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

Amgen

Status and phase: Terminated; Phase 4

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Erenumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03912337

20180060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years of age upon entry into screening.
• Documented history of migraine with or without aura according to the IHS ICHD-III for greater than or equal to 12 months
• Has EM defined as history of greater than or equal to 4 and less than 15 migraine days and less than 15 headache days per month on average during the 3 months prior to initial screening
• Employed greater than or equal to 20 hours/week upon entry into initial screening, stable for at least 3 months in the same job and has not specified willful termination of employment throughout the duration of the study. Employment is defined by work outside the home, self-employed, or works from home
• Has greater than or equal to 4 hours of lost productive time due to headache/migraine and/or related symptoms in the past month prior to initial screening as determined by subject
• Has total disability score of greater than 10 as assessed by MIDAS (3-month recall) at initial screening
• History of treatment failure with at least 1 preventive treatment category for migraine

Exclusion criteria

• Older than 50 years of age at migraine onset
• History of cluster headache, hemiplegic migraine, or other trigeminal autonomic cephalalgia.
• Taken an opioid and/or opioid-containing analgesic greater than or equal to 4 days during the 1 month prior to screening for any indication
• Taken a butalbital and/or butalbital-containing analgesic greater than or equal to 4 days during the 1 month prior to screening for any indication
• Change in the regimen of current migraine preventive treatment or a concomitant medication that may have migraine prevention effects during baseline
• Taken an opioid and/or opioid-containing analgesic ≥ 4 days during baseline for any indication.
• Taken a butalbital and/or butalbital-containing analgesic ≥ 4 days during baseline for any indication.
• Previously treated with any agent (monoclonal antibody or small molecule) targeting the CGRP pathway (ligand or receptor) in preventive settings

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

After subjects complete baseline and are found eligible, they will be enrolled and randomized in a 1:1 ratio to either erenumab or placebo.

Treatment:

Drug: Placebo

Erenumab

Experimental group

Description:

After subjects complete baseline and are found eligible, they will be enrolled and randomized in a 1:1 ratio to either erenumab or placebo.

Treatment:

Drug: Erenumab