protocolSection identificationModule nctId: NCT06361446, orgStudyIdInfo id: 023098816, briefTitle: Zonisamide Versus Propranolol in Migraine, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Migraine, designModule 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, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Zonisamide 50 MG, interventions name: Propranolol, outcomesModule primaryOutcomes measure: The change in migraine days per 28 days, secondaryOutcomes measure: The total number of migraine days after three months of treatment, secondaryOutcomes measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency., secondaryOutcomes measure: HIT-6 score absolute change in each group after three months of treatment, secondaryOutcomes measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months., eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Kafr Elsheikh University Hospital, status: RECRUITING, city: Kafr Ash Shaykh, zip: 33511, country: Egypt, contacts name: mohamed G. Zeinhom, MD, role: CONTACT, phone: 2001009606828, email: mohamed_gomaa@med.kfs.edu.eg, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False