| 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 : | December 15, 2021 |
| Estimated Study Completion Date : | December 15, 2021 |
| Arm | Intervention/treatment |
|---|---|
| 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 | |||||
|---|---|---|---|---|---|
| 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 |
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