Phase 4
N=240
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT04825678 ↗Enrolled (actual)
240
Serious AEs
2.5%
Results posted
Sep 2024
Primary outcome: Primary: Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC — 42.33; 34.42 Score on a scale — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Erenumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC |
42.33; 34.42 | < 0.001 sig |
| PRIMARY Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type |
34.76; 43.44 | < 0.001 sig |
| SECONDARY Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC |
91.0; 66.7 | — |
| SECONDARY GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC |
91.8; NA | — |
| SECONDARY Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type |
75.6; 92.6 | — |
| SECONDARY GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type |
76.2; 93.2 | — |
| SECONDARY Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC |
94.0; 83.3; 93.7; 84.6; 92.8; 100.0 | — |
| SECONDARY GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC |
94.6; NA; 90.9; NA; 92.6; NA | — |
| SECONDARY Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type |
83.9; 95.5; 87.5; 94.4; 85.7; 94.5 | — |
| SECONDARY GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type |
NA; 95.5; 87.3; 94.5; NA; NA | — |
| SECONDARY Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC |
-46.29; -49.04; -44.83; -45.00; -45.87; -46.15 | < 0.001 sig |
| SECONDARY Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type |
-29.84; -50.42; -32.22; -47.84; -32.99; -48.95 | < 0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT04825678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.