E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Cluster Headache |
Cefalea a grappolo cronica |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Cluster Headache |
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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009698 |
E.1.2 | Term | Cluster headaches |
E.1.2 | System Organ Class | 100000004852 |
|
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 assess the efficacy of LY2951742 compared with placebo in reducing the frequency of weekly cluster headache attacks |
Valutare l'efficacia di LY2951742 rispetto al placebo nella riduzione della frequenza degli attacchi settimanali di cefalea a grappolo |
|
E.2.2 | Secondary objectives of the trial |
To assess the efficacy of LY2951742 compared with placebo on the Patient Global Impression of Improvement (PGI-I).
To evaluate the safety and tolerability of LY2951742. |
Valutare l'efficacia di LY2951742 rispetto al placebo sulla base del questionario sull'impressione globale di miglioramento del paziente (PGI-I, patient Global Impression of Improvement). Valutare la sicurezza e la tollerabilità di LY2951742 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Participants (or patients) with a history of chronc cluster headache occuring without a remission period, or with remissions lasting less than 1 month for at least 1 year.
• Participants (or patients) are able to distinguish cluster headache
attacks from other headaches. |
Pazienti con un'anamnesi pregressa di cefalea a grappolo cronica in assenza di periodi di remissione o con periodi di remissione della durata minore a un mese, per almeno un anno. Pazienti in grado di distinguere gli attacchi di cefalea a grappolo da altri tipi di cefalee. |
|
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.
• Current use or any prior exposure to any CGRP antibody, any antibody
to the CGRP receptor, or antibody to nerve growth factor (NGF).
• Are taking indomethacin and/or are suspected of having another
distinct trigeminal autonomic cephalalgia
• 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. |
Attuale partecipazione ad uno studio clinico che coinvolge un qualunque farmaco sperimentale o dispositivo, oppure interruzione di tale studio negli ultimi 30 giorni. • Utilizzo attuale o pregresso di qualsiasi anticorpo che si leghi al peptide correlato al gene della calcitonina (CGRP), o al recettore del peptide correlato al gene della calcitonina, o al fattore di crescita nervoso (NGF). • Assunzione di indometacina e/o sospetto che il paziente soffra di una cefalalgia autonomico-trigeminale distinta. • Anamnesi pregressa positiva a varianti di emicrania che potrebbero implicare o essere confuse con ischemia. • Ipersensibilità nota a molteplici farmaci, anticorpi monoclonali o altre proteine terapeutiche. • Presenza attuale o storia medica di altre patologie indici di un problema medico che potrebbe precludere la partecipazione allo studio. • Evidenza di significativa malattia psichiatrica attiva o instabile, a giudizio dello Sperimentatore • Donne in gravidanza o allattamento. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the overall mean change from baseline in weekly cluster headache attack frequency during the 12-week double-blind treatment phase with LY2951742 compared with placebo |
L’end point primario è il cambiamento medio complessivo rispetto al baseline della frequenza degli attacchi settimanali di cefalea a grappolo durante le 12 settimane della fase di trattamento in doppio cieco, con LY2951742 rispetto al placebo. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline to week 12 |
Dalla visita basale alla settimana 12 |
|
E.5.2 | Secondary end point(s) |
Patients with a 50% or greater reduction in the weekly number of cluster headache attacks
Patients with a 30% or greater reduction in the weekly number of
cluster headache attacks
Mean change in the weekly cluster headache attack frequency
Treatment emergent adverse events
Clinical Laboratory and vital signs
Anti-LY2951742 antibodies
Proportion of patients reporting a score of 1 ("very much better") or 2
("much better") on the Patient Global Impression of Improvement (PGI-I) |
Pazienti con una riduzione di almeno il 50% della frequenza degli attacchi settimanali di cefalea a grappolo. Pazienti con una riduzione di almeno il 30% della frequenza degli attacchi settimanali di cefalea a grappolo. Variazione media della frequenza degli attacchi settimanali di cefalea a grappolo Eventi avversi emersi durante il trattamento. Esami clinici di Laboratorio e segni vitali. Anticorpi anti-LY2951742. Percentuale di pazienti che presentano un punteggio pari a 1 (“nettamente meglio”) o a 2 (“molto meglio”) del questionario sull’impressione globale di miglioramento del paziente (PGI-I). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For first six secondary endpoints from baseline through week 12
For PGI-I secondary endpoint: at month 1, 2, and 3. |
Per i primi sei endpoints secondari; dalla visita basale alla settimana 12 Per l'endpoint secondario sul PGI-I; ai mesi 1, 2 e 3 |
|
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Con una fase di estensione a lungo termine in aperto |
With an open label Long-Term Extension Phase |
|
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
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 |
Belgium |
Canada |
Denmark |
Finland |
France |
Germany |
Greece |
Italy |
Netherlands |
Spain |
United Kingdom |
United States |
|
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
|
LVLS this is the end of the trial. |
LVLS |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |