Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
- Registration Number
- NCT04252742
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 512
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo The 4-month DBTP has 2 phases: * Main DBTP (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment. * Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden. Erenumab Erenumab The 4-month DBTP has 2 phases: * Main double-blind treatment phase (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment. * Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden.
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3 Baseline, Month 1, Month 2, and Month 3 At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity was collected. A negative change from baseline indicates a reduction in mean monthly hours of at least moderate headache pain intensity. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value.
The least squares mean (LSM) estimates of change from baseline in reported headache pain intensity utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Monthly Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) Over Months 1, 2, and 3 Baseline, Month 1, Month 2, and Month 3 The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including on Physical Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the past 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value.
The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.Change From Baseline in Mean Monthly Usual Activities Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 Baseline, Month 1, Month 2, and Month 3 The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Usual Activities (10 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value.
The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.Change From Baseline in Mean Monthly Emotional Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 Baseline, Month 1, Month 2, and Month 3 The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Emotional Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value.
The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.Change From Baseline in Mean Monthly Social Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 Baseline, Month 1, Month 2, and Month 3 The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Social Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value.
The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.Change From Baseline in Mean Monthly Average Duration of at Least Moderate Headache Pain Intensity in Migraine Attacks Occurring Over Months 1, 2, and 3 Baseline, Month 1, Month 2, and Month 3 At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity during a migraine attack was collected. A negative change from baseline indicates a reduction in mean monthly average duration of at least moderate headache pain intensity during a migraine attack. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value.
The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.Change From Baseline in Mean Monthly Average Peak Migraine Pain Intensity as Assessed by the 11-point Numeric Rating Scale (NRS) Over Months 1, 2, and 3 Baseline, Month 1, Month 2, and Month 3 The NRS assesses headache pain intensity ranging from 0 to 10 with a higher score indicating more severe pain. Participants recorded the pain intensity using the e-diary at the headache end-time or in an evening diary entry on a daily basis for an ongoing headache. A negative change from baseline indicates an improvement in pain intensity. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value.
The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
Trial Locations
- Locations (88)
Chicago Headache Center and Research Institute
🇺🇸Chicago, Illinois, United States
Clinical Research Institute, LLC
🇺🇸Los Angeles, California, United States
Poliklinika Chocen, Neurohk sro
🇨🇿Chocen, Czechia
NeuroMed Zlin sro
🇨🇿Zlin, Czechia
Summit Research Network
🇺🇸Portland, Oregon, United States
Azienda Socio Sanitaria Teritoriale Spedali Civili di Brescia
🇮🇹Brescia, Italy
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
🇭🇺Budapest, Hungary
Dado Medical sro
🇨🇿Praha 2, Czechia
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
Palmetto Clinical Trial Services
🇺🇸Greenville, South Carolina, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ospedale Policlinico San Martino IRCCS
🇮🇹Genoa, Italy
North Texas Institute of Neurology and Headache
🇺🇸Frisco, Texas, United States
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
🇧🇬Plovdiv, Bulgaria
Obudai Egeszsegugyi Centrum Kft
🇭🇺Zalaegerszeg, Hungary
Ospedale Bellaria Carlo Alberto Pizzardi
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco
🇮🇹Catanzaro, Italy
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Neurologie Brno sro
🇨🇿Brno, Czechia
Papillion Research Center
🇺🇸Papillion, Nebraska, United States
FORBELI sro
🇨🇿Praha 6, Czechia
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Italy
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Brain-soultherapy sro
🇨🇿Kladno, Czechia
Fakultni nemocnice u svate Anny v Brne
🇨🇿Brno, Czechia
Institut Neuropsychiatricke pece
🇨🇿Praha, Czechia
Spitalul Clinic Judetean de Urgenta Pius Brinzeu Timisoara
🇷🇴Timisoara, Romania
Hospital da Luz, SA
🇵🇹Lisboa, Portugal
Multiprofile Hospital for Active Treatment in neurology and psychiatry Sveti Naum EAD
🇧🇬Sofia, Bulgaria
Medical Center Excelsior OOD
🇧🇬Sofia, Bulgaria
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
🇮🇹Pavia, Italy
Azienda della scienza di Torino
🇮🇹Torino, Italy
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Italy
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
Long Beach Clinical Trials Services Inc
🇺🇸Long Beach, California, United States
Mountain Neurological Research Center
🇺🇸Basalt, Colorado, United States
Denver Neurological Clinic
🇺🇸Denver, Colorado, United States
Summit Headache and Neurologic Institute
🇺🇸Englewood, Colorado, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Visionary Investigators Network
🇺🇸Pembroke Pines, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Saint Lukes Clinic
🇺🇸Meridian, Idaho, United States
Heuer Medical Doctor Research LLC
🇺🇸Orlando, Florida, United States
Neurology Associates of Ormond Beach
🇺🇸Ormond Beach, Florida, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
New England Regional Headache Center Inc
🇺🇸Worcester, Massachusetts, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Mercy Health Research
🇺🇸Saint Louis, Missouri, United States
American Clinical Research Institute LLC
🇺🇸Beavercreek, Ohio, United States
Medical Center New Rehabilitation Center EOOD
🇧🇬Stara Zagora, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska EAD
🇧🇬Sofia, Bulgaria
IRCCS San Raffaele Pisana
🇮🇹Roma, Italy
Centrum Badan Klinicznych PI-House Spzoo
🇵🇱Gdansk, Poland
Gabinet Diagnostyki i Leczenia Osteoporozy Prof Wojciech Pluskiewicz
🇵🇱Gliwice, Poland
Care Clinic Spzoo Care Clinic Centrum Medyczne
🇵🇱Katowice, Poland
Vita Longa Spzoo
🇵🇱Katowice, Poland
NZOZ Neuromed M i M Nastaj Spolka Partnerska
🇵🇱Lublin, Poland
AppleTreeClinics Network Spzoo
🇵🇱Lodz, Poland
Instytut Zdrowia Dr Boczarska-Jedynak Spzoo SpKom
🇵🇱Oswiecim, Poland
Prywatny Gabinet Neurologiczny Iwona Rosciszewska-Zukowska
🇵🇱Rzeszow, Poland
Hospital Cuf Sintra
🇵🇹Sintra, Portugal
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
🇵🇱Wroclaw, Poland
Campus Neurologico Senior
🇵🇹Torres Vedras, Portugal
Vistamed and Vertigo Sp z o o
🇵🇱Wroclaw, Poland
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
🇷🇴Bucuresti, Romania
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Andalucía, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Aragón, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Castilla León, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD
🇧🇬Pleven, Bulgaria
University First Multiprofile Hospital for Active Treatment - Sofia Sveti Yoan Krastitel EAD
🇧🇬Sofia, Bulgaria
Uno Medical Trials Kft
🇭🇺Budapest, Hungary
Spitalul Universitar de Urgenta Bucuresti
🇷🇴Bucuresti, Romania
High Tech Medical Kft
🇭🇺Budapest, Hungary
S-Medicon Kutatasi Centrum
🇭🇺Budapest, Hungary
M-Zdrowie
🇵🇱Lodz, Poland
Osrodek Badan Klinicznych Cromed
🇵🇱Poznan, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Nashville Neuroscience Group
🇺🇸Nashville, Tennessee, United States
Forte Family Practice
🇺🇸Las Vegas, Nevada, United States