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

Pfizer

Status: Begins enrollment in 4 months

Conditions: Migraine With or Without Aura

Treatments: Drug: Rimegepant sulfate

Study type: Observational

Funder types: Industry

Identifiers

NCT07497854

Rimegepant PMS (Other Identifier)

C4951028

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

3,000 participants in 1 patient group

Rimegepant sulfate

Treatment:

Drug: Rimegepant sulfate