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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).
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant sulfate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant sulfate | Drug | ALL Who treated with Rimegepant sulfate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Serious Adverse Events (SAEs) Unit of Measure : Number of participants with SAEs | 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. | Expected Adverse Events (Expected AEs) Unit of Measure : Number of participants with Expected AEs | 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. | Adverse Drug Reactions (ADRs) Unit of Measure : Number of participants with ADRs | 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. | Serious Adverse Drug Reactions (SADRs) Unit of Measure : Number of participants with SADRs |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) | 2 hours post-dose |
| Preventive Treatment Effectiveness : Change in Monthly Migraine Days (MMDs) |
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Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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| 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. | Unexpected Adverse Events (Unexpected AEs) Unit of Measure : Number of participants with Unexpected AEs | 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. | Expected Adverse Drug Reactions (Expected ADRs) Unit of Measure : Number of participants with Expected ADRs | 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. | Unexpected Adverse Drug Reactions (Unexpected ADRs) Unit of Measure : Number of participants with Unexpected ADRs | 28 days after from last administration of NURTEC® ODT 75 mg (Rimegepant sulfate) |
Mean change from baseline in the number of Monthly Migraine Days (MMDs). Unit of Measure: Days |
| Baseline, 3 months, 6 months |
| 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 (%) | 3 months, 6 months |
| Preventive Treatment Effectiveness : MIDAS (Migraine Disability Assessment) | Total score of the MIDAS questionnaire to assess headache-related disability. Unit of Measure: Score (points) | 3 months, 6 months |
| 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 | 3 months, 6 months |
| 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.
Unit of Measure: Percentage of participants (%) | 24 weeks (at the completion of follow-up or at the time of treatment discontinuation/withdrawal) |