a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- serum CGRP level in lacosamide and control groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naive migraine patients according to the International Classification of Headache Disorders 3rd edition aged 10-55 years,
排除标准
- •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.
- •patients with valvular and ischemic heart diseases,
- •patients who received prophylactic treatment for migraine,
- •patients with any contraindications to lacosamide.
研究组 & 干预措施
lacosamide group
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.
干预措施: Lacosamide 50 MG Oral Tablet (Drug)
lacosamide group
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.
干预措施: Ibuprofen 400 mg (Drug)
control group
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.
干预措施: Ibuprofen 400 mg (Drug)
结局指标
主要结局
serum CGRP level in lacosamide and control groups
时间窗: 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.
次要结局
- efficacy of lacosamide(3 months)
研究者
Mohamed G. zeinhom, MD
prinicipal investigator
Kafrelsheikh University