Trial for Treatment Refractory Trigeminal Neuralgia
Stopped: Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
United States65 participantsStarted 2019-06-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
✕
What they're measuring
1
Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase
Timeframe: DBT Phase: Baseline (before dose on Day 1), 2 Weeks Treatment
. 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