CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
Lacosamide 50 MG Oral Tablet +1 moredrug
Likely dose
Lacosamide 50 MG Oral Tabletfrom 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/NCT05632133
NCT05632133Phase 3Completed
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a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients

Kafrelsheikh University·interventional·Posted Nov 30, 2022·Updated Mar 21, 2024

In Brief

A Phase 3 clinical trial evaluating Lacosamide 50 MG Oral Tablet and Ibuprofen 400 mg for Effect of Drug and Migraine Disorders. Completed, enrolled 200 participants across 1 site.

Detailed Summary

We assessed serum CGRP concentrations before and after treatment in two hundred episodic migraine patients according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years. We divided them into two groups first one received Ibuprofen 200-400 mg as a treatment for acute migraine attacks and lacosamide 50 mg Bid for 3 months, and the other group received only Ibuprofen 200-400 mg as a treatment for acute migraine attacks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEffect of Drug, Migraine Disorders
CountriesEgypt
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedNov 30, 2022
Enrollment StartJun 1, 2022
Primary CompletionAug 9, 2023
Study CompletionAug 10, 2023
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 3.6 years ago

Interventions

Lacosamide 50 MG Oral Tabletdrug

We assessed the serum level of CGRP before and after 3 months of treatment in 100 episodic migraine patients receiving 50 mg lacosamide Bid and Ibuprofen 200-400 mg only during migraine attacks.

Ibuprofen 400 mgdrug

We assessed the serum level of CGRP before and after 3 months of treatment in 100 episodic migraine patients receiving Ibuprofen 200-400 mg only during migraine attacks.