Trial for Treatment Refractory Trigeminal Neuralgia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03941834 |
Recruitment Status :
Recruiting
First Posted : May 8, 2019
Last Update Posted : May 20, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Trigeminal Neuralgia | Drug: Rimegepant Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuraligia |
Actual Study Start Date : | June 25, 2019 |
Estimated Primary Completion Date : | February 9, 2023 |
Estimated Study Completion Date : | May 4, 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: BHV3000 |
Drug: Rimegepant
BHV3000 (rimegepant) 75mg tablet |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo |
- 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. [ Time Frame: From Baseline to End of Randomization Phase, up to 5 weeks. ]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)
- Safety and tolerability (Incidence of treatment emergent adverse events) of BHV-3000 relative to placebo in patients with Trigeminal Neuralgia [ Time Frame: From Baseline to End of Randomization Phase up to 5 weeks. ]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 [ Time Frame: From Baseline to End of Randomization Phase ]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 [ Time Frame: From Baseline to End of Randomization Phase, up to 5 weeks. ]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. [ Time Frame: From Baseline to End of Randomization Phase, up to 5 weeks. ]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. [ Time Frame: From Baseline to End of Randomization Phase, up to 5 weeks. ]11 point numeric rating scale.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941834
Contact: Elyse Stock, MD | 203-404-0410 | clinicaltrials@biohavenpharma.com |
United States, Arizona | |
Gilbert Neurology Partners/CCT Research | Recruiting |
Gilbert, Arizona, United States, 85297 | |
Contact: Jessica Padilla 602-761-9631 jessicapadilla@cctresearch.com | |
United States, California | |
Center for Neurohealth: Kaizen Brain Center | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Nancy Tomka 858-294-0161 research@kaizenbraincenter.com | |
Stanford University | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Anthony Bet 650-683-5823 abet0915@stanford.edu | |
United States, Florida | |
SouthCoast Research Center | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Lourdes Martinez 786-343-6937 sc2@southresearch.org | |
United States, Louisiana | |
Ochsner Baptist Medical Center | Withdrawn |
New Orleans, Louisiana, United States, 70115 | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Whitney Isennock 410-955-7008 wwebb10@jhmi.edu | |
United States, Missouri | |
Clinical Research Professionals | Recruiting |
Chesterfield, Missouri, United States, 63005 | |
Contact: Malana Kanallakan 636-220-1200 recruitment@clinicalresearchprofessionals.net | |
United States, New York | |
Dent Neurological Institute | Recruiting |
Amherst, New York, United States, 14226 | |
Contact: Rebecca Hogan 716-558-5670 rhogan@dentinstitute.com | |
Neurological Surgery, PC | Recruiting |
Lake Success, New York, United States, 11042 | |
Contact: Stephanie Ramjattan 516-478-0008 sramjattan@nspc.com | |
North Suffolk Neurology | Recruiting |
Port Jefferson Station, New York, United States, 11776 | |
Contact: Matthew Kluko 631-629-8810 mkluko@nsneuro.net | |
United States, Ohio | |
Neurology Diagnostics Inc. | Recruiting |
Dayton, Ohio, United States, 45459 | |
Contact: Taylor Rhodes 937-224-8200 taylor.rhodes@neurologydiagnostics.com |
Responsible Party: | Biohaven Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03941834 |
Other Study ID Numbers: |
BHV3000-202 |
First Posted: | May 8, 2019 Key Record Dates |
Last Update Posted: | May 20, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Trigeminal Neuralgia, Pain |
Trigeminal Neuralgia Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations |
Trigeminal Nerve Diseases Facial Neuralgia Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases |