Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-002348-33
    Sponsor's Protocol Code Number:A35-011
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-12-02
    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 number2022-002348-33
    A.3Full title of the trial
    A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX)
    Etude d’extension de phase IIIb menée en ouvert visant à évaluer la sécurité et la tolérance de l’AMX0035 jusqu’à 108 semaines chez des patients adultes atteints de sclérose latérale amyotrophique (SLA)précédemment inclus dans l’étude A35-004 (PHOENIX)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004
    Etude d’extension de phase IIIb menée en ouvert visant à évaluer la sécurité et la tolérance de l’AMX0035 jusqu’à 108 semaines chez des patients adultes atteints de sclérose latérale amyotrophique (SLA)précédemment inclus dans l’étude A35-004
    A.3.2Name or abbreviated title of the trial where available
    OLE Phoenix
    A.4.1Sponsor's protocol code numberA35-011
    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 SponsorAmylyx 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 supportAmylyx Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJulius Clinical
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressBroederplein 41-43
    B.5.3.2Town/ cityZeist
    B.5.3.3Post code3703 CD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31306569900
    B.5.6E-mailregulatory@juliusclinical.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/3/20/2284
    D.3 Description of the IMP
    D.3.2Product code AMX0035
    D.3.4Pharmaceutical form Oral powder
    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 INNPHENYLBUTYRATE
    D.3.9.1CAS number 1716-12-7
    D.3.9.3Other descriptive namePHENYLBUTYRATE
    D.3.9.4EV Substance CodeSUB127264
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUrsodoxicoltaurine
    D.3.9.1CAS number 14605-22-2
    D.3.9.3Other descriptive nametaurursodiol
    D.3.9.4EV Substance CodeSUB218624
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    ALS (amyotrophic lateral sclerosis)
    E.1.1.1Medical condition in easily understood language
    ALS
    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 assess the long-term safety and tolerability of treatment with AMX0035
    Évaluer à long terme la sécurité et la tolérance du traitement par l’AMX0035
    E.2.2Secondary objectives of the trial
    To assess the impact of long-term treatment with AMX0035 on survival

    Exploratory: To assess the impact of long-term treatment with AMX0035 on measures of ALS function and key events in disease progression
    Évaluer l’impact du traitement à long terme par l’AMX0035 sur la survie

