Valproate Versus Topiramate in Migraine

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Description

Investigators aim to compare the effect of valproate 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.

Targeted Conditions

Study Overview

Start Date
February 1, 2024
Completion Date
February 20, 2025
Enrollment
600
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Kafr Elsheikh University Hospital
Kafr Ash Shaykh 33155, Egypt

Eligibility

Minimum Age (years)
10
Maximum Age (years)
55
Eligibility Criteria
Inclusion Criteria:

- Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years,

Exclusion Criteria:

Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.

Patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases.

Patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, 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, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study Patients with topiramate or valproate contraindications

Study Contact Info

Study Contact Name
mohamed G. Zeinhom, MD; sherihan R. ahmed, MD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
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 300-1000mg valproate 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.
NCTid (if applicable)
NCT06248931