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一项关于研究药物NURTEC® ODT 75 mg在韩国上市后的研究 (Rimegepant PMS)

2026年9月23日 更新者：Pfizer

一项评估NURTEC® ODT 75毫克（硫酸利美吉泮）在韩国成人偏头痛患者中的安全性和有效性的上市后监测（PMS）研究。

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).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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".

  1. Serious adverse event/adverse drug reaction
  2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
  3. Known adverse drug reaction
  4. Non-serious adverse drug reaction
  5. 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.

研究类型

观察性的

注册 (估计的)

3000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

At least 3000 subjects who are eligible for NURTEC® accoding to its product label will be enrolled by continuous registration method and will be researched under routine clinical setting of Korea.

描述

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Subjects aged 19 years or older
  2. Subjects who administered NURTEC® ODT 75 mg (Rimegepant sulfate) according to the approved label
  3. 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：CASE_ONLY
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
硫酸利美吉泮
药品：Rimegepant sulfate

ALL Who treated with Rimegepant sulfate

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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.
大体时间：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
28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)
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.
大体时间：28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

Serious Adverse Events (SAEs) Unit of Measure : Number of participants with SAEs
28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)
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.
大体时间：28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

Expected Adverse Events (Expected AEs) Unit of Measure : Number of participants with Expected AEs
28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)
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.
大体时间：28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

Adverse Drug Reactions (ADRs) Unit of Measure : Number of participants with ADRs
28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)
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.
大体时间：28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

Serious Adverse Drug Reactions (SADRs) Unit of Measure : Number of participants with SADRs
28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)
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.
大体时间：28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

Unexpected Adverse Events (Unexpected AEs) Unit of Measure : Number of participants with Unexpected AEs
28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)
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.
大体时间：28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

Expected Adverse Drug Reactions (Expected ADRs) Unit of Measure : Number of participants with Expected ADRs
28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)
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.
大体时间：28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

Unexpected Adverse Drug Reactions (Unexpected ADRs) Unit of Measure : Number of participants with Unexpected ADRs
28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

次要结果测量

结果测量
措施说明
大体时间
Acute Treatment Effectiveness : Pain Free at 2 Hours
大体时间：2 hours post-dose

Percentage of subjects who are pain-free at 2 hours post-dose for the treatment of an acute migraine attack.

Unit of Measure: Percentage of participants (%)
2 hours post-dose
Preventive Treatment Effectiveness : Change in Monthly Migraine Days (MMDs)
大体时间：Baseline, 3 months, 6 months

Mean change from baseline in the number of Monthly Migraine Days (MMDs). Unit of Measure: Days
Baseline, 3 months, 6 months
Preventive Treatment Effectiveness : Responder Rate (≥ 50% & ≥ 75%)
大体时间：3 months, 6 months

Percentage of subjects who achieve a ≥50% & ≥ 75% reduction from baseline in MMDs.

Unit of Measure: Percentage of participants (%)
3 months, 6 months
Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment)
大体时间：3 months, 6 months

Total score of the MIDAS questionnaire to assess headache-related disability. Unit of Measure: Score (points)
3 months, 6 months
Preventive Treatment Effectiveness : HIT-6 (Headache Impact Test-6)
大体时间：3 months, 6 months

Total score of the HIT-6 questionnaire to measure the impact of headaches on daily life.

Unit of Measure: Score (points
3 months, 6 months
Acute & Preventive Treatment Effectiveness
大体时间：24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal)

The percentage of subjects categorized as 'Improved' based on the investigator's clinical judgment and/or laboratory test results. Overall effectiveness is evaluated across four categories (Improved, Unchanged, Aggravated, Not assessed), with 'Improved' cases being used to calculate the final effectiveness rate.

  • Improved: Symptoms are deemed to be improved or maintained (including cases where the effect of a previous drug is maintained after switching to NURTEC® ODT).
  • Unchanged: Symptoms show no improvement compared to baseline, nor is there a maintenance effect.
  • Aggravated: Symptoms have worsened compared to baseline.
  • Not assessed: Effectiveness results are not available.

Unit of Measure: Percentage of participants (%)
24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年3月1日

初级完成 (估计的)

2030年7月31日

研究完成 (估计的)

2030年8月1日

研究注册日期

首次提交

2026年2月28日

首先提交符合 QC 标准的

2026年3月23日

首次发布 (实际的)

2026年3月27日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C4951028

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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