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    Summary
    EudraCT Number:2015-001521-16
    Sponsor's Protocol Code Number:1VIT14037
    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:2016-02-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-001521-16
    A.3Full title of the trial
    A Double-Blinded, Multi-Center, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) in the Treatment of Restless Legs Syndrome (RLS)
    Estudio multicéntrico, doble ciego, aleatorizado y controlado con placebo para investigar la eficacia y la seguridad de Injectafer® (carboximaltosa férrica) en el tratamiento del síndrome de piernas inquietas (SPI).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) in the Treatment of Restless Legs Syndrome (RLS).
    Un estudio para evaluar la eficacia y la seguridad Injectafer®(Ferric Carboxymaltose) en el tratamiento de pacientes con síndrome de piernas inquietas (SPI).
    A.4.1Sponsor's protocol code number1VIT14037
    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 SponsorLuitpold Pharmaceuticals, 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 supportLuitpold Pharmaceuticals, Inc. Clinical Research and Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES PLANIFICACION
    B.5.2Functional name of contact pointUnidad de Puesta en Marcha
    B.5.3 Address:
    B.5.3.1Street Addressc/ Rufino González 14, Esc. 1ª - 2º D
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913275025
    B.5.5Fax number+34917542721
    B.5.6E-mailstart-up@sermescro.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 Yes
    D.2.1.1.1Trade name Injectafer®
    D.2.1.1.2Name of the Marketing Authorisation holderLuitpold Pharmaceuticals, 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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.4EV Substance CodeSUB66620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Restless Leg Syndrome (RLS)
    Síndrome de piernas inquietas (SPI)
    E.1.1.1Medical condition in easily understood language
    Restless Leg Syndrome (RLS)
    Síndrome de piernas inquietas (SPI)
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10058920
    E.1.2Term Restless legs syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy and safety of an IV Injectafer® in subjects with Restless Leg Syndrome (RLS).
    El objetivo principal de este estudio es evaluar la eficacia y la seguridad de Injectafer® administrado por vía intravenosa en pacientes con síndrome de piernas inquietas (SPI).
    E.2.2Secondary objectives of the trial
    n/a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects ?18 years of age or older, able and willing to give informed consent to the study
    2. RLS symptoms affirming diagnosis. The IRLS Diagnostic Criteria for RLS must be met:
    a. An urge (distressing need) to move the legs usually associated with painful or uncomfortable sensations in the legs. The urge to move may be present without the uncomfortable sensations. The arms or other body parts may be involved in addition to the legs.
    b. The urge to move or unpleasant sensations are worse or exclusively present at rest or inactivity, such as lying down or sitting.
    c. The urge to move or unpleasant sensations are partially/temporarily relieved with walking or moving the legs.
    d. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. When symptoms are severe, the worsening at night may not be noticeable but must have been previously present.
    3. Subjects should be on monotherapy for RLS. Treatment should be stable for at least 8 weeks prior to screening. (See approved RLS Therapies/Regimen in Appendix III in Study Protocol )
    4. A score ? 15 on the IRLS Rating Scale at screening and on Day 0 prior to dosing.
    5. Subjects on anti-depressants and sleep medications must be on a stable dose for at least 6 months.
    6. Subject has regular sleep hours between 9 pm and 9 am.
    7. Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.
    1. Pacientes de ambos sexos > o = 18 años dispuestos y capaces de proporcionar el consentimiento informado para el estudio.
    2. Síntomas de SPI que confirmen el diagnóstico. Deberán cumplirse los criterios diagnósticos de la IRLS:
    a. Una necesidad imperiosa de mover las piernas, habitualmente asociada a sensaciones dolorosas o desagradables en las piernas. La necesidad imperiosa de moverse puede estar presente sin sensaciones desagradables. También puede afectar a los brazos u otras partes del cuerpo.
    b. La necesidad imperiosa de moverse o las sensaciones desagradables son peores o solo aparecen en reposo o inactividad, como cuando se está tumbado o sentado.
    c. La necesidad imperiosa de moverse o las sensaciones desagradables se alivian parcial o temporalmente al andar o mover las piernas.
    d. La necesidad imperiosa de moverse o las sensaciones desagradables son peores a última hora de la tarde o por la noche que durante el día o solo se producen a esas horas. Cuando los síntomas son graves, puede que el empeoramiento nocturno no resulte perceptible, pero debe haber estado presente previamente.
    3. Los pacientes deberán recibir un solo tratamiento para el SPI. El tratamiento deberá haberse mantenido estable durante al menos las 8 semanas previas a la selección (véanse los Tratamientos/pautas aprobados para el SPI en el Apéndice III).
    4. Puntuación > o = 15 en la escala de valoración IRLS en la selección y el día 0 antes de la administración.
    5. Los pacientes con antidepresivos y somníferos deberán recibir una dosis estable durante al menos 6 meses.
    6. El paciente duerme habitualmente entre las 9 p.m. y las 9 a.m.
    7. Las pacientes en edad fértil deberán tener una prueba de embarazo negativa al inicio y utilizar un método anticonceptivo aceptable: haberse sometido a histerectomía o ligadura de trompas, o de lo contrario ser estériles, o haber utilizado cualquiera de los siguientes métodos anticonceptivos durante al menos el mes previo a la inclusión en el estudio: anticonceptivos hormonales, espermicida con método de barrera, dispositivo intrauterino o esterilidad de la pareja.
    E.4Principal exclusion criteria
    1. RLS 2° to other disease or injury.
    2. Treatment of such disorders that require RLS indicators such as peripheral neuropathy and neurodegenerative disorders (i.e. Parkinson?s Disease or Dementia).
    3. Stage 4 ? 5 CKD, subjects on dialysis or anticipated to start dialysis while participating in this study.
    4. Any pain related (e.g., frequent muscle cramps, myalgia, fibromyalgia) or sleep related disorders (e.g. sleep apnea, unless on stable Continuous Positive Airway Pressure [CPAP]) which may confound the outcome measures.
    5. Subjects with Multiple Sclerosis.
    6. History of neuroleptic akathisia.
    7. Parenteral iron use within 6 weeks prior to screening.
    8. History of >10 blood transfusions in the past 2 years.
    9. Anticipated need for blood transfusion during the study.
    10. Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose).
    11. Previously randomized to Injectafer® (FCM or VIT-45) in a clinical trial.
    12. Current, active or acute or chronic infection other than viral upper respiratory tract infection.
    13. Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ? 5 years).
    14. Pregnant or lactating women.
    15. Seizure disorder currently being treated with medication.
    16. Baseline ferritin ?300 ng/mL.
    17. Baseline TSAT ?45%.
    18. History of hemochromatosis or hemosiderosis or other iron storage disorders.
    19. AST or ALT greater than 2 times the upper limit of normal.
    20. Hemoglobin greater than the upper limit of normal.
    21. Known positive hepatitis B antigen (HBsAg) unless positive test can be attributed to receipt of hepatitis B vaccination in childhood or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal).
    22. Known positive HIV-1/HIV-2 antibodies (anti-HIV)
    23. Received an investigational drug within 30 days before randomization.
    24. Chronic alcohol or drug abuse within the past 6 months.
    25. Any other pre-existing laboratory abnormality, medical condition or disease which per the investigator may put the subject at risk if they participate in the study.
    26. Subject unable or unwilling to comply with the study requirements.
    SPI secundario a otra enfermedad o lesión.
    2. Los trastornos que precisan tratamiento con la misma medicación utilizada para el SPI incluyen: neuropatía periférica y trastornos neurodegenerativos (enfermedad de Parkinson o demencia).
    3. NC en estadio 4-5, pacientes en diálisis o en los que esté previsto iniciar la diálisis durante la participación en este estudio.
    4. Cualquier trastorno relacionado con el dolor (p. ej., calambres musculares frecuentes, mialgia, fibromialgia) o el sueño (p. ej., apnea del sueño, salvo que reciba ventilación con presión positiva continua [CPAP]) que pudiera confundir los criterios de valoración.
    5. Pacientes con esclerosis múltiple.
    6. Antecedentes de acatisia en neurolépticos.
    7. Uso de hierro parenteral en las 6 semanas previas a la selección.
    8. Antecedente de > 10 transfusiones de sangre en los 2 años anteriores.
    9. Necesidad prevista de transfusión de sangre durante el estudio.
    10. Reacción de hipersensibilidad conocida a cualquier componente de Injectafer® (carboximaltosa férrica).
    11. Aleatorización previa a Injectafer® (FCM o VIT-45) en un ensayo clínico.
    12. Infección actual, activa, aguda o crónica distinta de infección vírica de las vías respiratorias altas
    13. Neoplasia maligna (distinta de carcinoma basocelular o escamoso de la piel o ausencia de cáncer durante > o = 5 años).
    14. Mujeres embarazadas o en período de lactancia.
    15. Trastorno convulsivo con tratamiento actual.
    16. Ferritina inicial > o = 300 ng/ml.
    17. TSAT inicial > o = 45 %.
    18. Antecedente de hemocromatosis, hemosiderosis u otros trastornos de almacenamiento de hierro.
    19. AST o ALT superior a 2 veces el límite superior de la normalidad (LSN).
    20. Hemoglobina superior al LSN.
    21. Antígeno de la hepatitis B (HBsAg) positivo conocido, salvo que el resultado positivo pueda atribuirse a la recepción de la vacuna frente a la hepatitis B en la infancia o anticuerpos virales frente a la hepatitis C (HCV) con signos de hepatitis activa (es decir, AST/ALT superior al límite superior de la normalidad).
