Valproate Versus Propranolol in Migraine
- Conditions
- Migraine Disorders
- Interventions
- Drug: Valproic Acid 500 MG
- Registration Number
- NCT06485726
- Lead Sponsor
- Kafrelsheikh University
- Brief Summary
Investigators aim to compare the effect of valproate versus propranolol in migraine by assessing the absolute reduction in MMD in each group and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.
- Detailed Description
Investigators will enrol 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 500-1000 mg valproate daily, and the second group will receive propranolol 160 mg per day. 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 years,
- Patients with major neurological disorders such as (epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumours, 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 bronchial asthma, chronic obstructive pulmonary disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description valproate arm Valproic Acid 500 MG The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive valproate 500-1000 mg daily for three 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. Treatment safety was evaluated by monitoring and documenting patients' treatment-emergent adverse events (TEAE) through regular follow-up procedures for three months. Propranolol group Propranolol The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive propranolol 160 mg once daily 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 lacosamide 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 change in migraine days per 28 days 28 days The investigators will assess the change in migraine days per 28 days in each group.
- Secondary Outcome Measures
Name Time Method The total number of migraine days after three months of treatment 3 months The investigators will assess the total migraine days after three months of regular use of 500-1000 mg valproate daily or propranolol (160 mg once daily).
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% reduction in the monthly headache days frequency compared to the baseline frequency in each group
HIT-6 score absolute 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) evaluated 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 more significant impact of headaches 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)
Incidence of Treatment-Emergent Adverse Events 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.
Trial Locations
- Locations (1)
Kafr Elsheikh University Hospital
🇪🇬Kafr Ash Shaykh, Egypt