Erenumab – Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine.

Phase 1

• Conditions: High frequency episodic migraine; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003646-33-CZ
• Lead Sponsor: Amgen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-10
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 576

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 < 15 migraine days and < 15 headache days per month on average during the 3 months prior to screening
• History of = 4 migraine attacks of at least moderate severity per month on average during the 3 months prior to screening
• History of treatment failure with at least 1 preventive treatment for migraine. Failure of preventive treatment for migraine is defined as treatment discontinuation due to lack of efficacy, adverse event, or general poor tolerability.
• Regular use of an oral triptan (using only eletriptan, rizatriptan, sumatriptan, or zolmitriptan) for acute migraine treatment, and typically initiating acute treatment with an oral triptan on > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified