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Study Complete
Sponsor ID
20190389

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

Sponsor ID
20190389
Clinicaltrials.gov ID
NCT04825678
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 4
Product
Erenumab
Type
Interventional
Masking
None (Open Label)
Enrollment
240
Additional Study Details

Protocol Summary

Primary Outcome Measures

Mean Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24

Timeframe: Baseline and Week 24

Secondary Outcome Measures

Number of Participants Achieving Overall Satisfaction at Week 24

Timeframe: Week 24

Number of Participants Reporting Improvement in Participant Global Impression at Week 24

Timeframe: Week 24

Number of Clinician's Reporting Improvement in Treating Clinician’s Global Impression at Week 24

Timeframe: Week 24

Number of Key Family Member’s Reporting Improvement in Key Family Member's Impression at Week 24

Timeframe: Week 24

Mean Change from Baseline in Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24

Timeframe: Baseline and Week 24

Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24

Timeframe: Baseline and Week 24

Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24

Timeframe: Baseline and Week 24

Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24

Timeframe: Baseline and Week 24

Locations

Location
Status
Contact Us
Location
Vaught Neurological Services
Crab Orchard, WV, United States, 25827
Status
Recruiting
Location
Research Institute of Orlando
Orlando, FL, United States, 32806
Status
Recruiting
Location
Asheville Neurology Specialists PA
Asheville, NC, United States, 28806
Status
Recruiting
Location
Mountain Neurological Research Center
Basalt, CO, United States, 81621
Status
Terminated
Location
Citizens Memorial Healthcare
Bolivar, MO, United States, 65613
Status
Recruiting
Location
Clinical Trials of South Carolina
Charleston, SC, United States, 29406
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Migraine
    • Sex
    All
    Trial Dates
    Jun 2021 - Sep 2023
    Inclusion and Exclusion 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