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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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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    EudraCT Number:2013-003771-35
    Sponsor's Protocol Code Number:UX007G-CL201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-003771-35
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of UX007 in Subjects with Glucose Transporter Type 1 Deficiency Syndrome
    Un ensayo clínico doble ciego, controlado con placebo, de grupos paralelos para evaluar la seguridad y la eficacia de UX007 en sujetos con síndrome por deficiencia del transportador de glucosa de tipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to assess the safety and efficacy of UX007 in patients with Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)
    Un ensayo para estudiar la seguridad y la eficacia de UX007 en paciente con con síndrome por deficiencia del transportador de glucosa de tipo 1
    A.4.1Sponsor's protocol code numberUX007G-CL201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01993186
    A.5.4Other Identifiers
    Name:EMA/190573Number:Unique Product Identifier (UPI)
    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 SponsorUltragenyx Pharmaceutical 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 supportUltragenyx Pharmaceutical Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUltragenyx Pharmaceutical Inc
    B.5.2Functional name of contact pointJulia Martinisi
    B.5.3 Address:
    B.5.3.1Street Address60 Leveroni Court
    B.5.3.2Town/ cityNovato
    B.5.3.3Post codeCA 94949
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034658271136
    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 nameTriheptanoin / Triheptanoina
    D.3.2Product code UX007
    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 INNNot available
    D.3.9.1CAS number 620-67-7
    D.3.9.2Current sponsor codeUX007
    D.3.9.3Other descriptive nameTRIHEPTANOIN
    D.3.9.4EV Substance CodeSUB129584
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 solution
    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
    Glucose Transporter Type 1 deficiency syndrome
    síndrome por deficiencia del transportador de glucosa de tipo 1
    E.1.1.1Medical condition in easily understood language
    Glucose transporter type 1 (Glut1) deficiency syndrome is a rare genetic metabolic disorder characterized by deficiency of a protein that is required for glucose to cross the blood-brain barrier
    El síndrome por deficiencia del transportador de glucosa de tipo 1 (Glut1) es una enfermedad metabólica rara caracterizada por la falta de una proteina necesaria para que la glucosa llegue al cerebro
    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 HLGT
    E.1.2Classification code 10039911
    E.1.2Term Seizures (incl subtypes)
    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
    Primary Objectives:
    - Evaluate the efficacy of UX007 compared to placebo (between Weeks 2 and 8 of treatment), as measured by the reduction from the Baseline Period frequency of generalized or partial onset seizures
    - Evaluate the efficacy of UX007 compared to placebo in reducing the total frequency of absence seizures
    - Evaluate the safety of UX007 via adverse event (AE) rates, laboratory values, and electrocardiogram (ECG)
    -Evaluar la eficacia de UX007 en comparación con un placebo (entre las Semanas 2 y 8 del tratamiento), medida por la reducción desde la frecuencia de crisis convulsivas generalizadas o de crisis convulsivas de inicio parcial durante el Período de Referencia
    -Evaluar la eficacia de UX007 en comparación con un placebo en la reducción de la frecuencia total de crisis de ausencia
    -Evaluar la seguridad de UX007 por medio de tasas de eventos adversos (AE, por sus siglas en inglés), valores de laboratorio y electrocardiogramas (ECG)
    E.2.2Secondary objectives of the trial
    * Evaluate the efficacy of UX007 compared to placebo, as measured by:
    - Seizure response rate, defined as the % of subjects with at least 50% reduction from baseline period in generalized or partial-onset seizures, including absence seizures
    - Frequency of generalized or partial-onset seizures, including absence seizures
    - Change from randomization to Wk 8 in cognitive function using the Cambridge Neuropsychological Test Automated Battery
    - Change from randomization to Wk 8 in distance walked as measured by 6MWT
    - Time to onset of paroxysmal exertional dyskinesia as measured during 6MWT from randomization to Wk 8
    - Change from randomization to Wk 8 in gross motor function using the Gross Motor Function Measure-88
    * Evaluate long term efficacy as measured by changes from baseline in frequency of generalized or partial-onset seizures through Wk 52
    * Evaluate the optimal dose to control seizures and impact on other clinical manifestations during the Dose Exploration Period
    * Evaluar la eficacia de UX007 en comparación con placebo, medido por:
    - Tasa de respuesta a crisis convulsivas, definidas como el porcentaje de sujetos con una reducción de al menos el 50% a partir del Período de Referencia en crisis convulsivas
    - Frecuencia de crisis convulsivas
    - Cambio desde la aleatorización hasta la Semana 8 en función cognitiva,
    - Cambio desde la aleatorización hasta la Semana 8 en distancia caminada
    - Tiempo hasta aparición de discinecia paroxística inducida por ejercicio medido durante 6MWT desde la aleatorización hasta la Semana 8
    - Cambio desde la aleatorización hasta la Semana 8 en la motricidad gruesa
    *Evaluar la eficacia a largo plazo medida por los cambios desde el punto de referencia en la frecuencia de las crisis convulsivas
    * Evaluar la dosis óptima para controlar las crisis convulsivas y tener un impacto sobre otras manifestaciones clínicas durante el Período de Exploración de Dosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Diagnosis of Glut1 DS confirmed by SLC2A1 mutation
    2) Males and females, aged 1-35 years (inclusive) at the time of informed consent
    3) Average of at least 2 observable seizures (generalized or partial-onset [simple partial motor, complex partial, absence, or secondarily generalized] seizures) in 4 weeks over the last 24 weeks, by subject or caregiver report
    4) At least 2 observable seizures (generalized or partial-onset [simple partial motor, complex partial, or secondarily generalized] seizures) in 4 weeks during the Baseline Period, with no 3-week seizure-free period during the Baseline Period OR absence seizures documented on Screening EEG
    5) Continuing to have seizures despite a prior or current use of at least 1 AED
    6) Allowed to be on up to 3 concomitant AEDs that must have been stable in dose at least 2 weeks prior to the beginning of screening and anticipated to remain stable in dose through the end of the 8-week, placebo-controlled Treatment Period
    7) Not on, or not fully compliant with a prescribed diet plan (e.g. ketogenic diet) comprised of at least 60% total daily caloric intake from fat during previous 14 days (confirmed by 3-day diet diary at Screening), or at any time during the course of the trial
    8) Plasma level of beta-hydroxybutyrate (BHB) ? 1 mmol/L (non-fasting) at Screening
    9) Provide written or verbal assent (if possible) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures
    10) Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, comply with accurate completion of the seizures diary, and likely to complete the 8 week, placebo-controlled, Treatment Period
    11) Females of childbearing potential must have a negative pregnancy test at Screening, be willing to use an acceptable method of contraception, and have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have not reached menarche, had total hysterectomy, have been in menopause for at least two years, or have had tubal ligation at least one year prior to Screening
    1) Diagnóstico de Glut1 DS confirmado por una mutación en el SLC2A1
    2) Hombres y mujeres de entre 1 y 35 años (inclusive) al momento de firmar el consentimiento informado
    3) Un promedio de 2 crisis convulsivas observables (generalizadas o de inicio parcial) [crisis convulsivas parciales simples motoras, parciales complejas, de ausencia o generalizadas secundarias] en 4 semanas durante las últimas 24 semanas, determinadas por informe del sujeto o cuidador
    4) Por lo menos 2 crisis convulsivas observables (generalizadas o de inicio parcial) [crisis
    convulsivas parciales simples motoras, parciales complejas o generalizadas secundarias] en
    4 semanas durante el Período de Referencia, sin un período de 3 semanas sin convulsiones
    durante el Período de Referencia NI crisis de ausencia documentadas en el EEG
    5) Seguir teniendo crisis convulsivas a pesar del uso actual o pasado de por lo menos 1 AED
    6) Tiene permitido tomar hasta 3 AED concomitantes, que deben haber tenido una dosis estable
    por lo menos 2 semanas antes del comienzo de la selección y que se espera sigan teniendo
    una dosis estable hasta el final del Período de Tratamiento controlado con un placebo de 8
    7) No debe haber estado realizando, o haber cumplido totalmente, un plan de dieta recetado (por
    ejemplo, KD) compuesto por al menos un 60% de la ingesta calórica diaria de grasas
