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

• Status: Recruiting
• Trial end date: 2023-04-23
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Erenumab

Criteria

Key inclusion criteria include:

• Age greater than or equal to 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 greater than or equal to 12 months.

• 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.

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.

• No therapeutic response with greater than 4 of the defined medication categories after an adequate therapeutic trial.

• Use of triptans administered via a non-oral (e.g. 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.