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    Summary
    EudraCT Number:2019-003448-58
    Sponsor's Protocol Code Number:3101-304-002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003448-58
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants with Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)
    Studio di fase 3, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, multicentrico, teso a valutare l’efficacia, la sicurezza e la tollerabilità di atogepant per via orale per la profilassi dell’emicrania in partecipanti con emicrania episodica che in precedenza non hanno risposto a trattamenti con 2 delle 4 classi di agenti profilattici per via orale (ELEVATE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Atogepant for prophylaxis of migraine in participants who failed previous oral prophylactic treatments
    Atogepant per la profilassi dell’emicrania in partecipanti che non hanno risposto a pregressi trattamenti profilattici per via orale
    A.3.2Name or abbreviated title of the trial where available
    ELEVATE
    ELEVATE
    A.4.1Sponsor's protocol code number3101-304-002
    A.5.4Other Identifiers
    Name:INDNumber:114780
    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 SponsorALLERGAN 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 supportAllergan Sales LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street AddressMarlow International, Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailML-CTRG@Allergan.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 nameAtogepant
    D.3.2Product code [AGN-241689]
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNAtogepant
    D.3.9.1CAS number 1374248-81-3
    D.3.9.2Current sponsor codeAGN-241689
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 nameAtogepant
    D.3.2Product code [AGN-241689]
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNAtogepant
    D.3.9.1CAS number 1374248-81-3
    D.3.9.2Current sponsor codeAGN-241689
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episodic migraine
    Emicrania episodica
    E.1.1.1Medical condition in easily understood language
    Episodic migraine
    Emicrania episodica
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032066
    E.1.2Term Other forms of migraine
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To prospectively test for superiority of atogepant 30 mg QD and atogepant 60 mg QD versus placebo for the prevention of migraine in participants with episodic migraine who have previously failed 2 to 4 classes of oral medications for the prophylaxis of migraine
    Test prospettico per la superiorità di atogepant 30 mg QD e atogepant 60 mg QD rispetto al placebo per la prevenzione dell'emicrania nei partecipanti con emicrania episodica che hanno precedentemente fallito da 2 a 4 classi di farmaci orali per la profilassi dell'emicrania
    E.2.2Secondary objectives of the trial
    To evaluate the effect of atogepant 30 mg QD and atogepant 60 mg QD versus placebo for the prophylaxis of headache.

    To evaluate the effect of atogepant 30 mg QD and atogepant 60 mg QD versus placebo on acute medication use.

    To evaluate the effect of atogepant 30 mg QD and atogepant 60 mg QD versus placebo on the proportion of participants with at least 50% reduction from baseline in monthly migraine days.

    To evaluate the effect of atogepant 30 mg QD and atogepant 60 mg QD versus placebo on the impact of migraine on daily activities as assessed by MSQ v2.1 Role Function-Restrictive domain score.

    For the European Union only:
    To evaluate the effect of atogepant 30 mg QD and atogepant 60 mg QD versus placebo on the impact of headaches on daily functioning as assessed by HIT-6.
    Per valutare l'effetto di atogepant 30 mg QD e atogepant 60 mg QD contro placebo per la profilassi del mal di testa.

    Per valutare l'effetto di atogepant 30 mg QD e atogepant 60 mg QD rispetto al placebo rispetto all'uso di farmaci in acuto.

    Per valutare l'effetto di atogepant 30 mg QD e atogepant 60 mg QD rispetto al placebo sulla percentuale di partecipanti con almeno il 50% riduzione dal basale nei giorni mensili di emicrania.

    Per valutare l'effetto di atogepant 30 mg QD e atogepant 60 mg QD rispetto al placebo sull'impatto dell'emicrania sulle attività quotidiane valutate dal punteggio MSQ v2.1 Role Function-Restrictive domain.

    Solo per l'Unione Europea:
    Per valutare l'effetto di atogepant 30 mg QD e atogepant 60 mg QD rispetto al placebo sull'impatto del mal di testa sul funzionamento quotidiano come valutato da HIT-6.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Pharmacokinetics

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Farmacocinetica
    E.3Principal inclusion criteria
    1.01 Male or female participants ages 18 (or age of legal majority) to 80 years, inclusive, at Visit 1
    2.01 At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
    2.02 Age of the participant at the time of migraine onset < 50 years
    2.03 History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
    2.04 4 to 14 migraine days in the 28-day baseline period per eDiary (Note: A randomization cap of 20% will be instituted to ensure that the planned randomized participants include no more than 20% of participants with 4 to <8 migraine days at baseline.)
    2.05 Completed at least 20 out of 28 days in the eDiary during the baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator's judgment.
    2.06 Participants must meet all the below 2 criteria. Participants must have:
    a. Failed oral migraine prophylaxis medications from 2 to 4 of the medication classes as listed below:
    i. Propranolol, metoprolol, atenolol, bisoprolol, timolol, or nadolol;
    ii. Topiramate;
    iii. Flunarizine;
    iv. Valproate or divalproex;
    v. Amitriptyline or nortriptyline;
    vi. Venlafaxine or desvenlafaxine;
    vii. Lisinopril;
    viii. Candesartan;
    ix. Locally approved products (eg, oxeterone or pizotifen)
    b. Failed one AND failed or be not suitable for a second treatment from a
    different medication class as listed below:
    i. Propranolol OR metoprolol;
    ii. Topiramate;
    iii. Flunarizine;
    iv. Amitriptyline
    2.07 At least 80% of the randomized participants need to meet the below criteria:
    Failed at least 2 treatments from different medication classes as listed below:
    i. Propranolol OR metoprolol;
    ii. Topiramate;
    iii. Flunarizine;
    iv. Amitriptyline
    3.01 Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
    A male participant must agree to use contraception during the intervention period and for at least 3 days after the last dose of study intervention refrain from donating sperm during this period.
    Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
    A female participant is eligible to participate if she is not pregnant (ie, has a negative urine pregnancy result at the Screening Visit (Visit 1) and Randomization Visit (Visit 2), is not planning to become pregnant during the course of the study, is not breastfeeding, and fulfills at least one of the following conditions:
    a. Not a WOCBP as defined in Appendix 7 of the protocol
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance of using a medically acceptable and effective contraceptive method as defined in Appendix 7 of the protocol during the intervention period and for 3 days after the last dose of study intervention.
    4.01 Written informed consent and participant privacy information (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]) obtained from the participant prior to any study-related procedures.
    1.01 Partecipanti di sesso maschile o femminile di età compresa tra 18 (o maggiorenni) a 80 anni, compresi, alla Visita 1
    2.01 Almeno una storia di emicrania di 1 anno con o senza aura coerente con una diagnosi secondo l'ICHD-3, 2018.
    2.02 Età del partecipante al momento dell'insorgenza dell'emicrania <50 anni
    2.03 Storia di emicrania da 4 a 14 giorni al mese in media nei 3 mesi precedenti la visita 1 a giudizio dello Sperimentatore
    2.04 da 4 a 14 giorni di emicrania nel periodo di riferimento di 28 giorni per eDiary (Nota: sarà istituito un limite di randomizzazione del 20% per garantire che i partecipanti randomizzati pianificati includano non più del 20% dei partecipanti con 4-8 giorni di emicrania al basale.)
    2.05 Completato almeno 20 giorni su 28 nell'eDiary durante il periodo di riferimento ed è in grado di leggere, comprendere e completare i questionari di studio e l'eDiary secondo il giudizio dello sperimentatore.
    2.06 I partecipanti devono soddisfare tutti i 2 criteri seguenti. I partecipanti devono avere:
    a. Farmaci per la profilassi dell'emicrania orale non riusciti da 2 a 4 delle classi di farmaci elencate di seguito:
    i. Propranololo, metoprololo, atenololo, bisoprololo, timololo o nadololo;
    ii. topiramato;
    iii. Flunarizine;
    iv. Valproato o divalproex;
    v. Amitriptilina o nortriptilina;
    vi. Venlafaxina o desvenlafaxina;
    vii. Lisinopril;
    viii. candesartan;
    ix. Prodotti approvati localmente (ad es. Oxeterone o pizotifen)
    b. Un fallimento E fallito o non adatto per un secondo trattamento da una diversa classe di farmaci come elencato di seguito:
    i. Propranololo O metoprololo;
