Trial for Treatment Refractory Trigeminal Neuralgia

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Pfizer
Study ID
NCT03941834
Phase
PHASE2
Status
Terminated

Conditions

  • Trigeminal Neuralgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    BHV3000 (rimegepant) 75mg tablet
  • Placebo — DRUG
    Placebo

Study Details

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 Dates

Start date
Jun 25, 2019
Status verified
May 2024
Primary completion
May 11, 2023
Completion
May 11, 2023

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: BHV3000
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase [ Time Frame: DBT Phase: Baseline (before dose on Day 1), 2 Weeks Treatment ]

Locations (20)

FacilityCityStateZIPSite coordinators
Gilbert Neurology Partners, PLLC/CCT ResearchGilbertArizona85297-
Center for Neurohealth DBA Kaizen Brain CenterLa JollaCalifornia92037-
Imaging Clinic at Stanford Neuroscience Health CenterPalo AltoCalifornia94304-
Stanford Hoover PavilionPalo AltoCalifornia94304-
Stanford Neuroscience Health CenterPalo AltoCalifornia94304-
Stanford Neuroscience Health Center- SNHC PharmacyPalo AltoCalifornia94304-
Stanford University- CAM BuildingStanfordCalifornia94305-
SouthCoast Research CenterMiamiFlorida33136-
Ochsner Baptist Medical CenterNew OrleansLouisiana70115-
Johns Hopkins Clinical Outpatient CenterBaltimoreMaryland21287-
Johns Hopkins ICTR Clinical Research Unit (CRU)BaltimoreMaryland21287-
Clinical Research ProfessionalsChesterfieldMissouri63005-
Dent Neurosciences Research CenterAmherstNew York14226-
Neurological SurgeryLake SuccessNew York11042-
Neurological Surgery Practice of Long Island PLCCLake SuccessNew York11042-
Premier Cardiolog ConsultantsLake SuccessNew York11042-
Premier Cardiolog ConsultantsNew Hyde ParkNew York11042-
Premier Cardiology ConsultantsNew Hyde ParkNew York11042-
North Suffolk Neurology, PCPort Jefferson StationNew York11776-
Neurology Diagnostics Inc.DaytonOhio45459-

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