NCT03912337

Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine

Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine Who Have Previously Failed 1 or More Migraine Preventive Treatments.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of erenumab compared to placebo on disability in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.

Detailed description

Migraine prevention continues to be an area of large, unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) has an important role in the pathophysiology of migraine. Erenumab-aooe is a fully human monoclonal antibody that targets the CGRP receptor, and interrupts its downstream effects. Erenumab has been approved for the preventive treatment of migraine in adults. The present study is a Phase IV trial that will assess the effect of erenumab on disability and work productivity in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Placebo	Placebo once every 4 weeks. SC injection.
DRUG	Erenumab	Erenumab once every 4 weeks. SC injection.

Timeline

• Start date: 2019-12-04
• Primary completion: 2021-07-28
• Completion: 2021-07-28
• First posted: 2019-04-11
• Last updated: 2022-07-20
• Results posted: 2022-07-20

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study