Zonisamide Versus Topiramate in Migraine

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

Phase

3

Condition

Chronic Pain

Oral Facial Pain

Migraine (Adult)

Treatment

Topiramate 50 MG

Zonisamide 50 MG

Clinical Study ID

NCT06347497
000001230988
  • Ages 10-55
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • migraine patients, according to the International Classification of Headache Disorders 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 major systemic diseases such as malignancy, collagen, liver, and renaldiseases.
  • Patients with cardiovascular diseases, such as hypertension (systolic blood pressureof more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at leastthree different occasions), diabetes (fasting plasma glucose level >126 mg/dl and/orcasual plasma glucose >200 mg/dl), and/or HbA1C more than 6.5.
  • Patients with valvular and ischemic heart diseases, bradycardia or heart blocks,congestive heart failure patients who received prophylactic treatment for migraine,patients with any contraindications to drugs used in the study patients with bronchialasthma, chronic obstructive pulmonary disease

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Topiramate 50 MG
Phase: 3
Study Start date:
April 01, 2024
Estimated Completion Date:
May 01, 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 topiramate100 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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