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

Plain-language summary

This study examines the effect of the drug Lacosamide on a molecule called calcitonin gene-related peptide in people with migraine (severe headache attacks) and compares it with Ibuprofen. Previously untreated migraine patients aged 10 to 55, diagnosed per international criteria, could take part. The study was carried out in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Kafrelsheikh University

Intervention

Lacosamide 50 MG Oral Tablet, Ibuprofen 400 mg

Start date

6/1/2022

Estimated completion

8/10/2023

Countries

Egypt

Related genes

Locations

• Kafr ash Shaykh, Egypt

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.