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En studie för att lära sig om studiemedicinen NURTEC® ODT 75 mg efter dess lansering på marknaderna i Sydkorea (Rimegepant PMS)

23 september 2026 uppdaterad av: Pfizer

En postmarknadssurveillance (PMS)-studie för att utvärdera säkerheten och effektiviteten av NURTEC® ODT 75 mg (Rimegepant Sulfate) hos vuxna migränpatienter i Sydkorea.

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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

3000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

19 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: CASE_ONLY
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Rimegepantsulfat
Läkemedel: Rimegepant sulfate

ALL Who treated with Rimegepant sulfate

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acute Treatment Effectiveness : Pain Free at 2 Hours
Tidsram: 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)
Tidsram: 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%)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Utredare

  • Studierektor: Pfizer CT.gov Call Center, Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 mars 2027

Primärt slutförande (Beräknad)

31 juli 2030

Avslutad studie (Beräknad)

1 augusti 2030

Studieregistreringsdatum

Först inskickad

28 februari 2026

Först inskickad som uppfyllde QC-kriterierna

23 mars 2026

Första postat (Faktisk)

27 mars 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C4951028

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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