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Not yet recruiting NCT07497854

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

— Observational Migraine With or Without Aura

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rimegepant sulfate.
Who it may be relevant to
Registry conditions: Migraine With or Without Aura. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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).

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.

Interventions

  • Drug Rimegepant sulfate
    ALL Who treated with Rimegepant sulfate

Primary outcome measures

  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
Secondary outcome measures (6)
  • Acute Treatment Effectiveness : Pain Free at 2 Hours [Time frame: 2 hours post-dose]
  • Preventive Treatment Effectiveness : Change in Monthly Migraine Days (MMDs) [Time frame: Baseline, 3 months, 6 months]
  • Preventive Treatment Effectiveness : Responder Rate (≥ 50% & ≥ 75%) [Time frame: 3 months, 6 months]
  • Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment) [Time frame: 3 months, 6 months]
  • Preventive Treatment Effectiveness : HIT-6 (Headache Impact Test-6) [Time frame: 3 months, 6 months]
  • Acute & Preventive Treatment Effectiveness [Time frame: 24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07497854 · C4951028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