Rimegepant para la prevención de la migraña en pacientes japoneses

Rimegepant

Placebo

Mean Change From Baseline in Number of Migraine Days Per Month From Week 9 to 12 of the Double-Blind Treatment (DBT) Phase

Percentage of Participants With at Least 50% Reduction From Baseline in the Mean Number of Moderate to Severe Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase

Mean Change From Baseline in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)

Mean Change From Baseline in Number of Migraine Days Per Month From Week 1 to 4 of the DBT Phase

Mean Number of Acute Migraine-specific Medication Days Per Month From Week 9 to 12 of the DBT Phase

Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) v 2.1 Role Function - Restrictive Domain Score at Week 12 of the DBT Phase

Mean Change From Baseline in the Migraine Disability Assessment Total Score (MIDAS) at Week 12 of the DBT Phase

Mean Change From Baseline in the EuroQol 5 Dimensions 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Week 12 of the DBT Phase

Number of Participants With Adverse Events (AEs) By Intensity in DBT Phase

Number of Participants With AEs By Intensity in Open-Label Extension (OLE) Phase

Number of Participants With Serious Adverse Events (SAEs) in DBT Phase

Number of Participants With Hepatic-related AEs in the DBT Phase

Number of Participants With Hepatic-related AEs in the OLE Phase

Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation in the DBT Phase

Number of Participants With SAEs in OLE Phase

Number of Participants With AEs Leading to Discontinuation of Study Drug in DBT Phase

Number of Participants With AEs Leading to Discontinuation of Study Drug in OLE Phase

Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Hematology Parameters

Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase: Hematology Parameters

Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase: Serum Chemistry Parameters

Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase: Serum Chemistry Parameters

Number of Participants With Grade 3 to 4 Changes in DBT Phase: Urinalysis

Number of Participants With Grade 3 to 4 Changes in OLE Phase: Urinalysis

Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3* Upper Lower Limit of Normal (ULN) Concurrent With Total Bilirubin (TBIL) >2*ULN in DBT Phase

Number of Participants With ALT or AST> 3* ULN Concurrent With TBIL >2* ULN in OLE Phase

Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation in the OLE Phase