    Exploratoires: Évaluer à long terme l’impact du traitement à l’AMX0035 sur des mesures fonctionnelles de la SLA et sur les événements clés de l’évolution de la maladie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previous participation in Study A35-004 (PHOENIX), including completion of the randomized-controlled phase through Week 48 (this timepoint may be upcoming at the time of screening). Participants who do not complete randomized-controlled phase through Week 48 for medical reasons may be included on a case-by-case basis, in consultation with the sponsor;
    2. Capable of providing informed consent;
    3. Capable and willing to follow trial procedures including visits to the trial clinic, remote visits, and survival status reporting requirements;
    4. Women of childbearing potential (WOCBP; e.g., not post-menopausal for at least one year or surgically sterilea must agree to use adequate birth control for the duration of the trial and 3 months after the last dose of AMX0035;
    a. 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
    b. Acceptable contraception methods for use in this trial are:
    - Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants;
    - Barier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm);
    - Intrauterine device (IUD);
    - Abstinence (no heterosexual sex);
    - Unique partner who is surgically sterile (men) or not of childbearing potential (female).
    5. Women must not be pregnant or planning to become pregnant for the duration of the trial and 3 months after last dose of AMX0035;
    6. Men must agree to practice contraception for the duration of the trial and for at least 3 months after last dose of AMX0035;
    7. Men must not plan to father a child or to provide sperm for donation for the duration of the trial and 3 months after the last dose of AMX0035;
    1. Avoir participé précédemment à l’Étude A35-004 (PHOENIX), y compris avoir complété la phase randomisée et contrôlée jusqu’à la semaine 48 (ou la compléter peu après le moment de la sélection).
    Les participants qui ne complètent pas la phase randomisée et contrôlée jusqu’à la semaine 48 pour des raisons médicales peuvent être inclus au cas par cas, après consultation avec le Promoteur ;
    2. Être capable de donner un consentement éclairé
    3. Être capable et désireux de suivre les procédures de l’essai, y compris les visites à la clinique de l’essai, les visites en distanciel et les exigences liées au rapportage de la survie ;
    4. Les femmes en âge de procréer (WOCBP ; p. ex. non ménopausées depuis au moins un an ou ayant subi une intervention chirurgicale de stérilisation) doivent accepter d’utiliser une méthode de contraception adéquate pendant toute la durée de l’essai et 3 mois après la dernière dose d’AMX0035 ;
    a. 12 mois d’aménorrhée spontanée ou 6 mois d’aménorrhée spontanée avec des taux sériques de FSH >40 mUI/ml ou 6 semaines après une ovariectomie bilatérale chirurgicale avec ou sans hystérectomie.
    b. Les méthodes de contraception acceptables dans le cadre de cet essai sont les suivantes :
    - Méthodes hormonales, telles que les pilules contraceptives, les patchs, les injections, l’anneau vaginal ou les implants ;
    - Méthodes barrières (telles qu’un préservatif ou un diaphragme) utilisées avec un spermicide (une mousse, une crème ou un gel qui tue les spermatozoïdes) ;
    - Dispositif intra-utérin (DIU) ;
    - Abstinence (pas de rapports hétérosexuels) ;
    - Partenaire unique ayant subi une intervention chirurgicale de stérilisation (hommes) ou qui n’est pas en âge de procréer (femmes).
    5. Les femmes ne doivent pas être enceintes ou prévoir de le devenir pendant la durée de l’essai et 3 mois après la dernière dose d’AMX0035 ;
    6. Les hommes doivent accepter de pratiquer la contraception pendant toute la durée de l’essai et pendant au moins 3 mois après la dernière dose d’AMX0035 ;
    7. Les hommes ne doivent pas prévoir d’engendrer un enfant ou de fournir du sperme pour un don pendant la durée de l’essai et 3 mois après la dernière dose d’AMX0035 ;
    E.4Principal exclusion criteria
    1. History of known allergy to phenyl butyrate or bile salts;
    2. Abnormal liver function defined as bilirubin levels and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 5 times the upper limit of the normal (obtained within 12 weeks from first dose);
    3. Renal insufficiency as defined by eGFR <60 mL/min/1.73m2 normal (obtained within 12 weeks from first dose);
    4. Pregnant women or women currently breastfeeding;
    5. Current severe biliary disease which may result in the Investigator medical judgement in biliary obstruction including for example active cholecystitis, primary biliary cirrhosis, sclerosing cholangitis, gallbladder cancer, gangrene of the gallbladder, abscess of the gallbladder;
    6. History of Class III/IV heart failure (per New York Heart Association – NYHA);
    7. Participant under severe salt restriction where the added salt intake due to treatment would put the participant at risk, in the Investigator clinical judgment;
    8. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, according to Investigator judgment;
    9. Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, severe laboratory test anomaly or clinically significant electrocardiogram [ECG] changes) that would pose a risk to the participant if he/she were to participate in the trial, according to Investigator judgment;
    10. Currently enrolled in another trial (excluding Study A35-004 (PHOENIX)) involving use of an investigational therapy (or within 5 plasma half-lives) prior to first dose at Baseline Visit;
    11. Implantation of Diaphragm Pacing System (DPS);
    12. Currently or previously treated within the last 30 days (or 5 half-lives, whichever is longer) from first dose at the Baseline Visit or planned exposure during the treatment period to any prohibited medications listed in Section 6.7 of the protocol.
    1. Antécédents d’allergie, hypersensibilité connue au butyrate de phényle ou aux sels biliaires, taurursodiol ou à l’un des excipients ;
    2. Fonction hépatique anormale définie par des taux d’asparate aminotransferase (AST) et/ou alanine aminotransferase (ALT) > 5 fois la limite supérieure de la normale (LSN) (obtained within 12 weeks from first dose)
    3. Insuffisance rénale définie par un DFGe <60 ml/min/1,73 m2 normal (obtenu dans les 12 semaines suivant la première dose) ;
    4. Femmes enceintes ou femmes qui allaitent ;
    5. Maladie biliaire grave actuelle pouvant entraîner, selon le jugement médical de l’Investigateur, une obstruction biliaire, y compris par exemple une cholécystite active, une cirrhose biliaire primaire, une cholangite sclérosante, un cancer de la vésicule biliaire, une gangrène de la vésicule biliaire, un abcès de la vésicule biliaire
    6. Antécédents d’insuffisance cardiaque de classe III/IV (selon la New York Heart Association – NYHA) ;
    7. Participant soumis à une restriction sévère en sel, notamment en cas d’insuffisance cardiaque congestive ou d’autres affections associées à une rétention de sodium avec œdème, où l’apport supplémentaire en sel dû au traitement mettrait le participant en danger, selon le jugement de l’Investigateur ;
    8. Présence d’une maladie psychiatrique instable, d’une déficience cognitive, d’une démence ou d’une toxicomanie qui altérerait la capacité du participant à fournir un consentement éclairé, selon le jugement de l’Investigateur ;
    9. État médical instable cliniquement significatif (autre que la SLA) (par exemple, instabilité cardiovasculaire, infection systémique, dysfonctionnement thyroïdien non traité, anomalie grave des tests de laboratoire ou modifications cliniquement significatives de l'électrocardiogramme [ECG]) qui présenterait un risque pour le participant s'il devait participer à l'essai, selon le jugement de l'investigateur;
    10. Participation actuelle à un autre essai (excepté l’Étude A35-004 (PHOENIX)) faisant usage d’un traitement expérimental (or participation terminée depuis moins de 5 demi-vies plasmatiques) au moment de la première dose lors de la visite de référence ;
    11. Implantation d’un système de stimulation du diaphragme (DPS ) ;
    12. Traitement actuel ou antérieur au cours des 30 derniers jours (ou 5 demi-vies, la période la plus longue prime), à partir de la première dose lors de la visite de référence ou bien exposition prévue pendant la période de traitement, à tout médicament interdit énuméré à la section 6.7 du protocole.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the impact of long-term treatment with AMX0035 on measures of ALS function and key events in disease progression
    Évaluer l'impact du traitement à long terme par l'AMX0035 sur les mesures de la fonction de la SLA et les événements clés de la progression de la maladie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 108 weeks of treatment and Follow-Up visit (28 days after end of treatment)
    Après 108 semaines de traitement et visite de suivie (28 jours après la fin du traitement)
    E.5.2Secondary end point(s)
    1. Overall survival of all-cause mortality

