NCT05632133

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 10 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Effect of Drug
• Migraine Disorders

Interventions

Type	Name	Description
DRUG	Lacosamide 50 MG Oral Tablet	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.
DRUG	Ibuprofen 400 mg	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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-08-09
• Completion: 2023-08-10
• First posted: 2022-11-30
• Last updated: 2024-03-21

Locations

1 site across 1 country: Egypt