Phase 4
N=50
Imaging the Migraine Brain Pre- and Post-Erenumab
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03773562 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Resting State Functional Connectivity — 26.2; 23.3 global efficiency percentage — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Erenumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting State Functional Connectivity |
26.2; 23.3 | 0.04 sig |
| SECONDARY Erenumab Responders |
18 | — |
| SECONDARY Iron Accumulation in Periaqueductal Gray Brain Region |
43.0; 32.5 | 0.002 sig |
| SECONDARY Iron Accumulation in Anterior Cingulate Cortex Brain Region |
50; 40 | 0.01 sig |
| SECONDARY Change in the Migraine Disability Assessment Questionnaire (MIDAS) |
-16.5; 5.8 | — |
| SECONDARY ROI-ROI Functional Connectivity of Middle Temporal Left With Supramarginal Gyrus Right Regions of the Brain |
0.34; 0.02 | 0.0003 sig |
| SECONDARY ROI-ROI Functional Connectivity of Temporal Pole Right With Middle Occipital Right |
0.24; -0.08 | 0.0003 sig |
| SECONDARY ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Middle Frontal Left |
-0.07; 0.24 | 0.0003 sig |
| SECONDARY ROI-ROI Functional Connectivity of Dorsolateral Prefrontal Cortex Left With Hypothalamus Right |
0.02; -0.18 | 0.0033 sig |
| SECONDARY ROI-ROI Functional Connectivity of Inferior Lateral Parietal Right With Supramarginal Gyrus Right |
0.68; 0.38 | 0.0041 sig |
| SECONDARY ROI-ROI Functional Connectivity of Ventromedial Prefrontal Cortex Left With Pulvinar Right |
0.18; -0.07 | 0.0046 sig |
Summary
Researchers are trying to determine if there is a difference between brain images of subjects that do respond to treatment with erenumab and subjects who do not respond to treatment with erenumab using Magnetic Resonance Imaging (MRI).
Eligibility Criteria
Inclusion Criteria
- 18-65 years of age
- Episodic migraine (with or without aura) or chronic migraine according to the diagnostic criteria included within the International Classification of Headache Disorders 3 (ICHD-3)
- 6-25 migraine days per month on average over the 3 months prior to screening, confirmed by run-in phase prospective data collection
- Duration since migraine onset of at least 12 months prior to screening based on medical records and/or patient self-report
Exclusion Criteria
- Older than 50 years of age at migraine onset
- History of cluster headache or hemiplegic migraine
- Continuous headache pain (i.e. no pain-free periods of any duration during the one month before screening)
- Opioid- or butalbital-containing analgesics on 6 or more days per month during the 2 months prior to the start of the baseline phase
- History of major psychiatric disorder such as schizophrenia and bipolar disorder
- History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- No therapeutic response in migraine prevention after an adequate therapeutic trial of 4 or more of the following medication categories: Category 1- divalproex sodium, sodium valproate; Category 2- topiramate; Category 3- beta-blockers; Category 4- tricyclic antidepressants; Category 5- venlafaxine or desvenlafaxine, duloxetine or milnacipran; Category 6- flunarizine, verapamil; Category 7- lisinopril, candesartan; Category 8- botulinum toxin. No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally accepted therapeutic dose(s) based on the investigator's assessment. Lack of sustained response to a medication and failure to tolerate a therapeutic dose are not considered to be "no therapeutic response".
- Concomitant use of 3 or more of the following medications for migraine prevention within 2 months before the start of the baseline phase or throughout the study: divalproex sodium, sodium valproate, topiramate, carbamazepine, gabapentin, beta-blockers, tricyclic antidepressants, venlafaxine, desvenlafaxine, duloxetine, milnacipran, flunarizine, verapamil, lomerizine, lisinopril, candesartan, clonidine, guanfacine, cyproheptadine, methysergide, pizotifen, butterbur, feverfew, magnesium (at least 600 mg per day), riboflavin (at least 100 mg per day). Use of up to two medications is permitted as long as the dose has been stable for at least 2 months before the start of the run-in phase and during the study.
- Botulinum toxin (in the head and/or neck region) within 4 months before the start of the baseline phase and throughout the study
- Ergotamine derivatives, steroids, and triptans used for migraine prophylaxis within 2 months before the start of the baseline phase and throughout the study
- Procedures (e.g. nerve blocks) used for migraine prophylaxis within 2 months before the start of the baseline phase and throughout the study
- History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening.
- Contraindications to MRI including, but not limited to: Metal implants, aneurysm clips, severe claustrophobia, implanted electronic devices, insulin or infusion pump, cochlear/otologic/ear implant, non-removable prosthesis, implanted shunts/catheters, certain intrauterine devices, tattooed makeup, body piercings that cannot be removed, metal fragments, wire sutures or metal staples.
- Factors that Reduce MR Image Quality and Interpretability: dental braces or other non-removable devices (e.g. retainers); prior brain surgery; known brain MRI abnormality that in the investigator's opinion will significantly impact MRI data
- Sensory disorders that in the investig
Data sourced from ClinicalTrials.gov (NCT03773562). 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.