    ii. Topiramato;
    iii. Flunarizine;
    iv. Amitriptilina
    2.07 Almeno l'80% dei partecipanti randomizzati deve soddisfare i seguenti criteri:
    Falliti almeno 2 trattamenti di diverse classi di farmaci come di seguito elencati:
    i. Propranololo O metoprololo;
    ii. topiramato;
    iii. Flunarizine;
    iv. Amitriptilina
    3.01 Partecipanti di sesso maschile disposti a ridurre al minimo il rischio di indurre una gravidanza per la durata dello studio clinico e del periodo di follow-up.
    Un partecipante di sesso maschile deve accettare di usare la contraccezione durante il periodo di intervento e per almeno 3 giorni dopo l'ultima dose di intervento dello studio e astenersi dal donare lo sperma durante questo periodo.
    Donne partecipanti disposte a ridurre al minimo il rischio di indurre una gravidanza per la durata dello studio clinico e del periodo di follow-up.
    Una donna partecipante è ammessa a partecipare se non è incinta (vale a dire, ha un risultato di gravidanza nelle urine negativo alla Visita di screening (Visita 1) e Visita di randomizzazione (Visita 2), non ha intenzione di rimanere incinta durante il corso dello studio, non allatta al seno e soddisfa almeno una delle seguenti condizioni:
    a. Non un WOCBP come definito nell'Appendice 7 del protocollo
    O
    b. Un WOCBP che accetta di seguire la guida contraccettiva sull'uso di un metodo contraccettivo medico accettabile ed efficace come definito nell'Appendice 7 del protocollo durante il periodo di intervento e per 3 giorni dopo l'ultima dose dell'intervento di studio.
    4.01 Consenso informato scritto e informazioni sulla privacy dei partecipanti (ad es. Autorizzazione scritta per l'uso e il rilascio di informazioni sugli studi sulla salute e la ricerca [centri statunitensi] e consenso scritto sulla protezione dei dati [centri dell'UE]) ottenuti dal partecipante prima di qualsiasi procedura relativa allo studio.
    E.4Principal exclusion criteria
    Due to size constraints of this section, for the full exclusion criteria verbiage, please refer to section 5.2 of the protocol
    1.01 Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
    1.02 Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
    1.03 In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
    1.04 History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
    1.05 History of any prior gastrointestinal procedures or gastrointestinal conditions that may affect the absorption or metabolism of study intervention; participants with prior gastric bariatric interventions which have been reversed are not excluded
    1.06 Clinically significant cardiovascular or cerebrovascular disease per the investigator's opinion
    1.07 Significant risk of self-harm based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants must be excluded if they report suicidal ideation with intent, with or without a plan, in the past 6 months or report suicidal behavior in the 6 months prior to Visit 1 or Visit 2 assessments
    1.08 At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
    2.01 Has = 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
    2.02 Has = 15 headache days in the 28-day baseline period per eDiary
    2.03 Difficulty distinguishing migraine headaches from tension-type or
    other headaches
    2.04 Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
    2.05 Has a current diagnosis of chronic migraine, new persistent daily
    headache, trigeminal autonomic cephalgia, or painful cranial neuropathy as defined by ICHD-3, 2018
    3.01 Usage during 30 days prior to Visit 1 and throughout the study period of and requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment. This includes concomitant
    medications with demonstrated efficacy for the prevention of migraine regardless of indication.
    3.02 Usage of therapeutic or cosmetic botulinum toxin injections into areas of the head, face, or neck within 6 months prior to Visit 1 and throughout the study period.
    3.03 Usage of butalbital-containing analgesics >2 days/month, triptans or ergots = 10 days/month, or simple analgesics = 15 days/month, or any usage of opioid-containing medications in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period is excluded.
    3.04 Previous exposure to:
    • Atogepant
    • Injectable monoclonal antibodies blocking the CGRP pathway within the last 6 months prior to Visit 1
    • Ubrogepant
    • Rimegepant
    • Any other oral investigational CGRP-RA
    3.05 History of hypersensitivity or clinically significant adverse reaction to a CGRP-RA or hypersensitivity to any component of the study interventions.
    4.01 Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1
    5.01 Hypertension as defined by sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once
    5.02 An ECG with clinically significant abnormalities at screening as determined by the investigator
