Studie zaměřená na studium léčiva NURTEC® ODT 75 mg po jeho uvedení na trh v Koreji (Rimegepant PMS)
Postmarketingová sledovací (PMS) studie pro vyhodnocení bezpečnosti a účinnosti přípravku NURTEC® ODT 75 mg (síran rimegepantu) u dospělých pacientů s migrénou v Koreji.
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).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Pfizer CT.gov Call Center
- Telefonní číslo: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_ONLY
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Rimegepant sulfát
|
ALL Who treated with Rimegepant sulfate |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Acute Treatment Effectiveness : Pain Free at 2 Hours
Časové okno: 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)
Časové okno: 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%)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C4951028
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .