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Safety and Efficacy of Lacosamide Versus Propranolol in Migraine
Investigators aim to compare the effect of lacosamide 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 50 mg lacosamide twice daily, and the second group will receive propranolol 160 mg per day. 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 (14). 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
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt
Start Date
June 1, 2022
Primary Completion Date
July 30, 2023
Completion Date
August 30, 2023
Last Updated
May 1, 2024
600
ACTUAL participants
Lacosamide tablet
DRUG
Propranolol
DRUG
Lead Sponsor
Kafrelsheikh University
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05690737