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    Summary
    EudraCT Number:2017-004580-12
    Sponsor's Protocol Code Number:IISS-57325
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-004580-12
    A.3Full title of the trial
    Treatment of Restless Legs Syndrome with the Hypocretin Antagonist Suvorexant
    Tratamiento del Síndrome de Piernas Inquietas con el antagonista de las hipocretinas suvorexant: Un estudio piloto”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Restless Legs Syndrome with the Hypocretin Antagonist Suvorexant
    Tratamiento del Síndrome de Piernas Inquietas con el antagonista de las hipocretinas suvorexant: Un estudio piloto”
    A.4.1Sponsor's protocol code numberIISS-57325
    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 SponsorInstituto de investigación del sueño
    B.1.3.4CountrySpain
    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 supportInstituto de investigación del sueño
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de investigación del sueño
    B.5.2Functional name of contact pointDiego García-Borreguero
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Habana, 151
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code20836
    B.5.3.4CountrySpain
    B.5.4Telephone number0034913454129
    B.5.6E-maildgb@iis.es
    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 Yes
    D.2.1.1.1Trade name Belsomra
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, Sharp & Dohme, Corp., subsidiary of Merck & Co, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameBelsomra 10/20 mg
    D.3.4Pharmaceutical form Tablet
    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 INNSUVOREXANT
    D.3.9.1CAS number 1030377-33-3
    D.3.9.4EV Substance CodeSUB180101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboTablet
    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
    Treatment of Restless Legs Syndrome with the Hypocretin Antagonist Suvorexant
    Tratamiento del Síndrome de Piernas Inquietas con el antagonista de las hipocretinas suvorexant
    E.1.1.1Medical condition in easily understood language
    Treatment of Restless Legs Syndrome with the Hypocretin Antagonist Suvorexant
    Tratamiento del Síndrome de Piernas Inquietas con el antagonista de las hipocretinas suvorexant
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of suvorexant on sleep in RLS/WED patients suffering on insomnia measured objectively by means
    of polysomnography.
    Investigar mediante polisomnografía los efectos terapéuticos de suvorexant sobre el sueño (en concreto, sobre las variables tiempo de vigilia intrasueño (WASO) y tiempo total de sueño (TST)) en pacientes con SPI e insomnio.
    E.2.2Secondary objectives of the trial
    To investigate potential therapeutic effects of suvorexant on sensory and motor symptoms in RLS/WED, as measured by subjective rating scales.

    To investigate potential therapeutic effects of suvorexant on sensory and motor symptoms in RLS/WED, as measuredobjectively by the multiple Suggested Immobilization Test* (mSIT).
    Investigar mediante escalas subjetivas el potencial beneficio terapéutico de suvorexant sobre los síntomas sensitivos y motores de SPI.
    I
    nvestigar mediante test de inmovilización múltiple el potencial beneficio terapéutico potencial de suvorexant sobre los síntomas sensitivos y motores de SPI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Idiopathic RLS, according to diagnostic criteria established by the International RLS Study Group (Allen et al., 2003).
    • A history (if currently controlled on medication) or the presence of RLS symptoms
    causing insomnia/ sleep disturbance on 3 or more days per week for at least 12 months.
    • An IRLS score ≥15 at baseline assessment: Absence of significant RLS symptoms
    before 9PM (measured by diary)
    • Aged 18 - 80 years.
    • PSG at screening containing:
    WASO≥ 60 minutes
    PLMAI of ≥ 15
    TST<6.6hours
    • Women of childbearing potential must have a negative pregnancy test at screen and must agree not to become pregnant.
    • Prior to any study-specific procedures, a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
    SPI idiopático
    • Historia de síntomas de SPI que causen
    insomnio/alteración del sueño en ≥ 3 días/semana,
    durante al menos los últimos 12 meses.
    Tener un índice de puntuación de la escala IRLS ≥20 en la
    evaluación basal, con ausencia de síntomas significativos
    antes de las 9PM (evaluados mediante agenda de SPI).
    • Variables de PSG en la visita basal:
    WASO≥ 60 minutos
    PLMAI ≥ 15
    TST<6.6 horas
    • 18 - 80 años.
    • Las mujeres en edad fértil deberán de tener un test de
    embarazo negativo en la visita de screening y deberán
    acceder a utilizar métodos contraceptivos médicamente
    probados.
    • Entender y firmar la hoja de consentimiento.
    E.4Principal exclusion criteria
    1. Any secondary forms of RLS.
    2. History or current diagnosis of other clinically relevant diseases that may confound assessments or RLS symptoms.
    3. Serum ferritin <18 mcg/ml
    4. If the patient is currently being treated with drugs likely to influence sleep architecture or motor manifestations during
    sleep (such as neuroleptics, L-dopa, dopamine agonists, hypnotics, sedatives, antidepressants, anxiolytics, anticonvulsants,
    psychostimulant medications, steroids, barbiturates and opiates), a wash-out period of at least > 5 half-lives will be
    undertaken.
