CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 600 enrolled
Drug / intervention
Lacosamide tablet +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05851781
NCT05851781Phase 3Completed

Safety and Efficacy of Lacosamide Versus Propranolol in Migraine

Kafrelsheikh University·interventional·Posted May 10, 2023·Updated May 1, 2024

In Brief

A Phase 3 clinical trial evaluating Lacosamide tablet and Propranolol for Migraine Disorders. Completed, enrolled 600 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 10, 2023
Enrollment StartJun 1, 2022
Primary CompletionJul 30, 2023
Study CompletionAug 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.1 years ago

Interventions

Lacosamide tabletdrug

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

Propranololdrug

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