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Zonisamide Versus Propranolol in Migraine, a Randomized Controlled Single-blinded Trial
Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency
Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 100mg zonisamide daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive propranolol 160 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
Age
10 - 55 years
Sex
ALL
Healthy Volunteers
No
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt
Start Date
March 29, 2024
Primary Completion Date
March 30, 2025
Completion Date
April 20, 2025
Last Updated
April 23, 2024
600
ESTIMATED participants
Zonisamide 50 MG
DRUG
Propranolol
DRUG
Lead Sponsor
Kafrelsheikh University
NCT06641466
NCT07018713
NCT04715685
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