A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Overview
- Phase
- Phase 4
- Intervention
- Rimegepant 75mg daily dosing
- Conditions
- Migraine
- Sponsor
- Pfizer
- Enrollment
- 1415
- Locations
- 106
- Primary Endpoint
- Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- •Age of onset of migraines prior to 50 years of age
- •Migraine attacks, on average, lasting 4-72 hours if untreated
- •Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol
Exclusion Criteria
- •Sex and Reproductive Status:
- •WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
- •Women who are pregnant or breastfeeding
- •Women with a positive pregnancy test at screening or prior to study drug administration
- •Prohibited Medications:
- •Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
- •History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
- •Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
- •Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
- •Subjects taking a prohibited medication as defined per protocol
Arms & Interventions
Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing
Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily
Intervention: Rimegepant 75mg daily dosing
Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing
Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
Intervention: Rimegepant 75mg every other day dosing
Placebo comparator dosing
Double-blind Treatment Phase: matching placebo dosed daily
Intervention: Placebo comparator dosing
Outcomes
Primary Outcomes
Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)
Time Frame: Observation phase (from 31 days prior to randomization), DBT phase (through Month 3 [Week 1 to 12])
A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for \>=30 minutes, and meeting either \>=2 of the pain features: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by or causing avoidance of routine physical activity OR \>=1 of the associated symptoms: nausea and/or vomiting; photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for a month in on-DBT efficacy analysis period as follows: 28\*(total number of migraine days through Month 3 \[Weeks 1 to 12\]/ (total number of e-diary efficacy data days through Month 3 \[Weeks 1 to 12\]). Mean change in number of migraine days per month in DBT phase as compared to OP phase was calculated and reported in this outcome measure.
Secondary Outcomes
- Percentage of Participants With Greater Than Equal to (>=) 50 Percent (%) Reduction From OP in Number of Moderate to Severe Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)(DBT phase (through Month 3 [Week 1 to 12]))
- Mean Change From OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase(Observation phase (from 31 days before randomization), Week 9 to Week 12 of the DBT phase)
- Mean Change From OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase(Observation phase (from 31 days before randomization), Week 1 to Week 4 of the DBT phase)
- Mean Number of Acute Migraine-Specific Medication Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)(DBT phase (through Month 3 [Week 1 to 12]))
- Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) Version 2.1 Restrictive Role Function Domain Score at Week 12 of the DBT Phase(Baseline (Day 1), Week 12 of the DBT phase)
- Number of Participants With Mild, Moderate and Severe Adverse Events (AEs) in DBT Phase(DBT: From Week 1 to Week 20)
- Number of Participants With Mild, Moderate and Severe AEs OLE Phase(OLE: From Week 12 to Week 32)
- Number of Participants With Serious Adverse Events (SAEs) in DBT Phase(DBT: From Week 1 to Week 20)
- Number of Participants With SAEs in OLE Phase(OLE: From Week 12 to Week 32)
- Number of Participants With AEs Leading to Study Drug Discontinuation in DBT Phase(DBT: From Week 1 to Week 12)
- Number of Participants With AEs Leading to Study Drug Discontinuation in OLE Phase(OLE: From Week 12 to Week 24)
- Number of Participants With Grade 3 to 4 Laboratory Abnormalities in DBT Phase(DBT: From Week 1 to Week 20)
- Number of Participants With Grade 3 to 4 Laboratory Abnormalities in OLE Phase(OLE: From Week 12 to Week 32)
- Number of Participants With Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) Elevations > 3* Upper Limit of Normal (ULN) Concurrent With (Total Bilirubin) TBL >2*ULN in DBT Phase(DBT: From Week 1 to Week 20)
- Number of Participants With AST or ALT Elevations > 3* ULN Concurrent With TBL >2*ULN in OLE Phase(OLE: From Week 12 to Week 32)
- Number of Participants With Hepatic-Related AEs in the DBT Phase(DBT: From Week 1 to Week 20)
- Number of Participants With Hepatic-Related AEs in the OLE Phase(OLE: From Week 12 to Week 32)
- Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the DBT Phase(DBT: From Week 1 to Week 12)
- Number of Participants With Hepatic-Related AEs Leading to Study Drug Discontinuation in the OLE Phase(OLE: From Week 12 to Week 24)