Clinical trial NCT03941834: Trial for Treatment Refractory Trigeminal Neuralgia
Official title: BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Trigeminal Neuralgia
Keywords: Trigeminal Neuralgia, Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 criteria: 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/m²
14. History of gallstones or cholecystectomy

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase
timeFrame: DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks)
measure: Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase
timeFrame: DBT Phase: Baseline, 2 Weeks Treatment
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: DBT Phase
timeFrame: DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: DBT Phase
timeFrame: DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks)
measure: Change From Baseline in Penn Facial Pain Scale-Revised (Penn-FPS-R) Total Score at 2 Week Treatment Phase: DBT Phase
timeFrame: DBT Phase: Baseline, 2 Weeks Treatment
measure: Change From Baseline in Pain Disability Index Total Score at 2 Week Treatment Phase: DBT Phase
timeFrame: DBT Phase: Baseline, 2 Weeks Treatment
measure: Patient Global Impression of Change Scale (PGI-C) Score at 2 Week Treatment Phase: DBT Phase
timeFrame: DBT Phase: Baseline, 2 Weeks Treatment
measure: Change From Baseline in Average Worst Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase
timeFrame: DBT Phase: Baseline, 2 Weeks Treatment
measure: Percentage of Participants With >= 2 Point Reduction From Baseline in Average Daily Pain Score on NPRS at 2 Week Treatment Phase: DBT Phase
timeFrame: DBT Phase: Baseline, 2 Weeks Treatment
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Gilbert Neurology Partners, PLLC/CCT Research
state: Arizona
city: La Jolla
country: United States
facility: Center for Neurohealth DBA Kaizen Brain Center
state: California
city: Palo Alto
country: United States
facility: Imaging Clinic at Stanford Neuroscience Health Center
state: California
city: Palo Alto
country: United States
facility: Stanford Hoover Pavilion
state: California
city: Palo Alto
country: United States
facility: Stanford Neuroscience Health Center- SNHC Pharmacy
state: California
city: Palo Alto
country: United States
facility: Stanford Neuroscience Health Center
state: California
city: Stanford
country: United States
facility: Stanford University- CAM Building
state: California
city: Miami
country: United States
facility: SouthCoast Research Center
state: Florida
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Clinical Outpatient Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins ICTR Clinical Research Unit (CRU)
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Lake Success
country: United States
facility: Neurological Surgery Practice of Long Island PLCC
state: New York
city: Lake Success
country: United States
facility: Neurological Surgery
state: New York
city: Lake Success
country: United States
facility: Premier Cardiolog Consultants
state: New York
city: New Hyde Park
country: United States
facility: Premier Cardiolog Consultants
state: New York
city: New Hyde Park
country: United States
facility: Premier Cardiology Consultants
state: New York
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology, PC
state: New York
city: Dayton
country: United States
facility: Neurology Diagnostics Inc.
state: Ohio
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: