NCT06361446

Zonisamide Versus Propranolol in Migraine

Zonisamide Versus Propranolol in Migraine, a Randomized Controlled Single-blinded Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 10 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Zonisamide 50 MG	The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. all patients received zonisamide 100 mg daily and acetaminophen 500-1000 mg on migraine attack. 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	Propranolol	The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients received propranolol 160 mg daily and acetaminophen 500-1000 mg on migraine attack. 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 lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Timeline

• Start date: 2024-03-29
• Primary completion: 2025-03-30
• Completion: 2025-04-20
• First posted: 2024-04-11
• Last updated: 2024-04-23

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study