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

Last updated: March 19, 2024
Sponsor: Kafrelsheikh University
Overall Status: Completed

Phase

3

Condition

Oral Facial Pain

Migraine (Adult)

Treatment

Ibuprofen 400 mg

Lacosamide 50 MG Oral Tablet

Clinical Study ID

NCT05632133
2398816
  • Ages 10-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagicstroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients withessential tremors.
  • patients with major systemic diseases such as malignancy, collagen diseases, liverdiseases, and renal diseases.
  • patients with cardiovascular diseases like hypertension (systolic blood pressure ofmore than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least threedifferent occasions, diabetes (fasting plasma glucose level >126 mg/dl and/or a casualplasma 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

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Ibuprofen 400 mg
Phase: 3
Study Start date:
June 01, 2022
Estimated Completion Date:
August 10, 2023

Study 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.

Connect with a study center

  • Kafr Elsheikh University Hospital

    Kafr Ash Shaykh, 33511
    Egypt

    Site Not Available

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