Migraine With or Without Aura
Conditions
Keywords
Rimegepant sulfate, safety, efficacy
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).
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
ALL Who treated with Rimegepant sulfate
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) | All adverse events (AEs) Unit of Measure: Number of participants with AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Treatment Effectiveness : Pain Free at 2 Hours | 2 hours post-dose | 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) | Baseline, 3 months, 6 months | Mean change from baseline in the number of Monthly Migraine Days (MMDs). Unit of Measure: Days |
| Preventive Treatment Effectiveness : Responder Rate (≥ 50% & ≥ 75%) | 3 months, 6 months | 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) | 3 months, 6 months | Total score of the MIDAS questionnaire to assess headache-related disability. Unit of Measure: Score (points) |
| Preventive Treatment Effectiveness : HIT-6 (Headache Impact Test-6) | 3 months, 6 months | Total score of the HIT-6 questionnaire to measure the impact of headaches on daily life. Unit of Measure: Score (points |
| Acute & Preventive Treatment Effectiveness | 24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal) | 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 (%) |
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed