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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:April 2013
End Date:September 2014

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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.


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.
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