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The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients

Migraine Disorders Clinical Trial

Official title:
a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients

Clinical Trial 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.

Clinical Trial Description

Two hundred episodic migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years with migraines. 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. Our selected patients were naive and didn't receive any other prophylactic therapy for migraine. for each patient, the investigators did 1. detailed history taking with stress on Age, sex, and criteria and type of migraine 2. general examination 3. full neurological examination: Full neurological examination 4. Laboratory investigations include: Serum creatinine, Liver functions test to exclude any metabolic disorder. 5. Approximately 5 ml of venous blood was drawn from all participants and centrifuged at 1000×g for 10 min. Serums were separated from the blood sample and stored at - 20 ℃. The serum calcitonin gene-related peptide (CGRP) concentrations will be measured by adapting the enzyme-linked immunosorbent assay (ELISA) kit following manufacturer protocols. 6. Serum level CGRP before starting treatment and after three months of treatment 7. MRI T1, T2, and flair to exclude any secondary cause of headache. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05632133
Study type Interventional
Source Kafrelsheikh University
Contact
Status Completed
Phase Phase 3
Start date June 1, 2022
Completion date August 10, 2023
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