Trial for Treatment Refractory Trigeminal Neuralgia
Primary Purpose
Trigeminal Neuralgia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rimegepant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Trigeminal Neuralgia, Pain
Eligibility Criteria
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
- 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
Sites / Locations
- Gilbert Neurology Partners, PLLC/CCT Research
- Center for Neurohealth DBA Kaizen Brain Center
- Imaging Clinic at Stanford Neuroscience Health Center
- Stanford Hoover Pavilion
- Stanford Neuroscience Health Center- SNHC Pharmacy
- Stanford Neuroscience Health Center
- Stanford University- CAM Building
- SouthCoast Research Center
- Ochsner Baptist Medical Center
- Johns Hopkins Clinical Outpatient Center
- Johns Hopkins ICTR Clinical Research Unit (CRU)
- Clinical Research Professionals
- Dent Neurosciences Research Center
- Neurological Surgery Practice of Long Island PLCC
- Neurological Surgery
- Premier Cardiolog Consultants
- Premier Cardiology Consultants
- North Suffolk Neurology, PC
- Neurology Diagnostics Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
BHV3000
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Efficacy of BHV-3000 compared to placebo in providing symptomatic pain relief in patients with refractory Trigeminal Neuralgia, as measured by a 2-point or greater reduction in the average Numeric Pain Rating Scale.
Change in mean NPRS between the treatment phase. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Secondary Outcome Measures
Safety and tolerability (Incidence of treatment emergent adverse events) of BHV-3000 relative to placebo in patients with Trigeminal Neuralgia
Safety and tolerability will be measured by the frequency and severity of adverse events and discontinuations due to adverse events.
Efficacy of BHV-3000 vs placebo for improving physical function in Trigeminal Neuralgia patients as measured by the Penn Facial Pain Scale-Revised
12 questions in which the higher the score the more pain and disability
Efficacy of BHV-3000 vs placebo for improving functional disability in Trigeminal Neuralgia patients as measured by the Pain Disability Index
7 question's that are Scored 0-10, ten being more disabled.
Efficacy of BHV-3000 vs placebo on global functioning as measured by the Patient Global Impression of Change Scale.
Measured by a likert scale from No change to a great deal better.
Efficacy of BHV-3000 vs placebo in providing symptomic pain relief as captured by daily rating of worst pain episode as measured by the 11 point numeric rating scale.
11 point numeric rating scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03941834
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
May 11, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
Trigeminal Neuralgia, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BHV3000
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Intervention Description
BHV3000 (rimegepant) 75mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Efficacy of BHV-3000 compared to placebo in providing symptomatic pain relief in patients with refractory Trigeminal Neuralgia, as measured by a 2-point or greater reduction in the average Numeric Pain Rating Scale.
Description
Change in mean NPRS between the treatment phase. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)
Time Frame
From Baseline to End of Randomization Phase, up to 5 weeks.
Secondary Outcome Measure Information:
Title
Safety and tolerability (Incidence of treatment emergent adverse events) of BHV-3000 relative to placebo in patients with Trigeminal Neuralgia
Description
Safety and tolerability will be measured by the frequency and severity of adverse events and discontinuations due to adverse events.
Time Frame
From Baseline to End of Randomization Phase up to 5 weeks.
Title
Efficacy of BHV-3000 vs placebo for improving physical function in Trigeminal Neuralgia patients as measured by the Penn Facial Pain Scale-Revised
Description
12 questions in which the higher the score the more pain and disability
Time Frame
From Baseline to End of Randomization Phase
Title
Efficacy of BHV-3000 vs placebo for improving functional disability in Trigeminal Neuralgia patients as measured by the Pain Disability Index
Description
7 question's that are Scored 0-10, ten being more disabled.
Time Frame
From Baseline to End of Randomization Phase, up to 5 weeks.
Title
Efficacy of BHV-3000 vs placebo on global functioning as measured by the Patient Global Impression of Change Scale.
Description
Measured by a likert scale from No change to a great deal better.
Time Frame
From Baseline to End of Randomization Phase, up to 5 weeks.
Title
Efficacy of BHV-3000 vs placebo in providing symptomic pain relief as captured by daily rating of worst pain episode as measured by the 11 point numeric rating scale.
Description
11 point numeric rating scale.
Time Frame
From Baseline to End of Randomization Phase, up to 5 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Gilbert Neurology Partners, PLLC/CCT Research
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Center for Neurohealth DBA Kaizen Brain Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Imaging Clinic at Stanford Neuroscience Health Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford Hoover Pavilion
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford Neuroscience Health Center- SNHC Pharmacy
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford Neuroscience Health Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University- CAM Building
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
SouthCoast Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Ochsner Baptist Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Johns Hopkins Clinical Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Johns Hopkins ICTR Clinical Research Unit (CRU)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Neurological Surgery Practice of Long Island PLCC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Neurological Surgery
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Premier Cardiolog Consultants
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Premier Cardiology Consultants
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
North Suffolk Neurology, PC
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Neurology Diagnostics Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-202
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Trial for Treatment Refractory Trigeminal Neuralgia
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