E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Episodic Cluster Headache |
Cefalea en Racimos Episódica |
|
E.1.1.1 | Medical condition in easily understood language |
Episodic Cluster Headache |
Cefalea en Racimos Episódica |
|
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 | 18.0 |
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 300 mg compared to placebo in reducing the frequency of weekly cluster headache attacks. |
Comparar la eficacia de LY2951742 300 mg con la del placebo en términos de reducción de la frecuencia semanal de las crisis de cefalea en racimos |
|
E.2.2 | Secondary objectives of the trial |
To assess the efficacy of LY2951742 300 mg compared to placebo on the Patient Global Impression of Improvement (PGI-I)
To evaluate the safety and tolerability of LY2951742 |
Comparar la eficacia de LY2951742 300 mg con la del placebo la escala de ?Impresión global de mejoría percibida por el paciente? (PGI-I) Evaluar la seguridad y eficacia de LY2951742 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Participants (or patients) with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of ?1 month.
? Participants (or patients) are able to distinguish cluster headache attacks from other headaches |
? Participantes (o pacientes) con antecedentes de cefalea en racimos crónica con al menos dos crisis durante los últimos 7 dias a un año (sin tratar) y separados por periodos de remision libre de dolor de ?1 mes ? Participantes (o pacientes) capaces de distinguir las crisis de cefalea en racimos de otros tipos de cefaleas |
|
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. |
? Estar participando en la actualidad o haber abandonado en el transcurso de los 30 días un ensayo clínico en el que se administre un fármaco o se utilice un producto sanitario en fase de investigación.
? Estar recibiendo en la actualidad o haber recibido algún anticuerpo frente al péptido CGRP , algún anticuerpo frente al receptor del CGRP o un anticuerpo frente al factor de crecimiento nervioso (NGF),
? Estar recibiendo indometacina o posible presencia de otra cefalalgia neurovegetativa del trigémino bien diferenciada
? Antecedentes permanentes de variantes de migraña que puedan implicar la aparición de isquemia o confundirse con esta
? Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins
? Hipersensibilidad a múltiples sustancias farmacéuticas, anticuerpos monoclonales u otras proteínas terapéuticas.
? Historia o presencia de otra enfermedad médica que indica un problema médico que impida la participación en el estudio
? Datos sugestivos de enfermedad psiquiátrica inestable o activa significativa, en opinión del investigador.
? Mujeres embarazadas o en período de lactancia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be mean change in weekly cluster headache attack frequency with LY2951742 compared with placebo. |
El criterio de valoración es la reducción de la frecuencia de las crisis de cefalea en racimos cada semana con LY2951742 comparado con placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline to week 3 |
Desde el inicio hasta la semana 3 |
|
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) |
Pacientes con un 50% o más de reducción en el número semanal de los ataques de cefalea en racimos
Pacientes con un 30% o más de reducción en el número semanal de los ataques de cefalea en racimos
Cambio en la frecuencia de los ataques de cefalea en racimos cada semana
Acontecimientos adversos surgidos durante el tratamiento
Análisis clínicos y constantes vitales
Anticuerpos LY2951742
Porcentaje de pacientes que en la semana 4 y en la semana 8 notifiquen una puntuación de 1 (?muchísimo mejor?) o de 2 (?mucho mejor?) en la escala de ?Impresión global de mejoría percibida por el paciente? (PGI-I) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For first six secondary endpoints from baseline through week 8
For PGI-I secondary endpoint: at weeks 4 and 8 |
Para los seis primeros criterios de valoracion desde el período basal hasta la semana 8. Para el segundo criterio de valoracion ?Impresión global de mejoría percibida por el paciente? (PGI-I): en las semanas 4 y 8 |
|
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 | 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 | 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 | 20 |
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 | No |
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 |
Denmark |
Finland |
France |
Germany |
Italy |
Spain |
United Kingdom |
|
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. |
Ultima Visita Ultimo Paciente |
|
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 | |
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 |