    22. Anticuerpos de VIH-1/VIH-2 positivos conocidos (anti-VIH).
    23. Recepción de un fármaco en investigación en los 30 días previos a la aleatorización.
    24. Alcoholismo o drogodependencia en los 6 meses previos.
    25. Cualquier otra anomalía analítica, afección médica o enfermedad preexistentes que, según el investigador, puedan poner al paciente en riesgo si participa en el estudio.
    26. Paciente incapaz o no dispuesto a cumplir con los requisitos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy variables will be IRLS total score change from baseline to Day 42 and the proportion of patients rated as much or very much improved with the Clinical Global Impression (CGI) performed by Investigator (CGI-I) on Day 42. Baseline values used for evaluation will be defined as the latest value obtained prior to the first dose of study drug. For those subjects with only one value prior to dosing, the single value will be used as baseline.
    Las covariables de eficacia principales serán el cambio en la puntuación total de la IRLS entre el inicio y el día 42 y la proporción de pacientes con mucha o muchísima mejora en la Impresión clínica global (CGI) a cargo del investigador (CGI-I) realizada el día 42. Los valores basales para la evaluación serán definidos como los últimos valores obtenidos. Antes de la primera administración del fármaco. Para aquellos pacientes con un único valor antes de la administración del fármaco, este valor será utilizado como el basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 42
    Día 42
    E.5.2Secondary end point(s)
    The major secondary efficacy endpoints in ranked order of testing include:
    1. Clinical Global Impression (CGI) performed by Subject (CGI-S) on Day 42.
    2. Restless Legs Syndrome Quality of Life (RLS-QLI) change from baseline to Day 42.
    3. Medical Outcome Study (MOS) Sleep Scale change from baseline to Day 42.
    4. Fatigue Linear Analog Scale change from baseline to Day 42.

    Other efficacy endpoints:
    1. Proportion of responders (any improvement) based on CGI-I at each time point.
    2. IRLS total score change from baseline at each time point.
    3. Proportion of responders based on CGI-S at each time point.
    4. RLS-QLI scores change from baseline at each time point.
    5. MOS Sleep scale total score change from baseline at each time point.
    6. Fatigue Linear Analog Scale total score change from baseline at each time point.
    7. Augmentation Scale change between baseline, Day 42, Day 168 and end of study (Day 365).
    8. Proportion of subjects require intervention for RLS.
    9. Number of days from Day 5 to next dose of study drug.

    The safety endpoints include:
    1. Incidence of treatment emergent adverse events (TEAE) and incidence of serious adverse events (SAE)
    2. Change in clinical laboratory tests
    3. Change in vital signs
    4. Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
    Los principales criterios de valoración secundarios de la eficacia en orden jerárquico serán:
    1. Impresión clínica global (CGI) a cargo del paciente (CGI-S) el día 42.
    2. Cambio en el cuestionario sobre calidad de vida en el síndrome de piernas cansadas (RLS-QLI) entre el inicio y el día 42.
    3. Cambio en la escala de sueño del estudio de resultados médicos (MOS) entre el inicio y el día 42.
    4. Cambio en la escala analógica lineal de la fatiga entre el inicio y el día 42.
    Otros criterios de valoración de la eficacia:
    1. Proporción de pacientes que responden (cualquier mejora) basándose en la CGI-I en cada momento de evaluación.
    2. Cambio en la puntuación total de la IRLS entre el inicio y cada momento de evaluación.
    3. Proporción de pacientes que responden basándose en la CGI-S en cada momento de evaluación.
    4. Cambio en las puntuaciones de RLS-QLI entre el inicio y cada momento de evaluación.
    5. Cambio en la puntuación total de la escala de sueño de MOS entre el inicio y cada momento de evaluación.
    6. Cambio en la puntuación total de la escala analógica lineal de la fatiga entre el inicio y cada momento de evaluación.
    7. Cambio en la escala de aumento entre el inicio y los días 42, 168 y el final del estudio (día 365).
    8. Proporción de pacientes que requieren intervención para el SPI.
    9. Número de días desde el día 5 hasta la siguiente dosis del fármaco del estudio.
    Los criterios de valoración de la seguridad incluyen:
    1. Incidencia de acontecimientos adversos de aparición durante el tratamiento (AAAT) y acontecimientos adversos graves (AAG).
    2. Cambio en las pruebas analíticas.
    3. Cambio en las constantes vitales.
    4. Cambio en la escala de valoración de la Universidad de Columbia para la intensidad de ideas suicidas (C-SSRS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described in section E.5.2.
    Como descrito en la sección E.5.2.
    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 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) No
    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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Czech Republic
    Hungary
    Poland
    Ukraine
    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
    La 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 months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 200
    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)
    Normal treatment of the condition.
    Tratamiento clínico habitual
    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 Decision2016-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-02
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