E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Episodic Migraine Headache |
Migraña Episodica |
|
E.1.1.1 | Medical condition in easily understood language |
Migraine Headaches |
Migraña |
|
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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027602 |
E.1.2 | Term | Migraine headache |
E.1.2 | System Organ Class | 100000004852 |
|
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 test the hypothesis that at least 1 dose of LY2951742 is superior to placebo in the prevention of migraine headache in patients with episodic migraine. |
Evaluar la hipótesis de que al menos 1 dosis de LY2951742 (120 o 240 mg/mes) es superior al placebo en términos de prevención de la migraña, en pacientes con migraña episódica. |
|
E.2.2 | Secondary objectives of the trial |
To compare LY2951742 with placebo with respect to 50% response rate To compare LY2951742 with placebo with respect to 75% response rate To compare LY2951742 with placebo with respect to 100% response rate To compare LY2951742 with placebo with respect to change in functioning To compare LY2951742 with placebo with respect to change in use of acute (abortive) migraine treatment To compare LY2951742 with placebo with respect to change in global severity of migraine condition |
- Comparar LY2951742 con el placebo en lo que respecta a la tasa de respuesta del 50 %. - Comparar LY2951742 con el placebo en lo que respecta a la tasa de respuesta del 75 %. - Comparar LY2951742 con el placebo en lo que respecta a la tasa de respuesta del 100 %. - Comparar LY2951742 con el placebo en lo que respecta a la variación de la función. - Comparar LY2951742 con el placebo en lo que respecta a la variación en el uso de tratamiento urgente (abortivo) de la migraña. - Comparar LY2951742 con el placebo en lo que respecta a la variación en la intensidad global de la migraña. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are 18 to 65 years of age (inclusive) Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year Migraine onset prior to age 50. |
Pacientes de 18-65 años (ambos inclusive) en el momento de la selección. Habérsele diagnosticado migraña, de acuerdo con las directrices de la International Classification of Headache Disorders (ICHD)-3 beta (1.1 o 1.2) de la International Headache Society (IHS), con antecedentes de migrañas al menos durante el año previo a la visita 1 y aparición de las migrañas antes de los 50 años. |
|
E.4 | Principal exclusion criteria |
Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. Current use or prior exposure to LY2951742 or another CGRP antibody Are currently receiving medication or other treatments for the prevention of migraine headaches. Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta. |
Estar participando en la actualidad en cualquier otro ensayo clínico en el que se administre un producto en fase de investigación o en cualquier otro tipo de investigación médica que se considere que no es compatible con el estudio, desde un punto de vista científico o médico. Estar recibiendo o haber recibido LY2951742 u otro anticuerpo frente al CGRP Estar recibiendo de forma simultánea otros fármacos o tratamientos para prevenir las migrañas Hipersensibilidad a diversos fármacos, anticuerpos monoclonales u otras proteínas terapéuticas, o a LY2951742 Antecedentes (persistentes y diarios) de cefalea, cefalea en racimos o subtipos de migraña, incluidas la migraña hemipléjica (esporádica o familiar), la migraña oftalmopléjica y la migraña con aura del troncoencéfalo (migraña basilar), de acuerdo con los criterios ICHD-3 beta de la IHS. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The overall mean change from baseline in the number of monthly migraine headache days during the 6-month double-blind treatment phase |
El criterio principal de valoración de la eficacia es el promedio global de la variación respecto al período basal en el número de días al mes con migraña, durante la fase de tratamiento doble ciego de 6 meses. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6-month double-blind treatment phase |
6- meses fase de tratamiento doble ciego |
|
E.5.2 | Secondary end point(s) |
The proportion of patients with reduction from baseline ?50% in migraine headache days during the 6-month double-blind treatment phase The proportion of patients with reduction from baseline ?75% in monthly migraine headache days during the 6-month double-blind treatment phase The proportion of patients with a 100% reduction from baseline in monthly migraine headache days during the 6-month double-blind treatment phase Mean change from baseline in the total score of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) (average of Months 4, 5 and 6) Mean change from baseline in the number of migraine headache days requiring medication for the acute treatment of migraine or headache during the 6-month double-blind treatment phase The mean change from baseline in the Patient Global Impression of Severity (PGI-S) score (average of Months 4, 5, and 6) |
En relación con el análisis de las respuestas del 50 %, 75 % y 100 %, se estimará el porcentaje de pacientes que alcancen los criterios de respuesta durante la fase de tratamiento doble ciego de 6 meses de duración. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6-month double-blind treatment phase |
6 meses fase de tratamientos doble ciego |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity |
Inmunogeneidad |
|
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 | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 |
Argentina |
Brazil |
Czech Republic |
Germany |
Israel |
Korea, Democratic People's Republic of |
Mexico |
Netherlands |
Puerto Rico |
Spain |
Taiwan |
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 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 19 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 19 |
E.8.9.2 | In all countries concerned by the trial days | 0 |