High frequency episodic migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Aimovig
Product Name: AMG 334 PFS
Product Code: AMG 334
Pharmaceutical Form: Solution for infusion in pre-filled syringe
CAS Number: 1582205-90-0
Current Sponsor code: AMG 334
Concentratio
Sponsors
Amgen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria include: • Age = 18 years upon entry into initial screening • Documented history of migraine with or without aura according to the International Headache Society (IHS) International Classification of Headache Disorders, Third Edition (ICHD-III) for = 12 months • Have HFEM: Defined as history of = 7 to 50% of attacks of at least moderate pain intensity. Regular use is defined as = 4 days of oral triptan use per month during the 3 months prior to screening. 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 386 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 190
Exclusion criteria
Exclusion criteria: Key exclusion criteria include: • History of hemiplegic migraine, cluster headache, or other trigeminal autonomic cephalalgia • Has any medical contraindication to the use of an oral triptan • Previously treated with erenumab • Previously treated with a gepant (small molecule calcitonin gene related peptide receptor [CGRP-R] antagonist) in a preventive fashion • Previously treated with a ligand-based anti-CGRP monoclonal antibody (ie, fremanezumab, galcanezumab and/or eptinezumab) in a manner consistent with migraine prevention that either: (a) in the opinion of the investigator, did not offer any evidence of a therapeutic response OR (b) was discontinued for less than 12 weeks from the date of initial screening OR (c) was previously discontinued due to a known adverse drug reaction • Currently being treated with lasmiditan and/or a gepant in the acute setting • No therapeutic response with > 4 of the defined medication categories after an adequate therapeutic trial • Currently has a history of consistent excellent response to oral triptans, defined as achievement of pain-freedom in = 1 hour for = 50% of treated attacks of at least moderate pain intensity during the 3 months prior to screening • Use of triptans administered via a non-oral (eg, subcutaneous [SC] or intranasal delivery systems) or sublingual route at the time of screening, during the run-in and baseline periods, and throughout the study duration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.;Secondary Objective: ;Primary end point(s): Change from baseline in mean monthly hours of at least moderate headache pain intensity over months 1, 2, and 3;Timepoint(s) of evaluation of this end point: Months 1, 2, and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in mean monthly function domain score as measured by the Migraine Functional Impact Questionnaire (MFIQ) over months 1, 2, and 3: - Impact on physical functioning - Impact on usual activities - Impact on emotional functioning - Impact on social functioning - Change from baseline in mean monthly average duration of at least moderate pain intensity in migraine attacks occuring over months 1, 2, and 3 (migraine attacks as defined in Section 11.1) - Change from baseline in mean monthly average peak migraine pain intensity as assessed by the 11-point Numeric Rating Scale (NRS) over months 1, 2, and 3;Timepoint(s) of evaluation of this end point: Months 1, 2, and 3 | — |
Countries
Bulgaria, Czech Republic, Hungary, Italy, Poland, Portugal, Romania, United States
Contacts
Public ContactMedical department
Amgen Bulgaria EOOD
Outcome results
None listed