A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea

Официальное название

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.

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Rimegepant sulfate
  ALL Who treated with Rimegepant sulfate

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)]

Вторичные конечные точки (6)

• Acute Treatment Effectiveness : Pain Free at 2 Hours [Срок оценки: 2 hours post-dose]
• Preventive Treatment Effectiveness : Change in Monthly Migraine Days (MMDs) [Срок оценки: Baseline, 3 months, 6 months]
• Preventive Treatment Effectiveness : Responder Rate (≥ 50% & ≥ 75%) [Срок оценки: 3 months, 6 months]
• Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment) [Срок оценки: 3 months, 6 months]
• Preventive Treatment Effectiveness : HIT-6 (Headache Impact Test-6) [Срок оценки: 3 months, 6 months]
• Acute & Preventive Treatment Effectiveness [Срок оценки: 24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07497854 · C4951028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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