A Continuous Treatment Study of JNS019 (Topiramate) in Migraine Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 296
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting and constipation or diarrhea) who completed the JNS019-JPN-02 study.
详细描述
This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than one center), dose-titration (dose escalation/reduction) study of topiramate in participants with migraine. This study is a continuous study for the participants who were enrolled in the JNS019-JPN-02 study. Participants who completed the JNS019-JPN-02 study will receive treatment for 52 weeks starting at Visit 4 of the JNS019-JPN-02 study. The present study will consist of 3 weeks of Transfer period (during this period the dose titration will take place and along with dose titration the new treatment will be initiated at 25 milligram per day [25mg/day]), Continuous treatment period (32 weeks), Exit period (up to 3 weeks) and Follow-up period (4 weeks). Participants in the Continuous treatment period will receive topiramate tablets orally in the dose range of 50 mg/day to 100 mg/day. Dose can be increased or decreased as per Investigator's discretion. The maximum daily dose will be 200 mg/day. Efficacy will be primarily evaluated by change from Baseline in the number of monthly migraine attacks in Continuous treatment period. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who completed the JNS019-JPN-02 study or discontinued the study at Week 4 or after in fixed-dose period because of insufficient efficacy
排除标准
- •Participants who discontinued the JNS019-JPN-02 study for an adverse event unrelated to the underlying disease
- •Participants judged unfavorable to be transferred to this study because of the safety assessments in the JNS019-JPN-02 study
- •Pregnant (carrying an unborn baby) female participants
- •Other participants who were considered ineligible as per Investigator's discretion
研究组 & 干预措施
Topiramate
干预措施: Topiramate (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Baseline up to 28 days after last dose of study drug
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
次要结局
- Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period(Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225))
- Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period(Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225))
- Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period(Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225))
- Change From Baseline in the Average Number of Migraine Attacks According to the Diagnostic Criteria of the International Headache Society Per Month in Continuous Treatment Period(Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225))
- Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period(Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225))
- Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period(Baseline (28 days before randomization) and Day 197 to Day 225)
- Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period(Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225))
- Percentage of Participants With Response to Treatment(Baseline (28 days before randomization) up to Day 225)
- Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score(Baseline (28 days before randomization) and FE (Day 225/early discontinuation))