Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851781
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2023-04-30
Brief Title:
Lacosamide Versus Propranolol in Migraine
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Safety and Efficacy of Lacosamide Versus Propranolol in Migraine
Status:
COMPLETED
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 aim to compare the effect of lacosamide 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
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 50 mg lacosamide twice daily and the second group will receive propranolol 160 mg per day 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 14 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None