    5. Employed in shift work (for example, employment hours disruptive to the normal circadian sleep-wake cycle such as
    nighttime or variable rotating shifts) or irregular sleep-wake schedules.
    6. Patients who require prescription medication for concurrent conditions which could interfere with efficacy assessments.
    7. Surgery within 180 days of baseline visit, which in the opinion of the investigator would negatively impact the patient’s
    participation in the study.
    8. A significant medical or psychiatric disorder.
    9. Any other clinically significant condition or laboratory assay abnormality, which would interfere with the patient’s ability
    to participate in the study.
    10. Other severe acute or chronic medical or psychiatric condition or laboratory assay abnormality that may increase the risk
    associated with study participation or study drug administration or may interfere with the interpretation of study results and
    would make the patient inappropriate for entry into this study.
    11. Breastfeeding.
    1. Cualquier forma secundaria de RLS.
    2. Historial o diagnóstico actual de otras enfermedades clínicamente relevantes que pueden confundir las evaluaciones o los síntomas del SPI.
    3. Ferritina sérica <18 mcg / ml
    4. Si el paciente actualmente está siendo tratado con medicamentos que pueden influir en la arquitectura del sueño o las manifestaciones motoras durante sueño (como neurolépticos, L-dopa, agonistas de dopamina, hipnóticos, sedantes, antidepresivos, ansiolíticos, anticonvulsivos,
    medicamentos psicoestimulantes, esteroides, barbitúricos y opiáceos), se realizará un período de lavado de al menos> 5 vidas medias.
    emprendido.
    5. Empleados en el trabajo por turnos (por ejemplo, horas de empleo que interrumpen el ciclo circadiano normal de sueño-vigilia, como horarios nocturnos o cambios rotatorios variables) o horarios irregulares de sueño y vigilia.
    6. Pacientes que requieren medicamentos recetados para afecciones concurrentes que podrían interferir con las evaluaciones de eficacia.
    7. Cirugía dentro de los 180 días posteriores a la visita inicial, que en opinión del investigador tendría un impacto negativo en el paciente participación en el estudio.
    8. Un trastorno médico o psiquiátrico significativo.
    9. Cualquier otra condición clínicamente significativa o anormalidad en el análisis de laboratorio que pueda interferir con la capacidad del paciente
    para participar en el estudio.
    10. Otra condición médica o psiquiátrica aguda o crónica grave o anomalía en el análisis de laboratorio que pueda aumentar el riesgo asociado con la participación en el estudio o la administración del fármaco del estudio o puede interferir con la interpretación de los resultados del estudio y haría al paciente inapropiado para ingresar a este estudio.
    11. Lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Comparison between both treatment conditions of:
    • Change (differences between visits 2 and 5) in WASO.
    Co-primary Endpoints
    • Change (differences between visits 2 and 5) in Total Sleep Time.
    Comparación entre ambas condiciones de tratamiento de:
    • Cambio (diferencias entre las visitas 2 y 5) en WASO.
    Puntos extremos co-primarios
    • Cambio (diferencias entre las visitas 2 y 5) en el Tiempo de suspensión total
    E.5.1.1Timepoint(s) of evaluation of this end point
    Changes between baseline and end of study visit
    Cambios entre la visita inicial y la del final del estudio
    E.5.2Secondary end point(s)
    Comparison between both treatment conditions of:
    • Change (differences between visits 2 and 5) in IRLS total score
    Change (differences between visits 2 and 5) in CGI
    • Change (differences between visits 2 and 5) in TST
    • Change (differences between visits 2 and 5) in PLMS (periodic leg movement during sleep)-index
    • Change (differences between visits 2 and 5) in PLMS with arousals (PLMW-index)
    • Change ((differences between visits 2 and 5) in multiple suggested immobilization test
    Comparación entre ambas condiciones de tratamiento de:
    • Cambio (diferencias entre las visitas 2 y 5) en el puntaje total de IRLS
    Cambio (diferencias entre las visitas 2 y 5) en CGI
    • Cambio (diferencias entre las visitas 2 y 5) en TST
    • Cambio (diferencias entre las visitas 2 y 5) en PLMS (movimiento periódico de las piernas durante el sueño) -index
    • Cambio (diferencias entre las visitas 2 y 5) en PLMS con despertares (índice PLMW)
    • Cambio ((diferencias entre las visitas 2 y 5) en múltiples pruebas de inmovilización sugeridas
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes between baseline and end of study visit
    Cambios entre la visita inicial y la del final del estudio
    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 No
    E.6.7Pharmacodynamic Yes
    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) 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    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 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
    LVSL
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 43
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state43
    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)
    N/A
    n/A
    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 Decision2018-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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