Trial for Treatment Refractory Trigeminal Neuralgia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Trigeminal Neuralgia

In brief

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.

Key facts

Study ID

NCT03941834

Run by

Pfizer

People needed

65

Starts

2019-06-25

Expected to finish

2023-05-11

Last updated by the study team

2024-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Johns Hopkins ICTR Clinical Research Unit (CRU) — Baltimore, Maryland, United States
• Clinical Research Professionals — Chesterfield, Missouri, United States
• Dent Neurosciences Research Center — Amherst, New York, United States
• Neurological Surgery Practice of Long Island PLCC — Lake Success, New York, United States
• Neurological Surgery — Lake Success, New York, United States
• Premier Cardiolog Consultants — Lake Success, New York, United States
• Premier Cardiolog Consultants — New Hyde Park, New York, United States
• Premier Cardiology Consultants — New Hyde Park, New York, United States
• North Suffolk Neurology, PC — Port Jefferson Station, New York, United States
• Neurology Diagnostics Inc. — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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