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 on the presence of significant comorbidities. Participants with comorbidities and medication regimens commonly exhibited within real-world DOD medical settings will not be excluded, such as pain disorders, psychiatric illness, medication overuse, and those who have used prophylactic medication during the baseline period. This will comprise "Group A". A carefully screened group will comprise "Group B" and meet exclusion criteria designed to approximate that of the PREEMPT2 trial. Within each group, half of the patients (155U Arm) will be randomly selected to receive the standard 155U over 31 fixed sites every 12 weeks while the other half (100U Arm) will receive 100U over 19 fixed sites every 12 weeks. Minimum sample size for the entire cohort is 132 participants (maximum n = 180), with a minimum of 66 participants per comparison.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
35
Randomized to either 100U or 155U
Naval Medical Center San Diego
San Diego, California, United States
mean change in frequency of headache days for the baseline period compared to the 28-day period ending with week 24
Time frame: 24 weeks
frequency of migraine days
Time frame: 24 weeks
proportion of patients with severe (>=60) HIT-6 score
Time frame: 24 weeks
acute headache pain medication intakes
Time frame: 24 weeks
mean change in total HIT-6
Time frame: 24 weeks
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