Clinical trial NCT04825678: A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
Official title: Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Chronic Migraine
Episodic Migraine
Erenumab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Participant has provided informed consent
* History of migraine (with or without aura) for ≥ 12 months before screening
* ≥ 4 migraine days per month on average across the 3 months prior to screening
* Treatment with 1 oral migraine preventive medication and/or concomitant use of OnabotulinumtoxinA injections for migraine prevention.
* Participant reports to their provider intolerance or insufficient response with their current preventative treatment

Exclusion Criteria:

* History of cluster headache or hemiplegic migraine headache
* Unable to differentiate migraine from other headaches
* Evidence of substance-related disorders
* Active chronic pain syndromes (eg, fibromyalgia and chronic pelvic pain)
* No therapeutic response with \> 3 migraine preventive medication categories
* Used a prohibited medication, device, or procedure
* Other clinically significant disorder, condition, or disease

Primary outcomes:
measure: Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
timeFrame: Week 24
measure: GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
timeFrame: Baseline up to Week 24
measure: Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
timeFrame: Week 24
measure: GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
timeFrame: Baseline up to Week 24
measure: Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC
timeFrame: Baseline and Week 24
measure: GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC
timeFrame: Baseline up to Week 24
measure: Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
timeFrame: Baseline and Week 24
measure: GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
timeFrame: Baseline up to Week 24
measure: Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC
timeFrame: Baseline and Week 24
measure: Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rehabilitation and Neurological Services LLC
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies LLC
state: Arizona
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Pomona
country: United States
facility: The Neurology Group
state: California
city: Basalt
country: United States
facility: Mountain Neurological Research Center
state: Colorado
city: Norwich
country: United States
facility: Mindscapes Counseling, LLC
state: Connecticut
city: Hialeah
country: United States
facility: Reliable Clinical Research, LLC
state: Florida
city: Homestead
country: United States
facility: Homestead Associates In Research Inc
state: Florida
city: Miami Lakes
country: United States
facility: The Community Research of South Florida
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: Orlando
country: United States
facility: Research Institute of Orlando
state: Florida
city: Tampa
country: United States
facility: Pas Research
state: Florida
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Chicago
country: United States
facility: Chicago Headache Center and Research Institute
state: Illinois
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Germantown
country: United States
facility: Family HealthCare
state: Maryland
city: Foxboro
country: United States
facility: Neurology Center of New England
state: Massachusetts
city: Lowell
country: United States
facility: ActivMed Practices and Research, LLC
state: Massachusetts
city: Owosso
country: United States
facility: Memorial Healthcare Foundation
state: Michigan
city: Plymouth
country: United States
facility: SRI International
state: Michigan
city: Bolivar
country: United States
facility: Citizens Memorial Healthcare
state: Missouri
city: Saint Louis
country: United States
facility: Psych Care Consultants
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials Inc
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Great Neck
country: United States
facility: Northwell Health Physician Partners Neuroscience Institute at Great Neck
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates
state: New York
city: Poughkeepsie
country: United States
facility: Nuvance Health Medical Practice Primary Care Division of Neurology
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists PA
state: North Carolina
city: Charlotte
country: United States
facility: Onsite Clinical Solutions LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Bethlehem
country: United States
facility: Saint Lukes Neurology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Greer
country: United States
facility: Premier Neurology
state: South Carolina
city: Johnson City
country: United States
facility: Tri-State Mountain Neurology Associates
state: Tennessee
city: Houston
country: United States
facility: Pearland Neurology Services PLLC
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Houston Neurology Associates
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice
state: Texas
city: Crab Orchard
country: United States
facility: Vaught Neurological Services
state: West Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: