Valproate Versus Propranolol in Migraine
Valproate Versus Propranolol in Migraine, a Randomized Controlled Trial
Kafrelsheikh University
600 participants
Jan 23, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 years,
Exclusion Criteria7
- 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
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Interventions
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. 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 treatment safety was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. 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 treatment safety was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
Locations(1)
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NCT06485726