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NCT Number: NCT06248931

Valproate Versus Topiramate in Migraine

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33155, Egypt

About this study

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 500-1000mg 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 treatment was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valproic acid

Drug

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive valproate 500-1000 mg 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.

Other names: group A

Topiramate 50 MG

Drug

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive topiramate 50-100 mg 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 topiramate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Other names: group B

Primary outcomes

  1. The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency.

    Time frame: 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

  2. The number of patients who discontinued treatment due to treatment-emergent adverse events.

    Time frame: 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 outcomes

  1. The severity of migraine attack on VAS score after three months of treatment

    Time frame: 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

  2. HIT-6 score change in each group after three months of treatment

    Time frame: 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 following five responses: "never", "rarely", "sometimes", "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. It has four impact grades: little-to-no impact (HIT-6 score: 36-49), moderate impact (HIT-6 score: 50-55), substantial impact (HIT-6 score: 56-59), and severe impact (HIT-6 score: 60-78)

  3. Treatment safety was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.

    Time frame: 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.

  4. The monthly migraine days per month

    Time frame: 30 days

    The investigators will assess the change in migraine days per month in each group.

  5. The duration of migraine attack in hours after three months of treatment

    Time frame: 3 months

    After three months of treatment, the investigators will assess the duration of migraine attacks in hours in each group

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Valproate Versus Topiramate in Migraine, a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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