Valproate Versus Topiramate in Migraine

PHASE3CompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

May 1, 2022

Primary Completion Date

June 10, 2024

Study Completion Date

June 30, 2024

Conditions
Migraine Disorders
Interventions
DRUG

Valproic acid

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive valproate 500-1000 mg daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. 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 valproate 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. All patients will receive topiramate 50-100 mg daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. 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.

Trial Locations (1)

33155

Kafr Elsheikh University Hospital, Kafr ash Shaykh

All Listed Sponsors
lead

Kafrelsheikh University

OTHER