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Trial for Treatment Refractory Trigeminal Neuralgia | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Trial for Treatment Refractory Trigeminal Neuralgia

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

NCT03941834•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (20)

Gilbert Neurology Partners, PLLC/CCT Research

Gilbert, Arizona, United States

Center for Neurohealth DBA Kaizen Brain Center

La Jolla, California, United States

Imaging Clinic at Stanford Neuroscience Health Center

Palo Alto, California, United States

Stanford Hoover Pavilion

Palo Alto, California, United States

Stanford Neuroscience Health Center- SNHC Pharmacy

Palo Alto, California, United States

Stanford Neuroscience Health Center

Palo Alto, California, United States

Stanford University- CAM Building

Stanford, California, United States

SouthCoast Research Center

Miami, Florida, United States

Ochsner Baptist Medical Center

New Orleans, Louisiana, United States

Johns Hopkins Clinical Outpatient Center

Baltimore, Maryland, United States

Key Dates

Start Date

June 25, 2019

Primary Completion Date

May 11, 2023

Completion Date

May 11, 2023

Last Updated

June 10, 2024

Enrollment

ACTUAL participants

Conditions

Trigeminal Neuralgia

Interventions

Rimegepant

DRUG

Placebo

DRUG

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells Exosomes for Trigeminal Neuralgia

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Peripheral NeuropathyTrigeminal Neuralgia

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RECRUITINGNA

Impact of Individual Radiosensitivity on Late Toxicities of Radiosurgery in Essential Trigeminal Neuralgia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial for Treatment Refractory Trigeminal Neuralgia

Inclusion Criteria

Exclusion Criteria

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells Exosomes for Trigeminal Neuralgia

Impact of Individual Radiosensitivity on Late Toxicities of Radiosurgery in Essential Trigeminal Neuralgia

Neurosurgical Outcome Network

Sphenopalatine Ganglion Pulsed Radiofrequency Treatment Outcomes

Risk Factors for Recurrence of Trigeminal Neuralgia After Percutaneous Balloon Compression

Sphenopalatine Ganglion Block with Tx360 for Trigeminal Neuralgia