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    Summary
    EudraCT Number:2020-000376-38
    Sponsor's Protocol Code Number:MT-1186-A03
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-000376-38
    A.3Full title of the trial
    A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)
    Étude de phase III multicentrique, en ouvert, de prolongation sur la sécurité de l’édaravone administré par voie orale pendant 96 semaines chez des patients atteints de sclérose latérale amyotrophique (SLA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)
    Une étude d'extension de la sécurité de l'édaravone par voie orale chez des sujets atteints de sclérose latérale amyotrophique (SLA)
    A.4.1Sponsor's protocol code numberMT-1186-A03
    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 SponsorMitsubishi Tanabe Pharma Development America, 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 supportMitsubishi Tanabe Pharma Development America, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMitsubishi Tanabe Pharma Development America, Inc.
    B.5.2Functional name of contact pointDaniel Selness
    B.5.3 Address:
    B.5.3.1Street Address525 Washington Boulevard, Suite 400
    B.5.3.2Town/ cityJersey City
    B.5.3.3Post codeNJ 07310
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1414704 8829
    B.5.6E-maildaniel_selness@mt-pharma-us.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 nameEdaravone
    D.3.2Product code MT-1186
    D.3.4Pharmaceutical form Oral suspension
    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 INNEDARAVONE
    D.3.9.1CAS number 89-25-8
    D.3.9.2Current sponsor codeMT-1186
    D.3.9.4EV Substance CodeSUB06453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number21
    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)
    Sclérose latérale amyotrophique (SLA)
    E.1.1.1Medical condition in easily understood language
    A disease that affects nerve cells in the brain and the spinal cord.
    Maladie qui affecte les cellules nerveuses du cerveau et de la moelle
    épinière.
    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 21.1
    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
    To evaluate the long-term safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period for 96 weeks of treatment or until the drug is commercially available in that country.
    • Évaluer l’innocuité à long terme de l’édaravone administré par voie orale à la dose de 105 mg, une fois par jour, pendant 10 jours sur une période de 14 jours, suivie par une période de 14 jours sans administration du médicament à l'étude, pendant un total de 96 semaines ou jusqu’à ce que le médicament soit mis sur le marché dans ce pays.
    E.2.2Secondary objectives of the trial
    Not applicable.
    Non applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgement of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
    2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
    3. Subjects who successfully completed Study MT-1186-A01.
    1. Les patients doivent fournir un formulaire de consentement éclairé (FCE) signé et daté pour participer à l’étude. De l'avis de l'investigateur, les patients doivent être en mesure de comprendre la nature de l’étude et tous les risques inhérents à la participation à l’étude.
    2. Les patients doivent accepter de coopérer et de suivre les restrictions et exigences du protocole.
    3. Les patients ont terminé l’étude MT-1186-A01 avec succès.
    E.4Principal exclusion criteria
    1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication. Refer to Appendix 2 of the Protocol for additional contraceptive information.
    2. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.
    3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
    4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
    1. Les patients en mesure d'avoir des enfants qui n’acceptent pas d’utiliser une méthode de contraception hautement efficace de la visite 1 jusqu’à 3 mois après la dernière administration du médicament de l’étude. Consulter l’Annexe 2 pour des informations supplémentaires relatives à la contraception.
    2. Les patients qui présentent un risque suicidaire significatif. Les patients qui présentent un comportement suicidaire ou une idéation suicidaire de type 4 (idéation suicidaire active avec intention de passer à l’acte sans plan spécifique) ou de type 5 (idéation suicidaire active avec plan et intention spécifiques) d’après l’échelle C-SSRS à la visite 1.
    3. Les patients qui ne sont pas admissibles à poursuivre l’étude, de l'avis de l’investigateur.
    4. Les patients qui ne sont pas en mesure de prendre les médicaments par voie orale ou par sonde de gastrostomie posée par voie
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoints are to evaluate the safety and tolerability of oral edaravone and include the following safety assessments:
    - Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events ([TEAEs] eg, grade, incidence and severity);
    - Physical examination;
    - Body weight;
    - 12-lead electrocardiogram (ECG) parameters;
    - Vital signs (heart rate, systolic and diastolic blood pressure, and axillary, oral, or tympanic body temperature);
    - Laboratory safety assessments (eg, hematology, chemistry, and urinalysis);
    - Columbia–Suicide Severity Rating Scale (C-SSRS)
    Critères d’évaluation principaux de l’innocuité
    Les critères d’évaluation principaux de l’innocuité ont pour but d’évaluer l’innocuité et la tolérance de l’édaravone administré par voie orale ; ils incluent les évaluations de l’innocuité suivantes :
    • Événements indésirables (EI), événements indésirables médicamenteux (EIM) et événements indésirables survenant sous traitement (EIST) (p. ex., grade, incidence et sévérité) ;
    • Examen clinique ;
    • Poids corporel ;
    • Paramètres de l’électrocardiogramme (ECG) à 12 dérivations ;
    • Constantes vitales (fréquence cardiaque, fréquence respiratoire, pression artérielle systolique et diastolique, température corporelle axillaire, buccale ou tympanique [la même méthode doit être utilisée tout au long de l’étude]) ;
    • Évaluations biologiques de l’innocuité (p. ex., hématologie, biochimie et analyse d’urine) ;
    • Échelle d’évaluation de la sévérité du risque de suicide de Columbia (Columbia-Suicide Severity Rating Scale [C-SSRS]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1-9
    Visit 1, 2, 3, 5, 7, 9
    Visit 1, 2, 3, 5, 7, 9
    Visit 1, 5, 9
    Visit 1, 2, 3, 5, 7, 9
    Visit 1, 3, 5, 7, 9
    Visit 1, 3, 5, 7, 9
    Visite 1-9
    Visite 1, 2, 3, 5, 7, 9
    Visite 1, 2, 3, 5, 7, 9
    Visite 1, 5, 9
    Visite 1, 2, 3, 5, 7, 9
    Visite 1, 3, 5, 7, 9
    Visite 1, 3, 5, 7, 9
    E.5.2Secondary end point(s)
    Not applicable.
    Non Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Non Applicable
    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 Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Canada
    France
    Germany
    Italy
    Japan
    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
    LVLS
    Dernière visite du dernier patient
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 50
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Male subjects with partners of child-bearing potential using contraception
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 100
    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)
    none
    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 Decision2021-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-09
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