Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- reduction of total number of headache days (by diary log)
研究概览
简要总结
Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as compared with 50 mg/day topiramate.
详细描述
Chronic migraine (CM) is a prevalent and devastating disorder with limited therapeutic options. This study explored the efficacy of 10 mg/day flunarizine for CM prophylaxis as compared with 50 mg/day topiramate.
We conducted a prospective, randomized, open-label, blinded-endpoint (PROBE) trial. Patients with CM were randomized (1:1) to flunarizine and topiramate treatment groups.
This study consisted of two periods: a prospective baseline screening period lasting up to 2 weeks (week -2 to week 0, T0), and a treatment period lasting 8 weeks after enrollment (weeks 0-8, T1-T4).
The treatment phase consisted of a 2-week titration period (T1) and a 6-week maintenance period (T2-T4). During the titration period, subjects were given 25 mg/day topiramate or 5 mg/day flunarizine once daily in the first week, followed by 50 mg/day topiramate or 10 mg/day flunarizine in divided doses (twice daily) in the second week. When subjects could not tolerate this target dose, the initial dose was continued through T4.
Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected and directed to the outcome evaluators, who were blinded to the patients' treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICHD-IIR criteria for CM (as reported by the patient)
- •Experienced ≥7 days of headache lasting ≥30 min during T0 (-2 week to 0 week).
- •On ≥4 of these days, subjects were required to have experienced migrainous headache
- •Prophylaxis-naïve (i.e., patients could not receive any preventive medications)
- •With and without medication overuse
排除标准
- •Headache type other than CM
- •Migraine onset after the age of 50 years
- •CM onset after the age of 60 years
- •Previous history of migraine prophylaxis before enrollment
- •Pregnancy or nursing status
- •History of hepatic or renal disorder, nephrolithiasis or other severe systemic disease
- •Severe depression (BDI score ≥ 30 at visit 1)
- •Conditions incompatible with MRI, such as claustrophobia or metallic or electric implants
研究组 & 干预措施
flunarizine
This study consisted of two periods: a prospective baseline screening period lasting up to 2 weeks (week -2 to week 0, T0), and a treatment period lasting 8 weeks after enrollment (weeks 0-8, T1-T4).
The treatment phase consisted of a 2-week titration period (T1) and a 6-week maintenance period (T2-T4). During the titration period, subjects were given 5 mg/day flunarizine once daily in the first week, followed by 10 mg/day flunarizine in divided doses (twice daily) in the second week. When subjects could not tolerate this target dose, the initial dose was continued through T4.
干预措施: Flunarizine (Drug)
topiramate
This study consisted of two periods: a prospective baseline screening period lasting up to 2 weeks (week -2 to week 0, T0), and a treatment period lasting 8 weeks after enrollment (weeks 0-8, T1-T4).
The treatment phase consisted of a 2-week titration period (T1) and a 6-week maintenance period (T2-T4). During the titration period, subjects were given 25 mg/day topiramate once daily in the first week, followed by 50 mg/day topiramate in divided doses (twice daily) in the second week. When subjects could not tolerate this target dose, the initial dose was continued through T4.
干预措施: Topiramate (Drug)
结局指标
主要结局
reduction of total number of headache days (by diary log)
时间窗: week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0)
Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected, and information within the diary was used for outcome measurement.
reduction of number of migraine days (by diary log)
时间窗: week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0)
Patients were followed per 2 weeks at the Headache Clinic. At each visit, diaries were collected, and information within the diary was used for outcome measurement.
次要结局
- fifty percent responder rate (by diary log)(week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0))
- reduction of number of days of acute abortive medication intake (by diary log)(week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0))
- reduction of number of acute abortive medication tablets taken (by diary log)(week 7 to 8 after treatment (T4) compared to week -2 to 0 before treatment (T0))
研究者
vghtpe user
Deputy Head, Neurological Institute
Taipei Veterans General Hospital, Taiwan