Uno studio per conoscere il farmaco dello studio NURTEC® ODT 75 mg dopo la sua immissione sul mercato in Corea (Rimegepant PMS)
Uno studio di sorveglianza post-marketing (PMS) per valutare la sicurezza e l'efficacia di NURTEC® ODT 75 mg (solfato di rimegepant) in pazienti adulti con emicrania in Corea.
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Pfizer CT.gov Call Center
- Numero di telefono: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: CASE_ONLY
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Solfato di rimegepant
|
ALL Who treated with Rimegepant sulfate |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Acute Treatment Effectiveness : Pain Free at 2 Hours
Lasso di tempo: 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)
Lasso di tempo: 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%)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C4951028
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .