Eine Studie zur Untersuchung des Studienmedikaments NURTEC® ODT 75 mg nach seiner Markteinführung in Korea (Rimegepant PMS)
Eine Post-Marketing-Überwachungsstudie (PMS) zur Bewertung der Sicherheit und Wirksamkeit von NURTEC® ODT 75 mg (Rimegepant-Sulfat) bei erwachsenen Migränepatienten in Korea.
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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_ONLY
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Rimegepant-Sulfat
|
ALL Who treated with Rimegepant sulfate |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Acute Treatment Effectiveness : Pain Free at 2 Hours
Zeitfenster: 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)
Zeitfenster: 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%)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Pfizer CT.gov Call Center, Pfizer
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- C4951028
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
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