Zonisamide Versus Propranolol in Migraine

Last updated: April 20, 2024
Sponsor: Kafrelsheikh University
Overall Status: Active - Recruiting

Phase

3

Condition

Pain

Oral Facial Pain

Headaches

Treatment

Propranolol

Zonisamide 50 MG

Clinical Study ID

NCT06361446
023098816
  • Ages 10-55
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Naive migraine patients, according to the International Classification of HeadacheDisorders 3rd edition,
  • age from 10 to 55 years

Exclusion

Exclusion Criteria: Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagicstroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients withessential tremors. patients with malignancy, collagen, liver, and renal diseases. patients with cardiovasculardiseases like hypertension and diabetes patients with valvular and ischemic heart diseases,bradycardia or heart blocks, congestive heart failure patients who received prophylactictreatment for migraine, patients with any contraindications to drugs used in the studypatients with bronchial asthma, chronic obstructive pulmonary disease

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Propranolol
Phase: 3
Study Start date:
March 29, 2024
Estimated Completion Date:
April 20, 2025

Study 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.

Connect with a study center

  • Kafr Elsheikh University Hospital

    Kafr Ash Shaykh, 33511
    Egypt

    Active - Recruiting

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