E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cronic or Episodic Migraine (Migraine without aura, migraine with aura, or chronic migraine) |
Emicrania cronica o episodica (emicrania senza aura, emicrania con aura o emicrania cronica) |
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E.1.1.1 | Medical condition in easily understood language |
Cronic or Episodic Migraine |
Emicrania cronica o episodica |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10027603 |
E.1.2 | Term | Migraine headaches |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052787 |
E.1.2 | Term | Migraine without aura |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027607 |
E.1.2 | Term | Migraine with aura |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066636 |
E.1.2 | Term | Chronic migraine |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10032066 |
E.1.2 | Term | Other forms of migraine |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and tolerability of treatment with atogepant 60 mg once daily when administered over 52 weeks for the prevention of migraine in participants with CM or EM. |
Per valutare la sicurezza e la tollerabilità del trattamento con atogepant 60 mg una volta al giorno quando somministrato in 52 settimane per la prevenzione dell'emicrania nei partecipanti con CM o EM. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures;
2. Participants must be using a medically acceptable and effective method of birth control during the course of the entire study, as defined in Section 4.5.2 of the protocol;
3. Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations (eg, noncompliance to protocol-required procedures) and who did not experience an AE that, in the investigator’s opinion, may indicate an unacceptable safety risk. |
1. Consenso informato scritto e informazioni sulla privacy dei partecipanti (ad esempio, autorizzazione scritta per l'uso e il rilascio di informazioni sulla salute e sugli studi di ricerca) ottenuti dal partecipante prima dell'inizio di qualsiasi procedura specifica per lo studio; 2. I partecipanti devono utilizzare un metodo di controllo delle nascite accettabile dal punto di vista medico ed efficace durante l'intero studio, come definito nella Sezione 4.5.2 del protocollo; 3. Partecipanti idonei che hanno completato il periodo di trattamento in doppio cieco (Visita 7) e il periodo di follow-up (Visita 8), se applicabile, a seconda dell'orario di inizio dello studio, dello Studio 3101-303-002 o dello Studio 3101-304 -002 senza deviazioni significative dal protocollo (p. Es., Non conformità alle procedure richieste dal protocollo) e che non hanno avuto un evento avverso che, a parere dello sperimentatore, potrebbe indicare un rischio per la sicurezza inaccettabile. |
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E.4 | Principal exclusion criteria |
1. Requirement for any medication, diet (ie, grapefruit or grapefruit juice), 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.
Exception: participants from lead-in Study 3101-303-002 taking only 1 migraine
prevention medication at a stable, well-tolerated dose during the lead-in study; the medication may be continued at the same dose or discontinued;
2. Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. WOCBP must have a negative urine pregnancy test at Visit 1;
3. An ECG with clinically significant abnormalities at Visit 1 as determined by the
investigator;
4. Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic
BP > 100 mm Hg at Visit 1. Vital sign measurements that exceed these limits may be repeated only once;
5. 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 (ie, Type 4 or 5 on the C-SSRS) since the last visit;
6. Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease;
7. Participant has a condition or is in a situation which in the investigator's opinion may put the participant at significant risk, may confound the study results, or may interfere significantly with participation in the study;
8. Any medical or other reasons (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator’s opinion, might indicate that the participant is unsuitable for participation in the study. |
1. Requisiti per qualsiasi farmaco, dieta (ad es. Pompelmo o succo di pompelmo) o trattamento non farmacologico che si trova nell'elenco di farmaci o trattamenti concomitanti proibiti che non possono essere interrotti o trasferiti a un farmaco o trattamento alternativo consentito. Eccezione: partecipanti allo studio introduttivo 3101-303-002 che assumevano solo 1 emicrania farmaci di prevenzione a una dose stabile e ben tollerata durante lo studio introduttivo; il farmaco può essere continuato alla stessa dose o interrotto; 2. La partecipante è incinta, sta pianificando una gravidanza durante il corso dello studio o sta allattando. WOCBP deve avere un test di gravidanza sulle urine negativo alla Visita 1; 3. Un ECG con anomalie clinicamente significative alla Visita 1 come determinato da investigatore; 4. Ipertensione definita da pressione sistolica da seduti> 160 mm Hg o diastolica da seduti PA> 100 mm Hg alla visita 1. Le misurazioni dei segni vitali che superano questi limiti possono essere ripetute una sola volta; 5. Rischio significativo di autolesionismo basato su interviste cliniche e risposte sul C-SSRS, o di danno ad altri secondo l'opinione dello sperimentatore; i partecipanti devono essere esclusi se riferiscono di ideazione suicidaria intenzionale, con o senza un piano (ad esempio, Tipo 4 o 5 sul C-SSRS) dall'ultima visita; 6. Partecipanti con malattie ematologiche, endocrine, cardiovascolari, polmonari, renali, epatiche, gastrointestinali o neurologiche clinicamente significative; 7. Il partecipante ha una condizione o si trova in una situazione che, a giudizio dello sperimentatore, potrebbe metterlo a rischio significativo, confondere i risultati dello studio o interferire in modo significativo con la partecipazione allo studio; 8. Qualsiasi motivo medico o di altro tipo (ad esempio, improbabile aderire alle procedure dello studio, mantenere gli appuntamenti o pianificare un trasferimento durante lo studio) che, a parere dello sperimentatore, potrebbe indicare che il partecipante non è idoneo alla partecipazione allo studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Since the primary objective of this study is to assess the long-term safety and tolerability of atogepant treatment, efficacy variables are not classified as primary, secondary, or additional.
Efficacy endpoints for long-term efficacy evaluation in the atogepant arm are listed below:
- Change from baseline in monthly migraine days for each monthly period (4-week intervals after Visits 4, 6 and 8);
- Change from baseline in monthly headache days at each monthly period (4-week intervals after Visits 4, 6 and 8);
- Change from baseline in monthly acute medication use days at each monthly period (4-week intervals after Visits 4, 6 and 8);
- Change from baseline in monthly triptan use days at each monthly period (4-week intervals after Visits 4, 6 and 8);
- = 25%, = 30%, = 50%, = 75%, and 100% improvement (decrease) of monthly migraine days, at each monthly period (4-week intervals after Visits 4, 6 and 8);
- Change from baseline in monthly moderate/severe headache days at each monthly period (4-week intervals after Visits 4, 6 and 8) |
Poiché l'obiettivo principale di questo studio è valutare la sicurezza e la tollerabilità a lungo termine del trattamento atogepant, le variabili di efficacia non sono classificate come primarie, secondarie o aggiuntive.
Gli endpoint di efficacia per la valutazione dell'efficacia a lungo termine nel braccio atogepant sono elencati di seguito:
- Variazione dal basale dei giorni mensili di emicrania per ciascun periodo mensile (intervalli di 4 settimane dopo le visite 4, 6 e 8); - Variazione rispetto al basale dei giorni mensili di cefalea ad ogni periodo mensile (intervalli di 4 settimane dopo le visite 4, 6 e 8); - Variazione rispetto al basale dei giorni mensili di consumo acuto di farmaci in ciascun periodo mensile (intervalli di 4 settimane dopo le visite 4, 6 e 8); - Variazione rispetto al basale dei giorni di utilizzo mensile dei triptani in ciascun periodo mensile (intervalli di 4 settimane dopo le visite 4, 6 e 8); - = 25%, = 30%, = 50%, = 75% e 100% di miglioramento (diminuzione) dei giorni mensili di emicrania, ad ogni periodo mensile (intervalli di 4 settimane dopo le visite 4, 6 e 8); - Variazione dal basale nei giorni mensili di cefalea moderata / grave in ciascun periodo mensile (intervalli di 4 settimane dopo le visite 4, 6 e 8) More about this source textSource text required for additional translation information Send feedback Side panels History Saved Contribute |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
As described within the list of endpoints |
Come descritto nell'elenco degli endpoint |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability of atogepant will also be evaluated |
Translation results Verrà valutata anche la tollerabilità dell'atogepant |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 107 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Korea, Republic of |
Russian Federation |
Taiwan |
United States |
Denmark |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Spain |
Sweden |
United Kingdom |
Czechia |
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E.8.7 | Trial 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
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The end of the study is defined as the date of the last visit of the last participant in the study.
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La fine dello studio è definita come la data dell'ultima visita dell'ultimo partecipante allo studio. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |