Badanie dotyczące poznania leku badawczego NURTEC® ODT 75 mg po jego wprowadzeniu na rynek w Korei (Rimegepant PMS)
Badanie porejestracyjnego nadzoru nad bezpieczeństwem stosowania (PMS) oceniające bezpieczeństwo i skuteczność preparatu NURTEC® ODT 75 mg (siarczan rimegepantu) u dorosłych pacjentów z migreną w Korei.
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).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Pfizer CT.gov Call Center
- Numer telefonu: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: CASE_ONLY
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Siarczan rimegepantu
|
ALL Who treated with Rimegepant sulfate |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Acute Treatment Effectiveness : Pain Free at 2 Hours
Ramy czasowe: 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)
Ramy czasowe: 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%)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Pfizer CT.gov Call Center, Pfizer
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- C4951028
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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