Lacosamide Versus Topiramate in Migraine

Last updated: March 28, 2024
Sponsor: Kafrelsheikh University
Overall Status: Active - Recruiting

Phase

3

Condition

Migraine (Adult)

Oral Facial Pain

Treatment

Topiramate 50Mg Tab

Lacosamide 50 MG

Clinical Study ID

NCT06243692
0000023988
  • Ages 10-55
  • All Genders

Study Summary

Investigators aim to compare the effect of lacosamide 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:

  • Naive migraine patients, according to the International Classification of HeadacheDisorders 3rd edition, aged 10-55 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 like hypertension (systolic blood pressure of morethan 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three differentoccasions, diabetes (fasting plasma glucose level >126 mg/dl and/or a casual plasma glucose >200 mg/dl and/or HbA1C more than 6.5. patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestiveheart failure patients who received prophylactic treatment for migraine, patients with anycontraindications to drugs used in the study Patients with topiramate or lacosamidecontraindications

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Topiramate 50Mg Tab
Phase: 3
Study Start date:
February 01, 2024
Estimated Completion Date:
February 25, 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 50 mg lacosamide twice 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 (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.

Connect with a study center

  • Kafr Elsheikh University Hospital

    Kafr Ash Shaykh, 33511
    Egypt

    Active - Recruiting

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