    durante los 14 días interiores (confirmado por un diario de dieta de 3 días durante la Selección), ni en ningún momento durante el curso del ensayo
    8) Nivel plasmático de beta hidroxibutirato (BHB) ? 1 mmol/L (sin estar en ayunas) en la
    9) Provisión de consentimiento escrito o verbal (de ser posible) y consentimiento informado
    escrito por parte de un representante legalmente autorizado después de que se haya
    explicado la naturaleza del estudio, y antes de cualquier procedimiento relacionado con la
    10) Debe, en la opinión del investigador, estar dispuesto a completar todos los aspectos del
    estudio, completar de manera precisa el diario de crisis convulsivas, y tener probabilidad de
    completar el Período de Tratamiento de 8 semanas controlado con un placebo, y pode
    11) Las mujeres en edad reproductiva deben realizar una prueba de embarazo y obtener un
    resultado negativo durante la Selección, estar dispuestas a utilizar un método anticonceptivo
    aceptable, y realizarse pruebas de embarazo adicionales durante el estudio. Las mujeres que
    no se considera tienen potencial reproductivo incluyen aquellas que no han tenido la
    menarca, que se realizaron una histerectomía total, que han estado en la menopausia durante
    por lo menos dos años, o que se hicieron una ligadura de trompas por lo menos un año antes
    de la Selección.
    E.4Principal exclusion criteria
    1) Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 2X the upper limit of normal at Screening
    2) Any known hypersensitivity to triheptanoin or safflower oil that, in the judgment of the investigator, places the subject at increased risk for adverse effects
    3) Prior use of triheptanoin within 30 days prior to Screening
    4) History of, or current suicidal ideation, behavior and/or attempts
    5) Pregnant and/or breastfeeding an infant at Screening
    6) Participants unwilling or unable to discontinue use of a prohibited medication or other substance that may confound study objectives
    7) Use of any investigational product (drug or supplement, including medium chain triglyceride [MCT] oil) within 30 days prior to Screening, or at any time during the study
    8) Has a condition of such severity and acuity, in the opinion of the investigator, that it warrants immediate surgical intervention or other treatment
    9) Has a concurrent disease or condition, or laboratory abnormality that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or introduces additional safety concerns (e.g., diabetes mellitus, other concurrent neurological or psychiatric disorders)
    1) Concentraciones séricas de alanina aminotransferasa (ALT) o aspartato aminotransferasa
    (AST) que superan el doble del límite superior del nivel normal en la Selección
    2) Cualquier hipersensibilidad conocida a la triheptanoína o al aceite de alazor que, a juicio del
    investigador, ponga al sujeto en mayor riesgo de sufrir efectos adversos
    3) Uso anterior de triheptanoína en los 30 días anteriores a la Selección
    4) Antecedentes de pensamientos, comportamientos o intentos suicidas, o pensamientos,
    comportamientos o intentos suicidas actuales
    5) Embarazada y/o amamantando a un bebé al momento de la Selección
    6) Participantes que no estén dispuestos a discontinuar o no puedan discontinuar el uso de un
    medicamento prohibido u otra sustancia que podría confundir los objetivos del estudio
    7) El uso de cualquier producto en investigación (fármaco o suplemento, incluyendo aceites
    triglicéridos de cadena media [MCT, por sus siglas en inglés]) en los 30 días anteriores a la
    Selección, o en cualquier momento durante el estudio
    8) Tiene una enfermedad tan grave y aguda, en la opinión del investigador, que necesita
    intervención quirúrgica inmediata u otro tratamiento
    9) Tiene una enfermedad concurrente, o anormalidad de laboratorio que, en la opinión del
    investigador, pone al sujeto en alto riesgo de muy mal cumplimiento con el tratamiento o de
    no completar el estudio, o que interferiría con la participación en el estudio o introduce
    preocupaciones de seguridad adicionales (por ejemplo, diabetes melitus, otros trastornos
    neurológicos o psiquiátricos concurrentes)
    E.5 End points
    E.5.1Primary end point(s)
    ? Seizure frequency: The number of observable seizures recorded via patient-reported diary between Weeks 2 and 8 of treatment. Observable seizures include: Generalized Tonic-Clonic, Generalized Tonic, Generalized Clonic, Generalized Atonic, Partial/Focal with Secondary Generalization, Myoclonic, Myoclonic Atonic, Myoclonic Tonic, Complex Partial/Focal, and Simple Partial/Focal Motor. The frequency of each seizure type will be recorded.

    ? Seizure frequency: The number of absence seizures recorded via EEG in those subjects who enrolled secondary solely to a history of absence seizures confirmed on Screening EEG.
    véase en el resumen del protocolo en castellano
    E.5.1.1Timepoint(s) of evaluation of this end point
    ? Observable seizures: Between Weeks 2 and 8
    ? Absence seizures: Weeks 0, 8, 26, and 31
    véase en el resumen del protocolo en castellano
    E.5.2Secondary end point(s)
    ? Seizure response rate, defined as the percentage of subjects with at least 50% reduction from Baseline Period in generalized or partial-onset seizures or absence seizures between Weeks 2 and 8 of treatment via the patient reported diary
    ? Seizure response rate, defined as the percentage of subjects with at least 50% reduction in absence seizures between Baseline EEG and Week 8 EEG.
    ? Frequency of generalized or partial-onset seizures via patient reported diary
    ? Frequency of absence seizure (recorded via EEG)
    ? Cambridge Neuropsychological Test Automated Battery: Neuropsychological function measured using a standardized, computerized battery of tests designed to assess visual memory, working memory, new learning and reaction time
    ? Six Minute Walk Test: Walking ability measured by the total distance walked (meters) in a 6-minute period. The percent of predicted normal distance walked will be determined.
    ? Paroxysmal Exertional Dyskinesia: Time to onset of PED as observed during the 6MWT
    ? Gross Motor Function Measure-88: Gross motor function evaluated using a standardized observational measure of abilities in the following 5 domains: lying/rolling, sitting, crawling/kneeling, standing, and walking/running/jumping
    véase en el resumen del protocolo en castellano
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Observable seizures: Between Weeks 2 and 8
    ? Absence seizures: Weeks 0, 8, 26, and 31
    ? Cognitive and Motor Evaluations: Timepoints upto 52 weeks
    véase en el resumen del protocolo en castellano
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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. 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 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. trial design description
    periodo de extensión de etiqueta abierta tras las 8 semanas de doble ciego
    open-label Extension Period after the initial 8-week double-blind
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    United Kingdom
    United States
    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 patient last visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 30
    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. of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    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 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. of subjects incapable of giving consent
    Paediatric subjects
    Sujetos pediátricos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 40
    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)
    After the initial 8-week double-blind Treatment Period, the open-label Extension Period will begin, wherein all subjects will be treated with UX007 through Week 52 of the study. Beyond this period, subjects may be eligible for an extension study, if warranted, through a separate protocol.
    Tras el periodo inicial de tratamiento doble ciego empezará la fase abierta de extensión en la que los sujetos serán tratados con UX007 hasta la semana 52 del estudio. Más allá de este periodo, los sujetos podrían ser candidatos an un estudio de extension, si fuera el caso, a través de un protocolo nuevo
    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 Decision2015-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-07
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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