Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2025-12-17 @ 7:43 AM
Study NCT ID:
NCT06361446
Status:
None
Last Update Posted:
2024-04-23 00:00:00
First Post:
2024-03-28 00:00:00
Brief Title:
Zonisamide Versus Propranolol in Migraine
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Zonisamide Versus Propranolol in Migraine, a Randomized Controlled Single-blinded Trial
Status:
None
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators will enroll 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 100mg zonisamide daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive propranolol 160 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. 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. 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.
Detailed Description:
Investigators will enroll 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 100mg zonisamide daily and Acetaminophen 500-1000 mg in acute attack and the second group will receive propranolol 160 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None