A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine

Amgen

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: Erenumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04825678

20190389

Details and patient eligibility

About

The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.

Enrollment: 240 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Participant has provided informed consent
• History of migraine (with or without aura) for ≥ 12 months before screening
• ≥ 4 migraine days per month on average across the 3 months prior to screening
• Treatment with 1 oral migraine preventive medication and/or concomitant use of OnabotulinumtoxinA injections for migraine prevention.
• Participant reports to their provider intolerance or insufficient response with their current preventative treatment

Exclusion criteria

• History of cluster headache or hemiplegic migraine headache
• Unable to differentiate migraine from other headaches
• Evidence of substance-related disorders
• Active chronic pain syndromes (eg, fibromyalgia and chronic pelvic pain)
• No therapeutic response with > 3 migraine preventive medication categories
• Used a prohibited medication, device, or procedure
• Other clinically significant disorder, condition, or disease

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

Erenumab

Experimental group

Treatment:

Drug: Erenumab