Condition or disease | Intervention/treatment | Phase |
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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 : | December 15, 2021 |
Estimated Study Completion Date : | December 15, 2021 |
Arm | Intervention/treatment |
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Active Comparator: BHV3000 |
Drug: Rimegepant
BHV3000 (rimegepant) 75mg tablet
|
Placebo Comparator: Placebo |
Drug: Placebo
Placebo
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elyse Stock, MD | 203-404-0410 | clinicaltrials@biohavenpharma.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 | Recruiting |
New Orleans, Louisiana, United States, 70115 | |
Contact: Colleen Dionne 504-894-2864 colleen.dionne@ochsner.org | |
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 | |
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 |
Tracking Information | |||||
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First Submitted Date ICMJE | April 29, 2019 | ||||
First Posted Date ICMJE | May 8, 2019 | ||||
Last Update Posted Date | June 2, 2021 | ||||
Actual Study Start Date ICMJE | June 25, 2019 | ||||
Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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)
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Trial for Treatment Refractory Trigeminal Neuralgia | ||||
Official Title ICMJE | BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuraligia | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Trigeminal Neuralgia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 15, 2021 | ||||
Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03941834 | ||||
Other Study ID Numbers ICMJE | BHV3000-202 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Biohaven Pharmaceuticals, Inc. | ||||
Study Sponsor ICMJE | Biohaven Pharmaceuticals, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Biohaven Pharmaceuticals, Inc. | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |