Efficacy of Memantine Compared With Sodium Valproate in the Prophylactic Treatment of Episodic Migraine.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS).
研究概览
简要总结
Migraine is one of the three most disabling diseases worldwide. Constituted by recurrent episodes of headache, characterized by unilateral location, throbbing character, moderate or severe intensity, worsening with physical activity, and association with nausea or photophobia and/or phonophobia. There are two types of drug treatment: abortifacient and prophylactic. The American Academy of Neurology classifies sodium valproate as level A; however, some patients do not obtain a satisfactory response rate and/or have adverse effects. Therefore, the search for new pharmacological treatments continues. In 2015, a double-blind, randomized clinical trial with a placebo was carried out to assess Memantine's efficacy in the prophylactic treatment of migraine without aura, which reported a reduction of 2.3 migraine attacks per month compared to the placebo group. Memantine could be a new effective treatment alternative, which is why we will compare the efficacy of Memantine against sodium valproate as a prophylactic migraine treatment.
Main objective: To compare the efficacy of Memantine at a rate of 20mg divided into two doses a day against sodium valproate (VPA) at a rate of 1000mg divided into two doses a day prophylactic treatment of migraine for three months.
Study design: a prospective controlled, randomized, double-blind clinical trial. Inclusion criteria: Men and women aged 18 to 65 years with a diagnosis at least one year before the study must present at least 2 to 8 migraine attacks per month and less than 15 days with headache per month, which should not be receiving prophylactic treatment for migraine and sign an informed consent
Sample size calculation and statistical analysis:
It is calculated using the normal distribution model, where the recommended sample size is 196 participants. Since a pilot study will be conducted, 10% of the sample size will be taken to make it representative, a sample size of 20 participants is decided for each group.
详细描述
Migraine is a primary headache, currently one of the three most disabling diseases globally. It has an annual and lifetime prevalence of 18% and 33% in women, and 6 to 13% in men, respectively, with a predominance in women (3: 1). The age of onset with the highest prevalence is between 25 and 55 years.
Migraine is described by the International Headache Society (IHS) as recurrent episodes of headache lasting 4 to 72 hours, characterized by unilateral location, pulsatile character, moderate or severe intensity, worsening with physical activity, and association with nausea or photophobia and phonophobia. The IHS also classifies migraine based on the frequency of attacks: episodic migraine when the headache occurs on less than 15 days a month, and chronic migraine, when the headache occurs 15 or more days a month for three months and at least eight days a month with characteristics of migraine headache.
The subtypes of migraine concerning their clinical presentation are migraine with aura and without aura.4 Up to one-third of patients present migraine aura, with visual symptoms being the most frequent.
Four phases have been identified during a migraine: prodromal phase, aura, headache, and postdrome. The prodromal phase is characterized by premonitory symptoms hours before the headache, including difficulty concentrating, irritability, fatigue, repetitive yawning, stiff neck, and photophobia.
Recurrent episodes characterize the aura, lasting from 5min to 60min, with transient unilateral visual, sensory, or other CNS symptoms that develop progressively, usually precede headache and symptoms associated with migraine.4 The aura's genesis is activated by the NMDA (N-methyl-D-aspartate) receptor and disseminated cortical depression. Disseminated cortical depression is an extreme depolarization of the cell membranes of the glia and neurons that produce an alteration of the ionic gradient, an increase in extracellular potassium concentrations, glutamate release, and a transient increase followed by a decrease in cerebral blood flow.
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
- Single (Investigator)
盲法说明
The clinician will make an evaluation and if the patient has the criteria for inclusion will be by randomization in one group or another. Neither the clinician and the patient will not know the administrated treatment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women from 18 to 65 years old.
- •Diagnosis of migraine according to the ICHD-III of the IHS at least one year before the study.
- •You must have at least 4-14 migraine attacks per month.
- •Not receiving prophylactic treatment for migraine
- •Sign informed consent
排除标准
- •Pregnant or lactating patients.
- •Patients with another type of non-migraine headache.
- •Allergy to Sodium Valproate and/or Memantine
- •Being a carrier of systemic disease (infectious, immunological, or metabolic processes) or cardiovascular (myocardial, coronary, or valvular disease) prevents their participation in the study.
研究组 & 干预措施
Valproate group
This is a well know antiepileptic drug with efficacy as a preventive tic treatment in episodic migraine
干预措施: Valproate Sodium (Drug)
Memantine
This is a possible preventive treatment in episodic migraine
干预措施: Memantine (Drug)
结局指标
主要结局
The Change in the Intensity of the Pain in a Migraine Attack Will be Measured by a Visual Analogue Scale (VAS).
时间窗: Three months previous and three months after the treatment.
The possible reduction in the average on the visual analog scale (0-10) comparing three months before and after three months of the treatment with both drugs. We measured both arms of the study. 0 means without pain. 10 means the worst possible pain in the concept of the patient.
Reduction in Days of Headache Pain With Treatment of Memantine or Valproate in the Preventive Management of Episodic Migraine.
时间窗: Three months before treatment (Pretreatment), three months after initiating treatment (post-treatment)
In a double-blind clinical trial, we compared two active drugs (mamantine vs. valproate) three months after initiation, looking for changes in the average number of days of migraine attack presentation per month and comparing the three months before with the three months after treatment administration with two active drugs.
The Migraine Disability Assessment MIDAS Scale Will Measure Before and After the Treatment to Improve the Quality of Life in Both Groups After Three Months of Treatment.
时间窗: Three months.
To compare the average of Memantine against the group that receives Valproate before and after starting preventive treatment. Using the Migraine Disability Assessment scale (The score is the sum of days missed from work or school, days of housework missed, days of missed non-work activities, and days of work or school plus days of housework in which productivity in the last three months) to compare punctuation changes. The MIDAS score is divided into four degrees, the minimum score is 0 points, and the maximum score is 70. A higher value represents a higher difficulty to carry out a satisfactory lifestyle, and a score higher than 20 points already represents a high limitation to enjoying daily activities: Grade I (0-5 points): Slight limitations and few patient treatment needs. Grade II (6-10 points): Moderate limitations and treatment needs. Grade III (11-20 points) and IV (21 or more points): Severe and significant punctuation treatment needs.
次要结局
- Measure Changes in Weight With the Administration of Active Drugs.(Three months)
研究者
Ildefonso Rodriguez-Leyva
MD, PhD, FAAN, FANA
Universidad Autonoma de San Luis Potosí