E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Migraine and medication overuse headache |
Migraña y cefalea por abuso de medicamentos |
|
E.1.1.1 | Medical condition in easily understood language |
Migraine and medication overuse headache |
Migraña y cefalea por abuso de medicamentos |
|
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 | PT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10072720 |
E.1.2 | Term | Medication overuse headache |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
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 |
Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications. Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH |
La cefalea por uso excesivo de medicamentos (CAM) es un tipo de dolor de cabeza causado por el uso excesivo de medicamentos para el dolor de cabeza o para la migraña de manera aguda (medicamentos que se usan para tratar el dolor de cabeza o la migraña una vez que comienza). El tratamiento de la CAM generalmente implica reducir la dosis o suspender los medicamentos que se toman de manera aguda. Eptinezumab es un medicamento utilizado para el tratamiento preventivo de la migraña en adultos. Los principales objetivos de este ensayo son evaluar si eptinezumab ayuda a reducir el número de días con migraña, el número de días con cefalea, y el uso de medicación de manera aguda en adultos que tengan migraña y CAM. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of eptinezumab as add-on to BI on health related quality of life and work productivity - To evaluate the efficacy of eptinezumab during the 12-week open-label extension period |
-Evaluar la eficacia de eptinezumab como complemento de una IB en la calidad de vida relacionada con la salud y la productividad laboral -Evaluar la eficacia de eptinezumab durante el período de extensión abierto de 12 semanas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit. - The participant has 8 migraine days per month for each month within the past 3 months prior to the Screening Visit. - The participant has 15 headache days per month for each month within the past 3 months prior to the Screening Visit. - The participant has had an onset of migraine diagnosis at ≤50 years of age. |
-El participante tiene un diagnóstico de Migraña o CAM, definida según las directrices ICHD-3 de la IHS, confirmado en la visita de selección. -El participante tiene 8 días de migraña al mes en cada uno de los 3 meses previos a la visita de selección. -El participante tiene 15 días de cefalea al mes en cada uno de los 3 meses previos a la visita de selección. -El participante ha recibido el diagnóstico de migraña con una edad ≤50 años. |
|
E.4 | Principal exclusion criteria |
- The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome). - The participant has a diagnosis of acute or active temporomandibular disorders. - The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). - The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit. - The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). |
-El participante tiene un síndrome doloroso que causa confusión y es clínicamente significativo (por ejemplo, fibromialgia, lumbalgia crónica o síndrome de dolor regional complejo). -El participante tiene un diagnóstico de trastorno temporomandibular agudo o activo. -El participante tiene antecedentes o diagnóstico de cefalea tensional crónica, cefalea hípnica, cefalea en brotes, hemicránea continua, cefalea nueva diaria y persistente o subtipos inusuales de migraña, como migraña hemipléjica (esporádica y familiar), neuropatía oftalmopléjica dolorosa recurrente, migraña con aura troncoencefálica y migraña con acompañamientos neurológicos que no son típicos del aura migrañosa (diplopía, alteración de la conciencia o duración prolongada). -El participante presenta psicosis, manía bipolar, demencia o cualquier otro trastorno psiquiátrico cuyos síntomas no están controlados o que no han sido tratados adecuadamente durante un mínimo de 6 meses antes de la visita de selección. -El participante tiene antecedentes de enfermedad cardiovascular clínicamente significativa, como hipertensión no controlada, isquemia vascular o episodios tromboembólicos (por ejemplo, accidente cerebrovascular, trombosis venosa profunda o embolia pulmonar). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in the number of Monthly Migraine Days (MMDs) |
Variación del número de días al mes con migraña (DMM) con respecto al momento basal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline to Weeks 1-4 |
Basal a Semanas 1-4 |
|
E.5.2 | Secondary end point(s) |
