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

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Migraine

In brief

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.

Key facts

Study ID

NCT01833130

Run by

Allergan

People needed

52

Starts

2013-04-01

Expected to finish

2014-09-01

Last updated by the study team

2015-10-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Study site — San Francisco, California, United States

Full record on ClinicalTrials.gov

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