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RECRUITINGPhase 3INTERVENTIONAL

Zonisamide Versus Topiramate in Migraine

Safety and Efficacy of Zonisamide Versus Topiramate in Migraine

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Investigators aim to compare the effect of zonisamide 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

Who May Be Eligible (Plain English)

Who May Qualify: - migraine patients, according to the International Classification of Headache Disorders 3rd edition, - age from 10 to 55 years, Who Should NOT Join This Trial: - 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, such as 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 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * migraine patients, according to the International Classification of Headache Disorders 3rd edition, * age from 10 to 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, such as 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 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

Treatments Being Tested

DRUG

Zonisamide 50 MG

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

DRUG

Topiramate 50 MG

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

Locations (1)

Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt