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RECRUITING
NCT06347497
PHASE3

Zonisamide Versus Topiramate in Migraine

Sponsor: Kafrelsheikh University

View on ClinicalTrials.gov

Summary

Investigators aim to compare the effect of zonisamide versus topiramate 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

Official title: Safety and Efficacy of Zonisamide Versus Topiramate in Migraine

Key Details

Gender

All

Age Range

10 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-04-01

Completion Date

2025-05-01

Last Updated

2024-04-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Zonisamide 50 MG

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess The change in migraine days per 28 days, 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 zonisamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

DRUG

Topiramate 50 MG

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess The change in migraine days per 28 days, 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 topiramate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Locations (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt