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    The EU Clinical Trials Register currently displays   39194   clinical trials with a EudraCT protocol, of which   6422   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-005160-41
    Sponsor's Protocol Code Number:ALK8700-A301
    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:2016-04-20
    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 number2015-005160-41
    A.3Full title of the trial
    A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis
    Estudio de fase III, abierto, para evaluar la seguridad y la tolerabilidad a largo plazo de ALKS 8700 en adultos con esclerosis múltiple remitente recurrente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    an Open Label Study of ALKS 8700 in Adults with Multiple Sclerosis
    Un estudio abierto de ALKS 8700 en adultos con esclerosis m
    A.4.1Sponsor's protocol code numberALK8700-A301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02634307
    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 SponsorAlkermes, 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 supportAlkermes, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlkermes, Inc.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address852 Winter Street
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.6E-mailjennifer.callahan@alkermes.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 nameN/A
    D.3.2Product code ALKS 8700 Delayed Release (DR) Capsule
    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 INNNot available
    D.3.9.1CAS number Not availabl
    D.3.9.2Current sponsor codeRDC-5108-00, ALKS 8700
    D.3.9.3Other descriptive nameALKS 8700
    D.3.9.4EV Substance CodeSUB179841
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number231
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Remitting Multiple Sclerosis
    Esclerosis múltiple remitente recurrente
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Esclerosis múltiple
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    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
    1) to evaluate the long-term safety and tolerability of ALKS 8700 for up to 96 weeks of treatment in adult subjects with RRMS
    1) evaluar la seguridad y la tolerabilidad a largo plazo de ALKS 8700 durante un máximo de 96 semanas de tratamiento en sujetos adultos con EMRR
    E.2.2Secondary objectives of the trial
    2) to evaluate treatment effect over time in adult subjects with RRMS treated with ALKS 8700.
    2) evaluar el efecto del tratamiento en el tiempo en sujetos adultos con EMRR tratados con ALKS 8700.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Has a confirmed diagnosis of RRMS
    - Neurologically stable with no evidence of relapse within 30 days prior
    to Visit 2
    - Additional criteria may apply
    - Diagnóstico confirmado de EMRR
    - Neurológicamente estables, sin pruebas de recidiva en los 30 días previos a la Visita 2
    - Pueden aplicar criterios adicionales
    E.4Principal exclusion criteria
    - Subject is pregnant or breastfeeding or plans to become pregnant or
    begin breastfeeding at any point during the study and for 30 days after
    any study drug administration
    - Diagnosis of primary progressive secondary progressive, or progressive
    relapsing MS
    - History of clinically significant cardiovascular, pulmonary,
    gastrointestinal (inflammatory bowel disease [IBD]; Crohn's disease,
    ulcerative colitis), dermatologic, psychiatric, neurologic (other than MS),
    and/or other major disease that would preclude participation in a clinical
    trial
    - History of a myocardial infarction, including a silent myocardial
    infarction identified on ECG, or unstable angina
    - Additional criteria may apply
    - La sujeto está embarazada o en período de lactancia o planea quedarse embarazada o comenzar la lactancia en cualquier momento durante el estudio y durante 30 días después de la administración de cualquier fármaco del estudio.
    - Diagnóstico de EM primaria progresiva, secundaria progresiva o recurrente progresiva
    - Antecedentes de enfermedad cardiovascular, pulmonar, gastrointestinal (enfermedad inflamatoria intestinal [EII]; enfermedad de Crohn, colitis ulcerosa), dermatológica, psiquiátrica, neurológica (que no sea EM) y/u otras graves que impedirían la participación en un ensayo clínico
    - Antecedentes de infarto de miocardio, como infarto de miocardio silente identificado en el ECG o angina inestable
    - Pueden aplicar criterios adicionales
    E.5 End points
    E.5.1Primary end point(s)
    - Safety will be demonstrated by incidence of Adverse Events
    - All enrolled subjects who receive at least one dose of ALKS 8700 will be
    used in the safety and tolerability analysis
    - La seguridad se demonstrará por la incidencia de Acontecimientos Adversos
    - Se emplearán para el análisis de seguridad y tolerabilidad todos los sujetos que hayan recibido al menos una dosis de ALKS 8700
    E.5.1.1Timepoint(s) of evaluation of this end point
    various study visits
    varias visitas del estudio
    E.5.2Secondary end point(s)
    N/A
    Otros criterios de valoración
    ?SF-12 (puntuación del dominio)
    ?Puntuaciones en la escala analógica visual EQ-5D-5L
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    varias visitas 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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Belgium
    Bulgaria
    Canada
    Germany
    Poland
    Russian Federation
    Serbia
    Spain
    Ukraine
    United States
    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
    LPLV
    Última visita del último paciente
    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 months1
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days4
    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: 501
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 600
    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 that condition
    tratamiento normal para esa enfermedad
    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 Decision2016-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
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