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    The EU Clinical Trials Register currently displays   43207   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-006119-70
    Sponsor's Protocol Code Number:223AS304
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-11
    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 number2011-006119-70
    A.3Full title of the trial
    An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis
    Estudio de extensión, multicéntrico y abierto, para evaluar la seguridad y la eficacia a largo plazo de dexpramipexol (BIIB050) en sujetos con esclerosis lateral amiotrófica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)
    Estudio Clínico de Extensión de dexpramipexol en esclerosis lateral amiotrófica
    A.3.2Name or abbreviated title of the trial where available
    ENVISION
    ENVISION
    A.4.1Sponsor's protocol code number223AS304
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointALS Clinical Trials Teams
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailALSclinicaltrials@biogenidec.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/616
    D.3 Description of the IMP
    D.3.1Product nameDexpramipexole
    D.3.2Product code BIIB050/KNS-760704
    D.3.4Pharmaceutical form Film-coated 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.3.9.1CAS number 908244-04-2
    D.3.9.2Current sponsor codeBIIB050 / KNS-760704
    D.3.9.3Other descriptive nameDexpramipexole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Amyotrophic Lateral Sclerosis (ALS)
    esclerosis lateral amiotrófica
    E.1.1.1Medical condition in easily understood language
    Lou Gehrig's disease (ALS)
    esclerosis lateral amiotrófica (ELA)
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    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
    The primary objective of the study is to evaluate the long-term safety profile of dexpramipexole in subjects with ALS.
    El objetivo principal del estudio es evaluar el perfil de seguridad a largo plazo del dexpramipexol en sujetos con ELA.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the long-term efficacy of dexpramipexole in this study population using clinical endpoints measuring function and survival.
    El objetivo secundario de este estudio es evaluar la eficacia a largo plazo del dexpramipexol en esta población de estudio mediante criterios de valoración clínicos que miden la función y la supervivencia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or have the consent confirmed by a witness if unable to write) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
    2. Subject was enrolled in either Study CL211 or Study 223AS302.
    3. Subject has completed their last visit in Study CL211 or Study 223AS302.
    4. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment. For further details of contraceptive requirements for this study
    1. El sujeto es capaz de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado firmado y fechado (o hacer que un testigo confirme el consentimiento, si no es capaz de escribir) y la autorización para usar información de salud protegida (protected health information, PHI), de acuerdo con las normativas nacionales y locales sobre la privacidad de los sujetos.
    2. El sujeto estuvo inscrito en el estudio CL211 o en el estudio 223AS302.
    3. El sujeto ha completado su última visita en el estudio CL211 o en el estudio 223AS302.
    4. Los sujetos con capacidad reproductiva deben utilizar medidas anticonceptivas eficaces durante el estudio, así como estar dispuestos y ser capaces de continuar con ellas durante 1 mes (mujeres) o 3 meses (varones) después de su última dosis del tratamiento del estudio. Para obtener más detalles sobre los requisitos relativos al uso de métodos anticonceptivos para este estudio
    E.4Principal exclusion criteria
    1. Subject withdrew prematurely from Study CL211 or Study 223AS302.
    2. Subject permanently discontinued study treatment in Study CL211 or Study 223AS302 for any reason other than enrollment into this study.
    3. Subject from Study CL211 or Study 223AS302 has a significant change in medical history (including laboratory tests or a clinically significant condition) that in the opinion of the Investigator would impair the subject?s medical fitness for participation and preclude treatment.
    4. Female subject who is pregnant or breastfeeding.
    5. Subject is currently enrolled in any investigational drug study other than Study CL211 or Study 223AS302.
    6. Subject is taking pramipexole, other dopamine agonists, any other agent with dopaminergic activity, or any other disallowed concomitant medication
    7. Subject is unwilling or unable to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject?s ability to comply with the protocol. At a minimum, subjects who are not able to travel to the study site must be willing to agree to remote blood draws for clinical laboratory evaluations and telephone visits to report AEs, concomitant medications, and ALSFRS-R scores.
    1. El sujeto se retiró anticipadamente del estudio CL211 o del estudio 223AS302.
    2. El sujeto interrumpió permanentemente el tratamiento del estudio en el estudio CL211 o 223AS302 por cualquier motivo distinto a la inscripción en el presente estudio.
    3. El sujeto del estudio CL211 o 223AS302 tiene un cambio significativo en la historia clínica (incluidas pruebas de laboratorio o una enfermedad clínicamente significativa) que según la opinión del investigador impediría que el sujeto tuviera el estado médico adecuado para participar e impediría el tratamiento.
    4. Sujeto del sexo femenino que esté embarazada o en periodo de lactancia.
    5. El sujeto está inscrito en la actualidad en un estudio de algún fármaco en investigación distinto al estudio CL211 o al 223AS302.
    6. El sujeto está tomando pramipexol, otros agonistas de la dopamina, algún otro medicamento con actividad dopaminérgica o cualquier otro medicamento concomitante prohibido.
    7. El sujeto no quiere o no puede cumplir con los requisitos del protocolo, lo que incluye presencia de cualquier enfermedad (física, mental o social) que probablemente afecte la capacidad del sujeto de cumplir con el protocolo. Como mínimo, los sujetos que no puedan desplazarse hasta el centro del estudio deben estar dispuestos a someterse a extracciones de sangre a distancia para la realización de las evaluaciones de laboratorio clínico y a llevar a cabo entrevistas telefónicas para informar de los AA, de los medicamentos concomitantes y de las puntuaciones de la ALSFRS-R.
    E.5 End points
    E.5.1Primary end point(s)
    - incidence of AEs and SAEs
    - discontinuation of study treatment due to an AE
    - changes in vital signs, clinical laboratory assessments (hematology, blood chemistry, and urinalysis), 12-lead ECGs, and body weight
    - incidence of laboratory abnormalities
    - La incidencia de AA y AAG
    - La interrupción del tratamiento del estudio debido a un AA
    - Los cambios en las constantes vitales, las evaluaciones de laboratorio clínico (hematología, bioquímica sanguínea y análisis de orina), los electrocardiogramas (ECG) de 12 derivaciones y el peso corporal
    - La incidencia de anomalías de laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    As necessary
    Lo necesario
    E.5.2Secondary end point(s)
    - change in ALSFRS-R score
    - decline in SNIP
    - time to death
    - time to death or death equivalent (tracheostomy or permanent assisted ventilation [PAV], defined as use of noninvasive ventilation [NIV] for ?22 hours per day for ?10 days)
    - El cambio en la puntuación de la ALSFRS-R
    - La reducción de la SNIP
    - El tiempo hasta la muerte
    - El tiempo hasta la muerte o equivalente a la muerte (traqueotomía o ventilación asistida permanente [VAP], definida como el uso de ventilación no invasiva [VNI] durante ? 22 horas al día durante ? 10 días)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As necessary
    Lo necesario
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Australia
    Canada
    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
    The end of study is last subject, last visit.
    El fin de estudio es último paciente, última visita.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months8
    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: 739
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 111
    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 state57
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 850
    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)
    Study treatment will continue for up to 36 months or until local regulatory approval is obtained in the country and dexpramipexole is commercially available in that country (unless approval is denied or the application is withdrawn by the Sponsor), whichever comes first.
    El tratamiento del estudio continuará durante 36 meses o hasta que se obtenga la aprobación regulatoria local en el país y el dexpramipexol esté disponible en el mercado de ese país (a menos que la aprobación sea denegada o que el promotor retire la solicitud), lo que suceda primero.
    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 Decision2012-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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