A Functional MRI Study on Erenumab Treatment Effects in Episodic Migraine Patients

A RandomizEd, Double-blind, Cross-over Study to Assess Erenumab effecT on BRAIN Networks Function and Structure in Comparison to Placebo in Episodic Migraine Patients

ClinicalTrials.gov Identifier: NCT03977649

Novartis Reference Number: CAMG334AIT03

Last Update: Nov 10, 2020

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this study is to investigate the effects of erenumab on central sensitization and brain networks connectivity of migraine patients

Condition

Migraine Disorders

Phase

Phase 4

Overall status

Recruiting

Enrollment count

120 participants

Start date

Jul 30, 2019

Completion date

May 28, 2021

Gender

All

Age(s)

18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug

erenumab

erenumab 140 mg sc every 4 weeks

Drug

placebo

placebo sc every 4 weeks

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study History of migraine with or without aura for at least 12 months prior to screening 4. Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening and confirmed during the baseline phase based on diary calculation
Headache frequency: <15 headache days per month on average across the 3 months prior to screening and confirmed during the baseline phase based on diary calculation
Failure to 2 or more previous treatment categories locally indicated for migraine prophylaxis due to either lack of efficacy or poor tolerability

Exclusion Criteria:

History of cluster headache or hemiplegic migraine headache
History of chronic pain disorders and neuropathic pain
History of head trauma or seizure or major psychiatric disorders or suicidal ideation/behavior at any time before screening
Currently, receiving any other prophylactic treatment for migraine and/or prohibited medications, non-pharmacologic interventions or devices (any substance, non-pharmacologic intervention or device acting at central nervous system), or less than 60 days or 5 half-lives prior to the start of the baseline period, during the baseline period, or treatment period
Exposure to botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline period, during the baseline period, or treatment period.

Taken the following for any indication in any month during the 2 months prior to the start of the baseline period:

Ergotamines or triptans on ≥ 10 days per month, or
Simple analgesics (non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on ≥ 15 days per month, or
Opioid- or butalbital-containing analgesics on ≥4 days per month.
Previous exposure to erenumab or exposure to any other prophylactic CGRP-targeted therapy (prior to and during the study)
History or evidence of any other 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
Subject has any clinically significant vital sign, laboratory, or electrocardiogram (ECG) abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records or patient self-report
Pregnant or breastfeeding
All the clinical conditions for which undergoing an MRI scan is contraindicated