati dello studio (ad es. sindrome da malassorbimento dei grassi, altro disturbo mitocondriale) stando all’opinione dello sperimentatore
    11. Partecipazione ad altra sperimentazione clinica interventistica o trattamento con qualsiasi farmaco sperimentale oggetto di un’altra sperimentazione clinica nei 60 giorni precedenti alla visita basale. I soggetti potranno essere nuovamente sottoposti a screening, una volta trascorso un periodo di 60 giorni che comporta l’esclusione.
    12. Uso concomitante di CoQ10, vitamina E, idebenone o qualsiasi altro farmaco non approvato per la FA nei 30 giorni precedenti alla visita di screening. Questi farmaci proibiti possono essere interrotti alla visita di screening; in tal caso, bisogna ripetere la valutazione mFARS per confermare l’idoneità all’inclusione almeno 30 giorni dopo l’interruzione e la differenza del punteggio mFARS tra la visita post-interruzione e la visita basale non deve essere superiore a 4 punti.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the change from baseline in the modified Friedreich Ataxia Rating Scale (mFARS) in the mITT population at Week 72.
    Primario
    Variazione rispetto al basale del punteggio mFARS alla Settimana 72
    E.5.1.1Timepoint(s) of evaluation of this end point
    A completer analysis will be performed for all subjects who took medication till the end of double-blind period as specified by the protocol and have mFARS score at Week 72 visit.
    72 settimane
    E.5.2Secondary end point(s)
    Secondary endpoints will include change in baseline in the following assessments at Week 72.
    • FARS-ADL scale (key secondary endpoint)
    • 1MWT
    • Fall log
    Secondari
    Gli endpoint secondari includeranno la variazione rispetto al basale delle seguenti valutazioni alla Settimana 72:
    • Scala FARS-ADL (endpoint secondario principale)
    • 1MWT
    • Registro delle cadute
    Esplorativi
    Gli endpoint esplorativi includeranno la variazione rispetto al basale nelle seguenti valutazioni alla Settimana 72:
    • Linguaggio, mediante il protocollo di Redenlab
    • MFIS
    • EQ-5D-5L
    E.5.2.1Timepoint(s) of evaluation of this end point
    Comparisons between treatment groups for change from baseline in FARS-ADL scale, one minute timed walk, MFIS score, EQ-5D-5L, and Upright Stability subscale of the mFARS to Week 72 will be analyzed using the same model as the primary efficacy variable by using its respective baseline and age as covariates. Summary statistics will be provided for total score at each visit as well as change from baseline at each visit.

    A summary of the number of falls will be presented, and the number of falls over time will be compared between the two treatment groups.
    72 settimane
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    Studio con estensione in aperto
    Study with Open-Label Extension
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Information not present in EudraCT
    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
    Brazil
    Canada
    United States
    France
    Germany
    Italy
    Spain
    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
    La durata massima del trattamento per ogni soggetto sarà di 96 settimane (includendo la fase controllata con placebo e la fase di estensione). La durata complessiva dello studio sarà al massimo di 106 settimane circa per ogni soggetto. I soggetti che completano lo studio avranno la possibilità di entrare in un programma di accesso allargato in aperto per proseguire il trattamento con vatiquinone.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 126
    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)
    Subjects who complete the study may have the option to enter an open-label expanded access program to continue receiving vatiquinone.
    La durata complessiva dello studio sarà al massimo di 106 settimane circa per ogni soggetto. I soggetti che completano lo studio avranno la possibilità di entrare in un programma di accesso allargato in aperto per proseguire il trattamento con vatiquinone.
    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 Decision2021-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-26
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