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Completed

NCT Number: NCT05632133

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

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.

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Key information

Age range

10 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

About this study

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

  • detailed history taking with stress on Age, sex, and criteria and type of migraine
  • general examination
  • full neurological examination: Full neurological examination
  • Laboratory investigations include: Serum creatinine, Liver functions test to exclude any metabolic disorder.
  • 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.
  • Serum level CGRP before starting treatment and after three months of treatment
  • MRI T1, T2, and flair to exclude any secondary cause of headache.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lacosamide 50 MG Oral Tablet

Drug

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 mg

Drug

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.

Other names: control

Primary outcomes

  1. serum CGRP level in lacosamide and control groups

    Time frame: 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 outcomes

  1. efficacy of lacosamide

    Time frame: 3 months

    We compared the monthly migraine days change in both the lacosamide and control groups.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2022
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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