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Migraine With or Without AuraRimegepant PMSNCT07497854

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

An observational study of Migraine With or Without Aura, run by Pfizer.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Migraine With or Without Aura
What is being tested?
Rimegepant sulfate
How many people
3,000 participants
Where
No sites listed yet
Study dates
1 Mar 2027to 1 Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

About this study

Official title: 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).

Read the 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.
Being tested
Rimegepant sulfate
Keywords
Rimegepant sulfate, safety, efficacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rimegepant sulfateDrug

    ALL Who treated with Rimegepant sulfate

Study groups in NCT07497854
Study groupRoleWhat they receive
Rimegepant sulfateNot described
Receives: Drug: Rimegepant sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

  2. 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

    Measured: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

  3. 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

    Measured: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

  4. 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

    Measured: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

  5. 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

    Measured: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

  6. 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

    Measured: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

  7. 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

    Measured: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

  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.

    Unexpected Adverse Drug Reactions (Unexpected ADRs) Unit of Measure : Number of participants with Unexpected ADRs

    Measured: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)

Secondary outcomes (6)

  1. 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 (%)

    Measured: 2 hours post-dose

  2. 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

    Measured: Baseline, 3 months, 6 months

  3. 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 (%)

    Measured: 3 months, 6 months

  4. Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment)

    Total score of the MIDAS questionnaire to assess headache-related disability. Unit of Measure: Score (points)

    Measured: 3 months, 6 months

  5. 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

    Measured: 3 months, 6 months

  6. 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 (%)

    Measured: 24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start1 Mar 2027 (estimated)
  3. Primary completion31 Jul 2030 (estimated)
  4. Study completion1 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07497854
Sponsor's protocol ID
C4951028
Acronym
Rimegepant PMS
Status last verified
Sep 2026
First submitted
28 Feb 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine With or Without Aura, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07497854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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