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NCT04825678 Clinical Trial

A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine

Migraine Clinical Trial

Official title:
Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04825678
Other study ID # 20190389
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 11, 2021
Est. completion date September 28, 2023

Study information
Verified date October 2023
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date September 28, 2023
Est. primary completion date September 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Erenumab
Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).

Locations
Country Name City State
United States Albany Medical College Albany New York
United States Albuquerque Clinical Trials Inc Albuquerque New Mexico
United States Dent Neurosciences Research Center Amherst New York
United States Asheville Neurology Specialists PA Asheville North Carolina
United States Mountain Neurological Research Center Basalt Colorado
United States Saint Lukes Neurology Associates Bethlehem Pennsylvania
United States Citizens Memorial Healthcare Bolivar Missouri
United States Montefiore Medical Center Bronx New York
United States Clinical Trials of South Carolina Charleston South Carolina
United States Onsite Clinical Solutions LLC Charlotte North Carolina
United States Chicago Headache Center and Research Institute Chicago Illinois
United States Vaught Neurological Services Crab Orchard West Virginia
United States Neurology Center of New England Foxboro Massachusetts
United States Neurology Center of North Orange County Fullerton California
United States Family HealthCare Germantown Maryland
United States Northwell Health Physician Partners Neuroscience Institute at Great Neck Great Neck New York
United States Premier Neurology Greer South Carolina
United States Reliable Clinical Research, LLC Hialeah Florida
United States Homestead Associates In Research Inc Homestead Florida
United States Pearland Neurology Services PLLC Houston Texas
United States Rehabilitation and Neurological Services LLC Huntsville Alabama
United States Protenium Clinical Research Hurst Texas
United States Tri-State Mountain Neurology Associates Johnson City Tennessee
United States ActivMed Practices and Research, LLC Lowell Massachusetts
United States Georgia Institute for Clinical Research, LLC Marietta Georgia
United States New Age Medical Research Corporation Miami Florida
United States The Community Research of South Florida Miami Lakes Florida
United States Mindscapes Counseling, LLC Norwich Connecticut
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States Research Institute of Orlando Orlando Florida
United States College Park Family Care Center Overland Park Kansas
United States Memorial Healthcare Foundation Owosso Michigan
United States Elite Clinical Studies LLC Phoenix Arizona
United States Island Neurological Associates Plainview New York
United States SRI International Plymouth Michigan
United States The Neurology Group Pomona California
United States Nuvance Health Medical Practice Primary Care Division of Neurology Poughkeepsie New York
United States Psych Care Consultants Saint Louis Missouri
United States Clinvest Research LLC Springfield Missouri
United States Houston Neurology Associates Sugar Land Texas
United States Sugar Lakes Family Practice Sugar Land Texas
United States Pas Research Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 As measured by items 12 to 14 of the TSQM version 1.4. Items 12 and 13 measure confidence in benefits and balance between good and bad things on a 5 point rating scale where 1 indicates least satisfaction and 5 indicates most satisfaction. Item 14 measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction. Baseline and Week 24
Secondary Number of Participants Achieving Overall Satisfaction at Week 24 Overall satisfaction is defined by participant reporting of satisfied, very satisfied, or extremely satisfied on item 14 of the TSQM version 1.4. Item 14 of the TSQM measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction. Week 24
Secondary Number of Participants Reporting Improvement in Participant Global Impression at Week 24 Improvement is defined by participant reporting of much improved or a little improved on the migraine Global Impression Item (mGI-I). Week 24
Secondary Number of Clinician's Reporting Improvement in Treating Clinician's Global Impression at Week 24 Improvement is defined by treating clinician's reporting of much improved or a little improved on the mGI-I for each individual participant. Week 24
Secondary Number of Key Family Member's Reporting Improvement in Key Family Member's Impression at Week 24 Improvement is defined by key family member's reporting of much improved or a little improved on the mGI-I for each individual participant. Week 24
Secondary Mean Change from Baseline in Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 Baseline and Week 24
Secondary Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24 Baseline and Week 24
Secondary Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24 Baseline and Week 24
Secondary Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24 Baseline and Week 24
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