Valproate Versus Topiramate in Migraine

Phase 3

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Topiramate 50 MG; Drug: Valproic acid

• Registration Number: NCT06248931
• Lead Sponsor: Kafrelsheikh University

Brief Summary

Investigators aim to compare the effect of valproate versus topiramate in migraine by assessing the 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.

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 ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topiramate arm	Topiramate 50 MG	The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive topiramate 50-100mg daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. 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 valproate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
valproate arm	Valproic acid	The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive valproate 500-1000mg daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. 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 valproate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Primary Outcome Measures

Name	Time	Method
The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency.	3 months	We will assess The percentage of patients who achieved ≥ 50% change in the monthly headache days frequency compared to the baseline frequency in each group
The number of patients who discontinued treatment due to treatment-emergent adverse events.	90 days	The investigator will assess The number of patients who discontinued treatment due to treatment-emergent adverse events in each group after 3 months of treatment

Secondary Outcome Measures

Name	Time	Method
HIT-6 score change in each group after three months of treatment	3 months	The investigators assessed the absolute change in HIT6 score, the Headache Impact Test-6 (HIT-6) assessed the burden of headache in each group; the HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress, the patient answers each of the six related questions using one of the followi...
Treatment safety was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.	3 months	The safety of treatment was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
The monthly migraine days per month	30 days	The investigators will assess the change in migraine days per month in each group.
The severity of migraine attack on VAS score after three months of treatment	3 months	After three months of treatment, the investigators will assess the severity of migraine attacks on VAS scores.; VAS is scale from one to ten where one is the least severe pain while ten is the severest pain
The duration of migraine attack in hours after three months of treatment	3 months	After three months of treatment, the investigators will assess the duration of migraine attacks in hours in each group

Trial Locations

Locations (1)

Kafr Elsheikh University Hospital; 🇪🇬 Kafr Ash Shaykh, Egypt