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Imaging the Migraine Brain Pre- and Post-Erenumab | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Imaging the Migraine Brain Pre- and Post-Erenumab

Imaging the Migraine Brain Pre- and Post-Erenumab: an MRI Study to Identify Functional and Structural Changes That Correlate With Patient Improvement

NCT03773562•Mayo Clinic

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+14 more criteria

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Key Dates

Start Date

March 25, 2019

Primary Completion Date

June 30, 2022

Completion Date

June 30, 2022

Last Updated

January 9, 2024

Enrollment

ACTUAL participants

Conditions

Migraine

Interventions

Erenumab

DRUG

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

NCT06641466

Menstrual Migraine

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RECRUITINGPHASE3

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713

Chronic Migraine

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Imaging the Migraine Brain Pre- and Post-Erenumab

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.