Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE) - INTERROGATE

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1406

Inclusion Criteria

Before baseline period
101 Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
102 Age = 18 years upon entry into screening.
103 History of migraine (with or without aura) for = 12 months before screening according to the International Headache Society (IHS) Classification ICDH-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report
104 = 4 headache days that meet criteria as migraine day per month on average across the 3 months before screening

After baseline period
105 Must have demonstrated = 75% compliance in eDiary usage during baseline period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

201 > 50 years of age at migraine onset
202 History of cluster headache or hemiplegic migraine headache
203 Inability to differentiate between migraine from other headaches
204 The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
205 History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
206 Previously received erenumab (Aimovig)
207 Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period
208 Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
209 Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
210 Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product.
211 Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product.
212 Evidence of current pregnancy or breastfeeding per subject self-report or medical record
213 Subject has known sensitivity to any of the products or components to be administered during dosing.
241 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the relationship between clinical response to erenumab and genetic biomarkers.;Secondary Objective: ;Primary end point(s): Achievement of at least a 50% reduction from baseline in mean monthly migraine days (MMD) over months 4, 5 and 6 in relation to each individual genome-wide significant single-nucleotide polymorphism (SNP) contributing to the migraine polygenic risk score (mPRS).;Timepoint(s) of evaluation of this end point: Months 4, 5, 6

Secondary Outcome Measures