Trial for Treatment Refractory Trigeminal Neuralgia

• Sponsor: Biohaven Pharmaceuticals, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03941834
• Collaborator: (none)
• Enrollment: 60
• Locations: 11
• Arms: 2
• Anticipated Duration (Months): 46.3
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia	Drug: Rimegepant; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 25, 2019
• Anticipated Primary Completion Date: Feb 9, 2023
• Anticipated Study Completion Date: May 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BHV3000	Drug: Rimegepant; BHV3000 (rimegepant) 75mg tablet
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. 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. [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)

Secondary Outcome Measures

1. Safety and tolerability (Incidence of treatment emergent adverse events) of BHV-3000 relative to placebo in patients with Trigeminal Neuralgia [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.

2. Efficacy of BHV-3000 vs placebo for improving physical function in Trigeminal Neuralgia patients as measured by the Penn Facial Pain Scale-Revised [From Baseline to End of Randomization Phase]

   12 questions in which the higher the score the more pain and disability

3. Efficacy of BHV-3000 vs placebo for improving functional disability in Trigeminal Neuralgia patients as measured by the Pain Disability Index [From Baseline to End of Randomization Phase, up to 5 weeks.]

   7 question's that are Scored 0-10, ten being more disabled.

4. Efficacy of BHV-3000 vs placebo on global functioning as measured by the Patient Global Impression of Change Scale. [From Baseline to End of Randomization Phase, up to 5 weeks.]

   Measured by a likert scale from No change to a great deal better.

5. 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. [From Baseline to End of Randomization Phase, up to 5 weeks.]

   11 point numeric rating scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects with a clinical diagnosis of typical or atypical classical trigeminal neuralgia based on the International Classification of Headache Disorders, 3rd edition, beta version.

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:

1. Subject has a structural lesion on neuroimaging, other than vascular compression of the trigeminal nerve or nerve root that would explain the neuralgia

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gilbert Neurology Partners/CCT Research	Gilbert	Arizona	United States	85297
2	Center for Neurohealth: Kaizen Brain Center	La Jolla	California	United States	92037
3	Stanford University	Stanford	California	United States	94305
4	SouthCoast Research Center	Miami	Florida	United States	33136
5	Ochsner Baptist Medical Center	New Orleans	Louisiana	United States	70115
6	Johns Hopkins University	Baltimore	Maryland	United States	21287
7	Clinical Research Professionals	Chesterfield	Missouri	United States	63005
8	Dent Neurological Institute	Amherst	New York	United States	14226
9	Neurological Surgery, PC	Lake Success	New York	United States	11042
10	North Suffolk Neurology	Port Jefferson Station	New York	United States	11776
11	Neurology Diagnostics Inc.	Dayton	Ohio	United States	45459

Sponsors and Collaborators

• Biohaven Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biohaven Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03941834
• Other Study ID Numbers: BHV3000-202
• First Posted: May 8, 2019
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Biohaven Pharmaceuticals, Inc.: Trigeminal Neuralgia, Pain
• Additional relevant MeSH terms: Trigeminal Neuralgia; Neuralgia

Study Results

No Results Posted as of Aug 1, 2022