a functional mri study on erenumab treatment effects in episodic migraine patients

Conditions: Migraine Disorders

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

this is a randomized, double blind, placebo-controlled trial with a 2-sequence, 2-period, 2-treatment crossover design. the study population will consist of adult male and female subjects with a documented history of episodic migraine (4 to 14 baseline migraine days), who have failed at least 2 previous migraine prophylactic treatment for lack of efficacy or tolerability. after a run-in phase of 4 weeks, patients will be randomized, according to a 1:1 ratio, to a 24 weeks of treatment, as follow: * sequence 1: a/b * sequence 2: b/a where: a=monthly subcutaneous erenumab 140 mg for 12 weeks; b=monthly subcutaneous masked placebo for 12 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

Keywords: amg334 erenumab functional mri connectivity