Clinical trial

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

Name

2398816

Description

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.

Trial arms

Trial start

2022-06-01

Estimated PCD

2023-08-09

Trial end

2023-08-10

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

lacosamide group

Ibuprofen 400 mg

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.

Arms:

control group, lacosamide group

Other names:

control

Size

200

Primary endpoint

serum CGRP level in lacosamide and control groups

3 months

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}

Updated at

2024-03-21

1 organization

2 products

2 indications

Organization

Kafrelsheikh University

Product

Indication

Indication

Product