    5.03 QTcF > 450 msec for males and QTcF > 470 msec for females at Visit 1 based on the ECG report of the central reviewer
    5.04 Clinically signifi...
    A causa dei vincoli di dimensione di questa sezione, per il verbale completo dei criteri di esclusione, fare riferimento alla sezione 5.2 del protocollo
    1.01 Qualsiasi malattia ematologica, endocrina, polmonare, epatica, gastrointestinale o neurologica clinicamente significativa
    1.02 Il partecipante ha qualsiasi altra condizione di dolore concomitante che, secondo l'opinione dello sperimentatore, può avere un impatto significativo sull'attuale disturbo del mal di testa
    1.03 Secondo il parere dello sperimentatore, confondere condizioni psichiatriche, demenza, epilessia o disturbi neurologici significativi diversi dall'emicrania
    1.04 Storia di tumore maligno nei 5 anni precedenti alla Visita 1, ad eccezione del carcinoma cutaneo a cellule basali o squamose adeguatamente trattato o carcinoma cervicale in situ
    1.05 Storia di eventuali precedenti procedure gastrointestinali o condizioni gastrointestinali che possono influenzare l'assorbimento o il metabolismo dell'intervento dello studio; i partecipanti con precedenti interventi bariatrici gastrici che sono stati invertiti non sono esclusi
    1.06 Malattia cardiovascolare o cerebrovascolare clinicamente significativa secondo l'opinione dello sperimentatore
    1.07 Rischio significativo di autolesionismo basato su colloquio clinico e risposte sul C-SSRS, o di danno ad altri secondo l'opinione dello sperimentatore; i partecipanti devono essere esclusi se segnalano idee suicidarie con intenzione, con o senza un piano, negli ultimi 6 mesi o segnalano comportamenti suicidari nei 6 mesi precedenti le valutazioni di Visita 1 o Visita 2
    1.08 Alla visita 1, un utente di droghe ricreative o illecite o ha avuto una storia nell'ultimo anno di abuso o dipendenza da droghe o alcol
    2.01 Ha = 15 giorni di mal di testa al mese in media nei 3 mesi precedenti la Visita 1 a giudizio dell'investigatore
    2.02 Ha = 15 giorni di mal di testa nel periodo di riferimento di 28 giorni per eDiary
    2.03 Difficoltà a distinguere l'emicrania dal tipo di tensione o
    altri mal di testa
    2.04 Ha una storia di emicrania accompagnata da diplopia o diminuzione del livello di coscienza o emicrania retinica come definito da ICHD-3, 2018
    2.05 Ha una diagnosi attuale di emicrania cronica, nuova persistenza quotidiana di cefalea, cefalgia autonoma trigeminale o neuropatia cranica dolorosa come definito da ICHD-3, 2018
    3.01 Utilizzo durante 30 giorni prima della Visita 1 e per tutto il periodo di studio e requisiti per qualsiasi farmaco, dieta o trattamento non farmacologico che è nell'elenco dei farmaci o trattamenti concomitanti vietati che non possono essere sospesi o passati a un trattamento o trattamento alternativo ammissibile . Questo include farmaci concomitanti con efficacia dimostrata per la prevenzione dell'emicrania indipendentemente dall'indicazione.
    3.02 Uso di iniezioni di tossina botulinica terapeutiche o cosmetiche nelle aree della testa, del viso o del collo entro 6 mesi prima della Visita 1 e per tutto il periodo di studio.
    3.03 Uso di analgesici contenenti butalbital> 2 giorni/mese, triptani o ergot = 10 giorni/mese o analgesici semplici = 15 giorni/mese o qualsiasi uso di farmaci contenenti oppioidi nei 3 mesi precedenti alla Visita 1 secondo il giudizio dello sperimentatore o durante il periodo di riferimento è escluso.
    3.04 Esposizione precedente a:
    • Atogepant
    • Anticorpi monoclonali iniettabili che bloccano il percorso CGRP negli ultimi 6 mesi prima della Visita 1
    • Ubrogepant
    • Rimegepant
    • Qualsiasi altro CGRP-RA sperimentale orale
    3.05 Storia di ipersensibilità o reazione avversa clinicamente significativa a un CGRP-RA o ipersensibilità a qualsiasi componente degli interventi dello studio.
    4.01 Attualmente partecipa o ha partecipato a uno studio con un composto o dispositivo sperimentale entro 30 giorni prima della Visita 1
    5.01 Ipertensione definita dalla pressione arteriosa sistolica seduta> 160 mm Hg o pressione arteriosa diastolica seduta> 100 mm Hg in Visite 1 o Visita 2. Le misurazioni del se...
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in mean monthly migraine days across the 12-week treatment period.
    Variazione rispetto al basale in giorni di emicrania mensili medi durante il periodo di trattamento di 12 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12. Baseline is defined as the number of migraine days during the last 28 days of the baseline phase (ie, Day -28 to -1)
    Dal basale alla settimana 12. Il basale è definito come il numero di giorni di emicrania durante gli ultimi 28 giorni della fase basale (ovvero, da -28 a -1)
    E.5.2Secondary end point(s)
    Change from baseline in mean monthly headache days across the 12-week treatment period.

    Change from baseline in mean monthly acute medication use days across
    the 12-week treatment period.

    Achievement of at least a 50% reduction in mean monthly migraine days
    across the 12-week treatment period.

    Change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12

    Change from baseline in the HIT-6 total score at Week 12
    Variazione rispetto al basale nei giorni medi mensili di mal di testa durante il periodo di trattamento di 12 settimane.

    Variazione rispetto al basale nei giorni medi mensili di uso acuto di farmaci in tutto il periodo di trattamento di 12 settimane.

    Ottenimento di una riduzione di almeno il 50% nei giorni di emicrania mensili medi durante il periodo di trattamento di 12 settimane.

    Variazione rispetto al basale nel punteggio di dominio con funzioni limitate della funzione ruolo MSQ v2.1 alla settimana 12

    Variazione rispetto al basale del punteggio totale HIT-6 alla settimana 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12. Baseline is defined as the number of migraine days during the last 28 days of the baseline phase (ie, Day -28 to -1)
    Dal basale alla settimana 12. Il basale è definito come il numero di giorni di emicrania durante gli ultimi 28 giorni della fase basale (ovvero, da -28 a -1)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability of atogepant will also be evaluated
    Sarà valutata anche la tollerabilità di atogepant
    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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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 Information not present in EudraCT
    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
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    United Kingdom
    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 the study is defined as the date of the last visit of the last participant in the study.

    A participant is considered to have completed the study if he/she has not been terminated early and has completed all phases of the study including the last scheduled procedure shown in the schedule of activities.
    La fine dello studio è definita come la data dell'ultima visita dell'ultimo partecipante allo studio.

    Si ritiene che un partecipante abbia completato lo studio se non è stato terminato in anticipo e ha completato tutte le fasi dello studio, inclusa l'ultima procedura programmata indicata nel programma delle attività.
    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 months10
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days8
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 564
    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 state108
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 430
    F.4.2.2In the whole clinical trial 627
    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)
    No study intervention will be administered after the end of the study.

    Following the end of study, the participant may be treated as per usual practice and standard of care or referred to the participant's treating physician/general practitioner for further medical care at the investigator's discretion.
    Nessun intervento di studio verrà somministrato dopo la fine dello studio.

    Dopo la fine dello studio, il partecipante può essere trattato secondo la prassi e lo standard di cura abituali o indirizzato al medico curante/medico generico del partecipante per ulteriori cure mediche a discrezione dello sperimentatore.
    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 Decision2020-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
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