韓国市場への発売後における研究薬NURTEC® ODT 75 mgに関する研究 (Rimegepant PMS)
韓国における成人片頭痛患者を対象としたNURTEC® ODT 75 mg（リメジェパント硫酸塩）の安全性と有効性を評価するための市販後調査（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).
調査の概要
詳細な説明
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".
- 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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Pfizer CT.gov Call Center
- 電話番号：1-800-718-1021
- メール：ClinicalTrials.gov_Inquiries@pfizer.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
Patients must meet all of the following inclusion criteria 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
硫酸リメゲパント
|
ALL Who treated with Rimegepant sulfate |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute Treatment Effectiveness : Pain Free at 2 Hours
時間枠：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)
時間枠：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%)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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.
Unit of Measure: Percentage of participants (%) |
24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Pfizer CT.gov Call Center、Pfizer
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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