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-PT
• Lead Sponsor: Amgen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-24
• Last Update Posted: 8 April 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 and < 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 user of an oral triptan (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 any agent (monoclonal antibody or small molecule) targeting the calcitonin gene-related peptide (CGRP) pathway (ligand or receptor) in the preventive setting
¿ Previously treated or currently being treated with lasmiditan 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.;Secondary Objective: To evaluate the treatment benefit of erenumab on functional impairment. <br>To evaluate the treatment benefit of erenumab on duration of migraine pain of at least moderate intensity.<br>To evaluate the treatment benefit of erenumab on peak migraine pain intensity.;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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Change from baseline in mean monthly function as measured by the Migraine Functional Impact Questionnaire (MFIQ) over months 1, 2, and 3:<br>¿ Impact on physical functioning<br>¿ Impact on usual activities<br>¿ Impact on emotional functioning<br>¿ Impact on social functioning<br><br>- Change from baseline in mean monthly hours of at least moderate pain intensity per migraine attack over months 1, 2, and 3<br><br>- Change from baseline in mean monthly 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