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Zonisamide Versus Propranolol in Migraine

NCT06361446 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-04-23

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • mohamed G. Zeinhom, MD · neurology department kafr el-sheikh university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2025-03-30
Completion
2025-04-20
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06361446 on ClinicalTrials.gov