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

Phase 3

Completed

• Conditions: Migraine Disorders; Effect of Drug
• Interventions: Drug: Lacosamide 50 MG Oral Tablet; Drug: Ibuprofen 400 mg

• Registration Number: NCT05632133
• Lead Sponsor: Kafrelsheikh University

Brief 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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-30
• Primary Completion: 2023-08-09
• Study Completion: 2023-08-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Naive migraine patients according to the International Classification of Headache Disorders 3rd edition aged 10-55 years,

Exclusion Criteria

• Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.
• patients with major systemic diseases such as malignancy, collagen diseases, liver diseases, and renal diseases.
• patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, diabetes (fasting plasma glucose level >126 mg/dl and/or a casual plasma glucose >200 mg/dl and/or HbA1C more than 6.5.
• patients with valvular and ischemic heart diseases,
• patients who received prophylactic treatment for migraine,
• patients with any contraindications to lacosamide.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lacosamide group	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.
lacosamide group	Ibuprofen 400 mg	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.
control group	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.

Primary Outcome Measures

Name	Time	Method
serum CGRP level in lacosamide and control groups	3 months	Approximately 5 ml of venous blood was drawn from all participants and then centrifuged at 1000×g for 10 min. Serums were separated from the blood sample and stored at - 20℃.; The serum CGRP concentration was measured before starting treatment and after 3 months of treatment by adapting the enzyme-linked immunosorbent assay (ELISA) kit following manufacturer protocols.

Secondary Outcome Measures

Name	Time	Method
efficacy of lacosamide	3 months	We compared the monthly migraine days change in both the lacosamide and control groups.

Trial Locations

Locations (1)

Kafr Elsheikh University Hospital; 🇪🇬 Kafr Ash Shaykh, Egypt