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).
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.
None
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.
Case-only
Prospective
Rimegepant sulfate
DrugALL Who treated with 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.
All adverse events (AEs) Unit of Measure: Number of participants with AEs
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
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
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
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 (%)
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
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 (%)
Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment)
Total score of the MIDAS questionnaire to assess headache-related disability. Unit of Measure: Score (points)
This trial is not recruiting at the moment. You can still explore other options:
