Status:
COMPLETED
Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
Lead Sponsor:
Allergan
Conditions:
Chronic Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01833130
Start Date
April 1 2013
End Date
September 1 2014
Last Update
October 21 2015
Active Locations (1)
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1
San Francisco, California, United States