Episodic or chronic migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: AMG 334
Product Code: AMG 334
Pharmaceutical Form: Solution for injection in pre-filled pen
CAS Number: 1582205-90-0
Current Sponsor code: AMG 334
Other descriptive name: AMG 334
Concent
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 1400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. 214 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. 215 Initiation, discontinuation, or change of dosing of migraine prophylactic medications within 2 months prior to the start of the baseline period, during the baseline period or planned during the study. Refer to Section 6.1.7 or additional information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Months 4, 5, 6;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). | — |
Countries
Denmark, Iceland
Contacts
Public ContactMedical Info - Clinical Trials
Amgen AB
Outcome results
None listed