Zonisamide Versus Propranolol in Migraine, a Randomized Controlled Single-blinded Trial

023098816

Investigators aim to compare the effect of zonisamide versus propranolol 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

2024-03-29

2025-03-30

2025-04-20

Recruiting

Early phase I

600

Inclusion Criteria: * Naive 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 malignancy, collagen, liver, and renal diseases. patients with cardiovascular diseases like hypertension and diabetes 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We 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. 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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or propranolol and acetaminophen from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included zonisamide and acetaminophen, and Drug B included propranolol and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B.", 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

2024-04-23