DRUG
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.
Status
Completed
Phase
Phase 3
Enrollment
200
Locations
1
Results
Not posted
Publications
6
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.
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.
Interventions
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.
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.
Timeline
First posted
Nov 30, 2022
Study start
Jun 1, 2022
Primary completion
Aug 9, 2023
Study completion
Aug 10, 2023
Results posted
Not reported
Registry updated
Mar 21, 2024
Outcomes
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.
efficacy of lacosamide
Time frame · 3 months
We compared the monthly migraine days change in both the lacosamide and control groups.
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.
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt
Publications
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