Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
18 de septiembre de 2018 actualizado por: Merck Sharp & Dohme LLC
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura
The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura.
Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1935
Fase
- Fase 3
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- History of migraines within the past year
- 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
- Use acceptable contraception throughout the study
- Able to complete the study questionnaire(s) and paper diary
- Limit consumption of grapefruit juice to no more than one 8 ounce glass a day
Exclusion Criteria:
- Pregnant or breast-feeding or is expecting to become pregnant during the study
- Difficulty distinguishing his/her migraine attacks from tension or interval headaches
- A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
- More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
- Greater than 50 years old at the age of migraine onset
- Previously taken telcagepant
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Telcagepant 140 mg
Telcagepant 140 mg, oral, tablet, across 4 migraine attacks.
For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
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Telcagepant 140 mg tablets
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Experimental: Telcagepant 280 mg
Telcagepant 280 mg, oral, tablet, across 4 migraine attacks.
For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
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Telcagepant 280 mg tablets
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Comparador de placebos: Control Group 1
Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th).
Telcagepant 140 mg will be administered for the 3rd migraine attack.
Participants will receive placebo for the optional second dose.
For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
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Telcagepant 140 mg tablets
Tabletas de placebo
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Comparador de placebos: Control Group 2
Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd).
Telcagepant 140 mg will be administered for the 4th migraine attack.
Participants will receive placebo for the optional second dose.
For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
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Telcagepant 140 mg tablets
Tabletas de placebo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: 2 hours post-dose for the first migraine attack (up to 6 months)
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Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose.
Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
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2 hours post-dose for the first migraine attack (up to 6 months)
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Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: 2 hours post-dose for the first migraine attack (up to 6 months)
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Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose.
Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
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2 hours post-dose for the first migraine attack (up to 6 months)
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Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose
Periodo de tiempo: 2 hours post-dose (up to 6 months)
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Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks.
Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.
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2 hours post-dose (up to 6 months)
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Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose
Periodo de tiempo: 2 hours post-dose (up to 6 months)
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Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks.
Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.
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2 hours post-dose (up to 6 months)
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Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: 2 hours post-dose for the first migraine attack (up to 6 months)
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The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
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2 hours post-dose for the first migraine attack (up to 6 months)
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Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: 2 hours post-dose for the first migraine attack (up to 6 months)
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The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
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2 hours post-dose for the first migraine attack (up to 6 months)
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Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: 2 hours post-dose for the first migraine attack (up to 6 months)
|
The participant recorded whether nausea was present or absent at each of the predefined time points.
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2 hours post-dose for the first migraine attack (up to 6 months)
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Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: Up to 48 hours post-dose for the first migraine attack (up to 6 months)
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AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window.
AEs displayed are those reported by at least 4 participants in one or more treatment groups.
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Up to 48 hours post-dose for the first migraine attack (up to 6 months)
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Number of Participants Discontinuing Study Medication Due to an AE
Periodo de tiempo: Up to the 4th dose of study medication (up to 6 months)
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Participants discontinuing study medication due to an AE were reported for all migraine attacks.
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Up to the 4th dose of study medication (up to 6 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
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Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration.
SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.
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From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
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Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
|
Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration.
SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication.
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From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)
|
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Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: 2 hours post-dose for the first migraine attack (up to 6 months)
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TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.
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2 hours post-dose for the first migraine attack (up to 6 months)
|
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Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)
Periodo de tiempo: From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
|
TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.
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From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de agosto de 2008
Finalización primaria (Actual)
25 de marzo de 2009
Finalización del estudio (Actual)
25 de marzo de 2009
Fechas de registro del estudio
Enviado por primera vez
15 de mayo de 2007
Primero enviado que cumplió con los criterios de control de calidad
6 de junio de 2007
Publicado por primera vez (Estimar)
7 de junio de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0974-031
- MK-0974-031 (Otro identificador: Merck Protocol Number)
- 2007_546 (Otro identificador: Telerx ID Number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Datos del estudio/Documentos
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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