NCT07497854

Brief Summary

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Oct 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

February 28, 2026

Last Update Submit

March 23, 2026

Conditions

Migraine With or Without Aura

Keywords

Rimegepant sulfatesafetyefficacy

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (6)

  • Acute Treatment Effectiveness : Pain Free at 2 Hours

    2 hours post-dose

  • Preventive Treatment Effectiveness : Change in Monthly Migraine Days (MMDs)

    Baseline, 3 months, 6 months

  • Preventive Treatment Effectiveness : Responder Rate (≥ 50% & ≥ 75%)

    3 months, 6 months

  • Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment)

    3 months, 6 months

  • Preventive Treatment Effectiveness : HIT-6 (Headache Impact Test-6)

    3 months, 6 months

  • +1 more secondary outcomes

Study Arms (1)

Rimegepant sulfate

Drug: Rimegepant sulfate

Interventions

Rimegepant sulfateDRUG

ALL Who treated with Rimegepant sulfate

Rimegepant sulfate

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

rimegepant sulfate

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2026

First Posted

March 27, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.