Status:
TERMINATED
Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?
Lead Sponsor:
United States Naval Medical Center, San Diego
Conditions:
Chronic Migraine, Headache
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will enroll patients through the Neurology Department at Naval Medical Center San Diego (NMCSD). Eligible participants will meet criteria for chronic migraine, but will not be excluded based...
Eligibility Criteria
Inclusion
- Chronic migraine headache - Diagnostic criteria:
- A. Headache (tension-type-like and/or migraine-like) on 15 days per month for \>3 months2 and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura
- C. On 8 days per month for \>3 months, fulfilling any of the following 3 :
- criteria C and D for 1.1 Migraine without aura
- criteria B and C for 1.2 Migraine with aura
- believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis. -
Exclusion
- Previous exposure at any time to any botulinum toxin serotype Pregnancy, breastfeeding or plans to become pregnant within 6 months Age \<18 years Failure to complete at least 20 days of headache diary in the 28 day baseline period
Key Trial Info
Start Date :
May 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04349176
Start Date
May 12 2017
End Date
December 31 2022
Last Update
February 5 2024
Active Locations (1)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134