NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 191
- 试验地点
- 39
- 主要终点
- Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline
研究概览
简要总结
The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.
详细描述
Chronic migraine affects about 2 percent of all adults. Currently there are no effective preventative treatments to deal with this disabling condition. Three randomized, placebo-controlled trials found that topiramate was an effective, safe and generally well-tolerated drug for treating chronic migraine. As a result of these trials, topiramate is becoming the standard treatment among headache specialists. Experts agree that treatment with combinations of preventive agents is required in the majority of individuals with chronic migraine for maximal headache relief. No randomized trials have assessed the value of frequently used combinations of preventive agents for chronic migraine.
The goal of this trial is to determine if adding a second drug to topiramate treatment will further reduce the headache burden for people with this condition. In the study, 250 participants with chronic migraine will be randomized to two groups - treatment with topiramate and propranolol or topiramate and placebo. Participants will be followed for six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of chronic migraine for at least 6 months
- •Age ≥ 18 years and age of migraine onset 60 or younger
- •EKG performed in the last 12 months
排除标准
- •Prior neuro-imaging suggesting secondary structural causes of headache
- •Beck Depression Inventory FastScreen score of 13 or greater or other severe psychiatric disorder
- •Contraindication to or prior intolerance of topiramate or propranolol (no history of sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma, kidney stones)
- •History of kidney failure or nephrolithiasis
- •A female who is currently pregnant or lactating or planning to become pregnant in the next year, or is of child-bearing potential and not practicing an acceptable form of birth control
- •Currently requires butalbital or opioid drugs for acute headache treatment 10 or more days a month
- •Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg of propranolol
- •Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 in the AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin, amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker, cyproheptadine; and tizanidine) within the last two months or has received botulinum toxin injection in the past 3 months
研究组 & 干预措施
1
Participants will receive propranolol and topiramate.
干预措施: propranolol LA (Drug)
1
Participants will receive propranolol and topiramate.
干预措施: topiramate (Drug)
2
Participants will receive a placebo and topiramate.
干预措施: topiramate (Drug)
2
Participants will receive a placebo and topiramate.
干预措施: placebo (Drug)
结局指标
主要结局
Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline
时间窗: Baseline (pre-randomization), months 5 and 6 post randomization
(Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).
次要结局
- Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days(6 months post randomization)
- Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days(6 months)
- Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months(Baseline and 6 months)
- Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months(Baseline and 6 months)
- Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months(baseline and 6 months post randomization)
- Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months(Baseline and 6 months)
- Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months(Baseline and 6 Months)
研究者
Anne Lindblad
Executive Vice President, The EMMES Corporation
The Emmes Company, LLC