1 Change from baseline in MMDs 2 Change from baseline in the number of Monthly Headache Days (MHDs) 3 Change From Baseline in Average Daily Pain Assessment Score 4 Change From Baseline in Monthly Days with Acute Medication Use 5 Percentage of Participants Not Fulfilling the lnternational Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM) 6 Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH 7 Change From Baseline in MMDs with Acute Medication Use 8 Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics) 9 Percentage of Participants with Migraine on the Day After Dosing 10 Response: ≥50% Reduction From Baseline in MMDs 11 Response: ≥75% Reduction From Baseline in MMDs 12 Response: ≥50% Reduction From Baseline in MHDs 13 Response: ≥75% Reduction From Baseline in MHDs 14 Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity 15 Patient Global Impression of Change (PGIC) Score 16 Change in Most Bothersome Symptom (MBS) Score 17 Change From Baseline in the Headache Impact Test (HIT-6) Total score 18 Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score 19 Change From Baseline in the Migraine-Specific Quality of Life (MSQv2.1) Sub-Scores 20 Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score 21 Change From Baseline in Health Care Resources Utilisation (HCRU) Score 22 Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores 23 Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores 24 Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score |
1.Variación de los DMM con respecto al momento basal 2.Variación del número de días al mes con cefalea (DMC) con respecto al momento basal 3.Variación de la puntuación media de evaluación del dolor diario con respecto al momento basal 4.Variación de los días mensuales con uso de medicación para el tratamiento agudo con respecto al momento basal 5.Porcentaje de participantes que no cumplen los criterios diagnósticos ICHD-3 de MC 6.Porcentaje de participantes que no cumplen los criterios diagnósticos ICHD-3 de CAM 7.Variación de los DMM para el tratamiento agudo con respecto al momento basal 8.Variación de los días mensuales con uso de medicación (triptanes, ergotamina, no opiáceos, opiáceos y combinación de analgésicos) con respecto al momento basal 9.Porcentaje de participantes con migraña el día después de la administración. 10.Respuesta: Reducción ≥50% con respecto al momento basal de los DMM 11.Respuesta: Reducción ≥75% con respecto al momento basal de los DMM 12.Respuesta: Reducción ≥50% con respecto al momento basal de los DMC 13.Respuesta: Reducción ≥75% con respecto al momento basal de los DMC 14.Variación de la tasa de migrañas y cefaleas con dolor intenso con respecto al momento basal 15.Puntuación PGIC (Patient Global Impression of Change) 16.Variación en la puntuación MBS (Most Bothersome Symptom) 17.Variación de la puntuación HIT-6 (Headache Impact Test)total desde el momento basal 18.Variación de la puntuación mMIDAS (Migraine Disability Assessment)total desde el momento basal 19.Variación de las subpuntuaciones MSQ v2.1 (Migraine-Specific Quality of Life) desde el momento basal 20.Variación de la puntuación en la escala analógica visual (EAV) del cuestionario EQ-5D-5L (Health-Related Quality of Life) desde el momento basal 21.Variación en la puntuación de la utilización de los recursos sanitarios (URS) desde el momento basal 22.Variación de las subpuntuaciones en la productividad laboral usando el cuestionario WPAI (Work Productivity and Activity Impairment) desde el momento basal 23.Variación de las puntuaciones en las subescalas de depresión y ansiedad de la escala HADS desde el momento basal 24.Variación de la puntuación TSQM-9 (Treatment Satisfaction Questionnaire for Medicine – 9 items) desde el momento basal |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
-1, 7, 8, 16: Weeks 1-12 and Weeks 13-24 -2, 4, 5, 6: Weeks 1-4, Weeks 1-12 and Weeks 13-24 -3: Weeks 1-2 and Weeks 13-24 -9: On the day after dosing -10, 11, 12, 13: Baseline to Weeks 1-4 and Weeks 1-12 -14: Weeks 1-4 and Weeks 1-12 -15, 17: Week 4, Week 12 and Week 24 -18, 19, 20, 24: Baseline to Week 4, Week 12 and Week 24 -21, 22, 23: Baseline to Week 12 and Week 24 |
- 1, 7, 8, 16: Semanas 1-12 y Semanas 13-24 - 2, 4, 5, 6: Semanas 1-4, Semanas 1-12 y Semanas 13-24 - 3: Semanas 1-2 y Semanas 13-24 - 9: El día después de la dosificación - 10, 11, 12, 13: desde el momento basal a las semanas 1 a 4 y semanas 1 a 12 - 14: Semanas 1-4 y Semanas 1-12 - 15, 17: Semana 4, Semana 12 y Semana 24 - 18, 19, 20, 24: desde el momento basal a la semana 4, semana 12 y semana 24 - 21, 22, 23: desde el momento basal hasta la semana 12 y la semana 24 |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 58 |
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 |
Australia |
United States |
Denmark |
Germany |
Italy |
Norway |
Netherlands |
Spain |
|
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
|
LVLS |
Última visita último 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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |