E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Episodic Cluster Headache, Chronic Cluster Headache |
Cefalea a grappolo episodica, cefalea a grappolo cronica |
|
E.1.1.1 | Medical condition in easily understood language |
Episodic Cluster Headache, Chronic Cluster Headache |
Cefalea a grappolo episodica, cefalea a grappolo cronica |
|
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 | 24.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10059133 |
E.1.2 | Term | Cluster headache |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety of open-label galcanezumab within the context of dosing during expected medical practice in eligible patients with episodic or chronic cluster headache. |
Valutare la sicurezza di Galcanezumab in aperto nel contesto del dosaggio durante la pratica medica prevista nei pazienti eleggibili colpiti da cefalea a grappolo cronica o episodica. |
|
E.2.2 | Secondary objectives of the trial |
1. To characterize the reasons for discontinuation and AEs of interest for galcanezumab.
2. To characterize the immunogenicity of galcanezumab. |
1. Caratterizzare le ragioni dell'interruzione e gli AE di interesse di galcanezumab 2. Caratterizzare l'immunogenicità di galcanezumab |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Participants who participated in and completed either Study CGAL or Study CGAM.
•Investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements.
|
- Partecipanti che hanno preso parte allo studio CGAL o lo studio CGAM. - Lo sperimentatore ritiene che il partecipante sia affidabile nel seguire tutte le procedure dello studio, presentarsi a tutte le visite e rispettare i requisiti dello studio. |
|
E.4 | Principal exclusion criteria |
•Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device (with the exception of Study CGAL or Study CGAM).
•Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF) (with the exception of Study CGAL or Study CGAM).
•A history of migraine variants that could implicate or could be confused with ischemia.
•Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
•A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
•Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
•Women who are pregnant or nursing.
|
•Arruolamento corrente o interrotto entro i 30 giorni precedenti in uno studio clinico con coinvolgimento di un farmaco o dispositivo sperimentale (con l'eccezione dello Studio CGAL o dello Studio CGAM). •Utilizzo corrente o precedente esposizione all'anticorpo per il peptide correlato al gene della calcitonina (CGRP), all'anticorpo per il recettore CGRP o all'anticorpo per il fattore di crescita nervoso (NGF) (con l'eccezione dello Studio CGAL o dello Studio CGAM). •Un'anamnesi di varianti di emicrania che possono implicare o essere confuse con ischemia. •Ipersensibilità nota a più farmaci, anticorpi monoclonali o altre proteine terapeutiche. •Anamnesi o presenza di un'altra condizione medica indicante un problema clinico che precluda la partecipazione allo studio. •Evidenza di malattia psichiatrica significativa attiva o instabile a giudizio dello sperimentatore. •Donne in gravidanza o allattamento. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1.Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious AEs (SAEs)
[Time Frame: Baseline through End of Study
2.Number of Participants With Suicidal Ideation and Behaviors Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
[Time Frame: Baseline through End of Study
|
1) Numero di partecipanti con eventi avversi emersi durante il trattamento (AE) o AE seri (SAE) Dal basale alla fine dello studio
2) Numero di partecipanti con ideazione o comportamento suicidari raccolti con la scala Columbia - Suicide Severity Rating Scale(C-SSRS) Dal basale alla fine dello studio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline through End of Study (Approximately 5 Years) |
Dal basale alla fine dello studio (approssimativamente 5 anni) |
|
E.5.2 | Secondary end point(s) |
Number of Participants with Treatment Emergent Anti-Galcanezumab Antibodies |
Numero di partecipanti con anticorpi anti galcanezumab emersi durante il trattamento |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline through End of Study (Approximately 5 Years) |
Dal basale alla fine dello studio (approssimativamente 5 anni) |
|
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 | No |
E.6.6 | Pharmacokinetic | Yes |
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 | 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 | 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 | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 |
Canada |
United States |
Belgium |
Denmark |
Finland |
France |
Germany |
Italy |
Netherlands |
Spain |
United Kingdom |
Greece |
|
E.8.7 | Trial 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |