A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea (Rimegepant PMS)

A Post-marketing Surveillance (PMS) Study to Evaluate the Safety and Effectiveness of NURTEC® ODT 75 mg (Rimegepant Sulfate) in Adult Migraine Patients 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine With or Without Aura
• Intervention / Treatment: Drug: Rimegepant sulfate

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rimegepant sulfate	Drug: Rimegepant sulfate; ALL Who treated with Rimegepant sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Treatment Effectiveness : Pain Free at 2 Hours	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)	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%)	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)	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)	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	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: February 28, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: safety; efficacy; Rimegepant sulfate
• Additional Relevant MeSH Terms: rimegepant sulfate
• Other Study ID Numbers: C4951028; Rimegepant PMS (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No