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En undersøgelse af lægemidlet NURTEC® ODT 75 mg efter dets markedsføring i Korea (Rimegepant PMS)

23. september 2026 opdateret af: Pfizer

En post-markedsføringsovervågningsstudie (PMS) til evaluering af sikkerhed og effektivitet af NURTEC® ODT 75 mg (Rimegepantsulfat) hos voksne migrænepatienter i 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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

3000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Subjects aged 19 years or older
  2. Subjects who administered NURTEC® ODT 75 mg (Rimegepant sulfate) according to the approved label
  3. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: CASE_ONLY
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Rimegepant sulfat
Medicin: Rimegepant sulfate

ALL Who treated with Rimegepant sulfate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute Treatment Effectiveness : Pain Free at 2 Hours
Tidsramme: 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)
Tidsramme: 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%)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

  • Improved: Symptoms are deemed to be improved or maintained (including cases where the effect of a previous drug is maintained after switching to NURTEC® ODT).
  • Unchanged: Symptoms show no improvement compared to baseline, nor is there a maintenance effect.
  • Aggravated: Symptoms have worsened compared to baseline.
  • Not assessed: Effectiveness results are not available.

Unit of Measure: Percentage of participants (%)
24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. marts 2027

Primær færdiggørelse (Anslået)

31. juli 2030

Studieafslutning (Anslået)

1. august 2030

Datoer for studieregistrering

Først indsendt

28. februar 2026

Først indsendt, der opfyldte QC-kriterier

23. marts 2026

Først opslået (Faktiske)

27. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C4951028

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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