Trial Search Results

Trial for Treatment Refractory Trigeminal Neuralgia

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Biohaven Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Rimegepant
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Subjects with a clinical diagnosis of typical or atypical classical trigeminal
   neuralgia based on the International Classification of Headache Disorders, 3rd
   edition, beta version.

   2. Trigeminal neuralgia symptoms for a minimum of 8 weeks prior to randomization visit.

   3. Neuroimaging to exclude another cause for the neuralgia, other than neurovascular
   compression.

Exclusion Criteria:

   1. Subject has a structural lesion on neuroimaging, other than vascular compression of
   the trigeminal nerve or nerve root that would explain the neuralgia

   2. Subject has a clinically evident neurologic deficit on neurologic exam of the cranial
   nerves

   3. Subjects with a history of HIV disease

   4. 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

   5. Uncontrolled hypertension (high blood pressure) at screening

   6. 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

   7. 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

   8. Subject has a history or diagnosis of Gilbert's Syndrome or any other active hepatic
   or biliary disorder

   9. 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

10. 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

11. 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.

12. 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.

13. Body mass index >33kg/m┬▓

14. History of gallstones or cholecystectomy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Anthony Bet
650-683-5823
Recruiting