Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.

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

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• History of chronic migraine for at least 6 months prior to the screening visit

• Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)

Exclusion Criteria:

• Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia

• Use of headache prophylaxis medication within 4 weeks of the screening visit

• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

• Previous use of any botulinum toxin of any serotype for any reason

• Skin infections or acne that would interfere with the injection sites

• Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of screening.