    2. Ventilation free survival (defined as death, tracheostomy for respiratory distress or permanent non-invasive ventilation [>22 hours per day for 7 consecutive days])

    Exploratory:
    Change from baseline in ALSFRS-R score at Week 108
    2. To assess the incidence rate of the following significant ALS life-events over 108 weeks:
    a) Tracheostomy for assisted ventilation;
    b) Tracheostomy for management of secretions;
    c) Permanent Assisted Ventilation (PAV) [defined as >22 hours daily of mechanical ventilation for more than one week (7 days)]. The date of onset of PAV is the first day of the 7 days;
    d) Placement of feeding tube and clinically significant (i.e., requiring hospitalization or emergency department [ED] visit) complication/intervention (e.g., displacement, replacement, complications requiring surgical intervention);
    e) Placement of infusion port (in the subset of participants receiving concurrent IV edaravone) and clinically significant (i.e., requiring hospitalization or ED visit) complication/intervention (e.g., thrombosis, bleeding, infection, replacement);
    f) Incidence and duration of hospitalizations lasting more than 24 hours.
    1. Survie globale de la mortalité toutes causes confondues

    2. Survie sans ventilation (définie comme le décès, la trachéotomie pour détresse respiratoire ou la ventilation non invasive permanente [>22 heures par jour pendant 7 jours consécutifs]).

    Exploratoires :
    Changement par rapport à la ligne de base du score ALSFRS-R à la Semaine 108
    2. Évaluer le taux d'incidence des événements significatifs suivants liés à la SLA sur une période de 108 semaines :
    a) Trachéotomie pour ventilation assistée ;
    b) Trachéotomie pour gestion des sécrétions ;
    c) Ventilation assistée permanente (VAP) [définie comme une ventilation mécanique de plus de 22 heures par jour pendant plus d'une semaine (7 jours)]. La date de début de la PAV est le premier jour de la période de 7 jours ;
    d) Mise en place d'une sonde d'alimentation et complication/intervention cliniquement significative (c'est-à-dire nécessitant une hospitalisation ou une visite au service des urgences) (par exemple, déplacement, remplacement, complications nécessitant une intervention chirurgicale) ;
    e) Mise en place du port de perfusion (dans le sous-groupe de participants recevant simultanément de l'edaravone par voie IV) et complication/intervention cliniquement significative (c'est-à-dire nécessitant une hospitalisation ou une visite aux urgences) (par exemple, thrombose, saignement, infection, remplacement) ;
    f) Incidence et durée des hospitalisations de plus de 24 heures.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 108 weeks of treatment and FU visit (28 days after end of treatment)
    Après 108 semaines de traitement et visite de suivie (28 jours après la fin du traitement)
    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 Yes
    E.8.1.7.1Other trial design description
    OLE
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    France
    Poland
    Sweden
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    Ireland
    Portugal
    United Kingdom
    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
    The end of the trial will correspond to the last participant last EOT visit/phone contact per the trial schedule. Patients will be followed for their long-term survival status.
    La fin de l'essai correspondra à la dernière visite/au dernier contact téléphonique du participant selon le calendrier de l'essai. Les patients seront suivis pour leur statut de survie à long terme.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 575
    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)
    Post trial, AMX0035 will be made available to participants completing the study period in accordance with each competent authority's regulatory guidance.
    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 Decision2023-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 05 03:23:17 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA