Lacosamide Versus Topiramate in Migraine, a Ranodmized Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The change in migraine days per 28 days
研究概览
简要总结
Investigators aim to compare the effect of lacosamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.
详细描述
Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 50 mg lacosamide twice daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive topiramate100 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14).. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either lacosamide or topiramate from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrolment numbers starting from 1, which were mentioned on their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included lacosamide, and Drug B included propranolol. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B.
Both groups received open-label 500-1000mg acetaminophen during acute attack.
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, liver, 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, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study Patients with topiramate or lacosamide contraindications
研究组 & 干预措施
lacosamide arm
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive Lacosamide 50 mg twice daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
干预措施: Lacosamide 50 MG (Drug)
Topiramate arm
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive topiramate 100 mg daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
干预措施: Topiramate 50Mg Tab (Drug)
结局指标
主要结局
The change in migraine days per 28 days
时间窗: 28 days
The investigators will assess the change in migraine days per 28 days in each group.
次要结局
- The total number of migraine days after three months of treatment(3 months)
- The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency.(3 months)
- HIT-6 score absolute reduction in each group after three months of treatment(3 months)
- The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.(3 months)
研究者
Mohamed G. zeinhom, MD
Dr.
Kafrelsheikh University