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Trial for Treatment Refractory Trigeminal Neuralgia

July 24, 2019

Overview

 

The Trial for Treatment Refractory Trigeminal Neuralgia studies the efficacy of the drug BHV3000 for patients with Trigeminal Neuralgia. The study uses a placebo to judge the effects based on a 2+ point reduction in the Numeric Pain Rating Scale. The patients’ pain scale is measured at the end of each two week treatment phase.

 

Study Information

 

Patients are given a 75mg tablet of BHV3000 (Rimegepant) or a placebo. The timeline from baseline to end of randomization phase is up to 5 weeks. The study aims to improve physical function, reduce pain, improve emotional function, improve global function, improve functional disability, and measure the safety of the drug.

 

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 3 months before screening visit.
  • Neuroimaging to exclude causes for the neuralgia other than neurovascular compression.

 

Exclusion Criteria

 

  • Structural lesion on neuroimaging – other than vascular compression of the trigeminal nerve or nerve root that would explain the neuralgia
  • Neurologic deficit on neurologic exam
  • History of HIV
  • 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)
  • 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
  • History of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that causes malabsorption
  • History or diagnosis of Gilbert’s Syndrome or any other active hepatic or biliary disorder
  • 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 >30kg/m²

 

Location

 

Johns Hopkins University

Baltimore, Maryland, United States, 21287

 

Sponsors/Collaborators

 

Biohaven Pharmaceuticals, Inc.

 

Contact: Robert Berman, MD: (203) 404-0410

clinicaltrials@biohavenpharma.com

Contact: Jessica Wollett: (410) 502-7752

Jwollet1@jhmi.edu

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