Clinical trial NCT05632133: The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
Official title: a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Effect of Drug
Migraine Disorders
Keywords: migraine
lacosamide
Egypt
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We assessed CGRP before and after treatment in two groups of episodic migraine patients; the first group (the lacosamide group) received Ibuprofen 200-400 mg as a treatment for acute migraine attacks and 50 mg lacosamide Bid for 3 months, and the second group (control group) received only Ibuprofen 200-400 mg as a treatment for acute migraine attacks
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: serum CGRP level in lacosamide and control groups
timeFrame: 3 months
Secondary outcomes:
measure: efficacy of lacosamide
timeFrame: 3 months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Elsheikh University Hospital
Study officials:
affiliation: neurology department kafr el-sheikh university
name: mohamed G. Zeinhom, MD,PHD
role: STUDY_DIRECTOR
affiliation: neurology department kafr el-sheikh university
name: mohamed G. Zeinhom, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: neurology department kafr el-sheikh university
name: sherihan R. Ahmed, MSc
role: PRINCIPAL_INVESTIGATOR
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