Lacosamide versus topiramate in episodic migraine: a randomized controlled double-blinded trial.

BACKGROUND

Although migraine is the second most prevalent form of headache, its preventive treatment has some contraindications and complications. It has been postulated that lacosamide reacts with collapsin response mediator protein 2 and prevents its phosphorylation, inhibiting calcitonin gene-related peptide release in the trigeminal system, which might have a role in migraine management.

OBJECTIVE

Our study aimed mainly to evaluate the efficacy and safety of lacosamide as an alternative medication to topiramate for the prevention of migraine, especially in patients who had contraindications to topiramate and other approved antiseizure medications used for migraine prevention.

DESIGN

Our study included two parallel groups: the lacosamide and the topiramate groups.

METHODS

We recruited episodic migraine patients between the ages of 18 and 65; the lacosamide group received lacosamide 50 mg once daily for 1 week, then twice daily from the 8th day till the 90th day); while the topiramate group received topiramate 50 mg once daily for 1 week, then 50 mg twice daily from the 8th day till the 90th day.

RESULTS

There was not a statistically significant difference between the lacosamide and topiramate in the absolute change in monthly migraine days (MMD) at 90 days with p-value 0.34, there was no significant difference between lacosamide and topiramate groups regarding the percentage of patients with ⩾50% reduction in the baseline migraine days frequency in the last 4 weeks of the treatment period with a p-value 0.11. In total, 14.0 (4.7%) patients in the lacosamide group and 24.0 (8.0%) in the topiramate group stopped treatment prematurely due to intolerance to drug-related adverse effects, hazard ratio 2.83, 95% confidence interval (1.34-4.72), p-value 0.03.

CONCLUSION

In episodic migraine patients, the regular use of lacosamide 50 mg Bid for 3 months yielded reductions in the MMD, migraine days that required acute medications, and Headache Impact Test-6 score comparable to those achieved using topiramate 50 mg Bid. Lacosamide was more tolerable than topiramate in episodic migraine patients.

TRIAL REGISTRATION: Prospectively registered on clinicaltrials.gov, NCT06243692-January 29, 2024; https://clinicaltrials.gov/study/NCT06243692.