Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
65 participants
INTERVENTIONAL
2019-06-25
2023-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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BHV3000
Rimegepant
BHV3000 (rimegepant) 75mg tablet
Placebo
Placebo
Placebo
Interventions
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Rimegepant
BHV3000 (rimegepant) 75mg tablet
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4951014
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3000-202
Identifier Type: -
Identifier Source: org_study_id
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