A Post-marketing Surveillance (PMS) Study to Evaluate the Safety and Effectiveness of NURTEC® ODT 75 mg (Rimegepant Sulfate) in Adult Migraine Patients in Korea.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 3,000
- 主要终点
- To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine.
研究概览
简要总结
The purpose of this study is to evaluate safety and effectiveness of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine during the PMS period as required by the Korean ministry of food and drug safety (MFDS).
详细描述
The objective of this study is to determine any problems or questions associated with NURTEC® after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination Guideline of New Drugs".
- Serious adverse event/adverse drug reaction
- Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
- Known adverse drug reaction
- Non-serious adverse drug reaction
- Other safety and effectiveness information As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug. This reserach shall begin after approval of marketing in Korea by MFDS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to be eligible for inclusion in the study:
- •Subjects aged 19 years or older
- •Subjects who administered NURTEC® ODT 75 mg (Rimegepant sulfate) according to the approved label
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- 未提供
研究组 & 干预措施
Rimegepant sulfate
干预措施: Rimegepant sulfate (Drug)
结局指标
主要结局
To evaluate the safety of NURTEC® ODT 75 mg (Rimegepant sulfate) in adult patients with acute treatment of migraine with or without aura and with preventive treatment of episodic migraine.
时间窗: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)
All adverse events (AEs) Unit of Measure: Number of participants with AEs
次要结局
- Acute Treatment Effectiveness : Pain Free at 2 Hours(2 hours post-dose)
- Preventive Treatment Effectiveness : Change in Monthly Migraine Days (MMDs)(Baseline, 3 months, 6 months)
- Preventive Treatment Effectiveness : Responder Rate (≥ 50% & ≥ 75%)(3 months, 6 months)
- Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment)(3 months, 6 months)
- Preventive Treatment Effectiveness : HIT-6 (Headache Impact Test-6)(3 months, 6 months)
- Acute & Preventive Treatment Effectiveness(24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal))