E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Episodic Migraine |
Emicrania Episodica |
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E.1.1.1 | Medical condition in easily understood language |
Migraine headache |
Emicrania |
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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 | LLT |
E.1.2 | Classification code | 10027602 |
E.1.2 | Term | Migraine headache |
E.1.2 | System Organ Class | 100000004852 |
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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 demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the following populations with migraine: the overall pediatric population (6 to 17 year-olds) or the adolescent population (12 to 17 year-olds). |
Dimostrare la superiorità di galcanezumab rispetto al placebo nella prevenzione dell’emicrania in (almeno) 1 delle seguenti popolazioni con emicrania: la popolazione pediatrica complessiva (6-17 anni) o la popolazione adolescente (12-17 anni). |
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E.2.2 | Secondary objectives of the trial |
to evaluate the efficacy and safety of galcanezumab |
valutare la sicurezza e efficacia di galcanezumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 [2018]), with a history of migraine headaches of at least 6 months prior to screening. |
• Diagnosi di emicrania con o senza aura secondo la definizione delle linee guida ICHD-3 dell’IHS (1.1 o 1.2 secondo l’ICHD-3 [2018]), con anamnesi di cefalea emicranica risalente ad almeno 6 mesi prima dello screening. |
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E.4 | Principal exclusion criteria |
• Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies, other than antibodies to calcitonin gene-related peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior to baseline.
• Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
• Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.
• History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine) as defined by IHS ICHD-3.
• History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
• Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
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• Partecipanti che assumono, o potrebbero assumere, anticorpi terapeutici nel corso dello studio (adalimumab, infliximab, trastuzumab, bevacizumab ecc.). L’uso pregresso di anticorpi terapeutici, diversi dagli anticorpi diretti contro il peptide correlato al gene della calcitonina (CGRP) o il relativo recettore, è consentito se avvenuto a più di 12 mesi dal basale. • Ipersensibilità nota a più farmaci, anticorpi monoclonali o altre proteine terapeutiche, a galcanezumab o ai relativi eccipienti. • Uso attuale o precedente esposizione a galcanezumab, un altro anticorpo diretto contro il CGRP o il relativo recettore, compresi i soggetti che hanno completato o si sono ritirati dal presente studio o da qualsiasi altro studio su anticorpi anti-CGRP. • Anamnesi di cefalea giornaliera persistente, cefalea a grappolo o sottotipi di emicrania tra cui emicrania emiplegica (sporadica o familiare) ed emicrania con aura del tronco encefalico (emicrania di tipo basilare) definite dai criteri ICHD-3 dell’IHS. • Anamnesi di importante lesione cranica o cervicale nei 6 mesi precedenti lo screening; o trauma cranico, subito in un qualsiasi momento, che sia associato a variazioni significative della qualità o della frequenza delle cefalee, compresa la nuova insorgenza di emicrania dopo il trauma cranico. • Partecipanti con anamnesi nota di tumori intracranici o malformazioni dello sviluppo, comprese le malformazioni di Chiari. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change from Baseline in the Number of Monthly Migraine Headache Days |
1. Variazione rispetto al basale del numero di giorni di cefalea emicranica al mese |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Time Frame: Baseline, 3 Months |
1. Time Frame: Baseline, 3 Mesi |
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E.5.2 | Secondary end point(s) |
2. Percentage of Participants with Reduction from Baseline =50%, =75% and 100% in Monthly Migraine Headache Days
3. Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
4. Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
5. Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
6. Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken
7. Patient Global Impression-Improvement (PGI-I) Rating
8. Change from Baseline in the Severity of Remaining Migraine Headaches per Month
9. Change from Baseline in the Number of Monthly Headache Days
10. Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score
11. Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score
12. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
13. Pharmacokinetics (PK): Serum Concentration of Galcanezumab
14. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
15. Percentage of Participants Developing Anti-Drug Antibodies
16. Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase |
2. Percentuale di partecipanti con una riduzione rispetto al basale =50%, =75% e 100% dei giorni di emicrania al mese 3. Variazione rispetto al basale del numero di giorni di cefalea emicranica al mese con nausea e/o vomito 4. Variazione rispetto al basale del numero di giorni di cefalea emicranica al mese con fotofobia e fonofobia 5. Variazione rispetto al basale del numero di giorni di cefalea emicranica al mese, con sintomi prodromici 6. Variazione rispetto al basale del numero di giorni di cefalea emicranica con utilizzo di medicinali per il trattamento in acuto della cefalea 7. Valutazione secondo il questionario PGI-I (Patient Global Impression-Improvement) 8. Variazione rispetto al basale della gravità delle cefalee emicraniche rimanenti al mese 9. Variazione rispetto al basale del numero di giorni di cefalea al mese 10. Variazione rispetto al basale del punteggio totale al questionario PedsQL (Pediatric Quality of Life Inventory) 11. Variazione rispetto al basale del punteggio totale al questionario PedMIDAS (Pediatric Migraine Disability Assessment Test) 12. Percentuale di partecipanti con ideazioni e comportamenti suicidari valutati secondo il punteggio alla Scala della Columbia University per la valutazione della gravità del rischio di suicidio (C-SSRS) 13. Farmacocinetica (PK): concentrazioni sieriche di galcanezumab 14. Concentrazioni plasmatiche del peptide correlato al gene della calcitonina (CGRP) 15. Percentuale di partecipanti che sviluppano anticorpi anti-farmaco 16. Percentuale di partecipanti che iniziano ad assumere farmaci per la prevenzione dell’emicrania nella fase di follow-up post-trattamento |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2. Time Frame: 3 Months
3. Time Frame: Baseline, 3 Months
4. Time Frame: Baseline, 3 Months
5. Time Frame: Baseline, 3 Months
6. Time Frame: Baseline, 3 Months
7. Time Frame: Month 1 to Month 3
8. Time Frame: Baseline, 3 Months
9. Time Frame: Baseline, 3 Months
10. Time Frame: Baseline, 3 Months
11. Time Frame: Baseline, 3 Months
12. Time Frame: Baseline through 3 Months
13. Time Frame: Baseline through 3 Months
14. Time Frame: Baseline through 3 Months
15. Time Frame: Baseline through 3 Months
16. Time Frame: 16 Months |
2. Time Frame: 3 Months 3. Time Frame: Baseline, 3 Months 4. Time Frame: Baseline, 3 Months 5. Time Frame: Baseline, 3 Months 6. Time Frame: Baseline, 3 Months 7. Time Frame: Month 1 to Month 3 8. Time Frame: Baseline, 3 Months 9. Time Frame: Baseline, 3 Months 10. Time Frame: Baseline, 3 Months 11. Time Frame: Baseline, 3 Months 12. Time Frame: Baseline through 3 Months 13. Time Frame: Baseline through 3 Months 14. Time Frame: Baseline through 3 Months 15. Time Frame: Baseline through 3 Months 16. Time Frame: 16 Months |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
India |
Japan |
Mexico |
United States |
Denmark |
Germany |
Italy |
Spain |
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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
|
End of the trial is the date of the last visit or last scheduled procedure |
La fine dello studio è la data dell'ultima visita o dell'ultima procedura programmata |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 | 15 |