BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuraligia

  • STATUS
    Recruiting
  • End date
    May 4, 2023
  • participants needed
    60
  • sponsor
    Biohaven Pharmaceuticals, Inc.
Updated on 23 October 2022
headache
ache
rimegepant

Summary

The purpose of this study is to evaluate the efficacy of BHV3000 compared to placebo for subjects with treatment refractory Trigeminal Neuralgia as measured by a 2-point or greater reduction in the average Numeric Pain Rating Scale between the two-week treatment phases.

Details
Condition Trigeminal Neuralgia
Treatment Placebo, Rimegepant
Clinical Study IdentifierNCT03941834
SponsorBiohaven Pharmaceuticals, Inc.
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects with a clinical diagnosis of typical or atypical classical trigeminal neuralgia based on the International Classification of Headache Disorders, 3rd edition, beta version
Trigeminal neuralgia symptoms for a minimum of 8 weeks prior to randomization visit
Neuroimaging to exclude another cause for the neuralgia, other than neurovascular compression

Exclusion Criteria

Subject has a structural lesion on neuroimaging, other than vascular compression of the trigeminal nerve or nerve root that would explain the neuralgia
Subject has a clinically evident neurologic deficit on neurologic exam of the cranial nerves
Subjects 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) at screening
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 a disease that causes malabsorption
Subject has a history or diagnosis of Gilbert's Syndrome or any other active hepatic or biliary disorder
The subject has a history or current 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
Hematologic or solid malignancy diagnosis within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit in this study
Hematologic or solid malignancy diagnosis within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit in this study
Body mass index >33kg/m²
History of gallstones or cholecystectomy
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