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Phase 3 N=1,466 Randomized Triple-blind Treatment

Trial in Adult Subjects With Acute Migraines

Migraine, With or Without Aura

Enrolled (actual)
1,466
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Percentage of Participants With Freedom From Pain at 2 Hours Post-dose — 21.2; 10.9 percentage of participants — p=< 0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Rimegepant (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Pfizer
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
21.2; 10.9 < 0.0001 sig
PRIMARY
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
35.1; 26.8 0.0009 sig
SECONDARY
Percentage of Participants With Pain Relief at 2 Hours Post-dose
59.3; 43.3 < 0.0001 sig
SECONDARY
Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose
38.1; 25.8 < 0.0001 sig
SECONDARY
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
47.8; 27.7 < 0.0001 sig
SECONDARY
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose
27.1; 17.7 < 0.0001 sig
SECONDARY
Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose
14.2; 29.2 < 0.0001 sig
SECONDARY
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose
29.6; 16.9 < 0.0001 sig
SECONDARY
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
42.2; 25.2 < 0.0001 sig
SECONDARY
Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose
23.2; 16.4 0.0018 sig
SECONDARY
Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose
26.0; 15.4 < 0.0001 sig
SECONDARY
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
33.4; 24.5 0.0007 sig
SECONDARY
Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose
30.2; 21.3 0.0002 sig
SECONDARY
Percentage of Participants With Pain Relief at 90 Minutes Post-dose
49.6; 37.2 < 0.0001 sig
SECONDARY
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
15.7; 5.6 < 0.0001 sig
SECONDARY
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose
27.4; 21.5 0.0128 sig
SECONDARY
Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose
15.1; 7.3 < 0.0001 sig
SECONDARY
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
41.7; 30.2 0.0003 sig
SECONDARY
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
13.5; 5.4 < 0.0001 sig
SECONDARY
Percentage of Participants With Pain Relief at 60 Minutes Post-dose
36.8; 31.2 0.0314 sig
SECONDARY
Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose
22.3; 15.8 0.0025 sig
SECONDARY
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
51.0; 45.2 0.0898
SECONDARY
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose
36.6; 50.0

Summary

The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.

Eligibility Criteria

Key Inclusion Criteria

  • Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version [1] including the following:
  • Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
  • Migraine attacks, on average, lasting about 4-72 hours if untreated
  • Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
  • Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period
  • Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.
  • Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study.
  • Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria

  • Subject with a history of HIV disease
  • Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
  • Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
  • Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
  • Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
  • The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
  • History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
  • Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.
  • Participation in any other investigational clinical trial while participating in this clinical trial
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03461757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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