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Trial for Treatment Refractory Trigeminal Neuralgia

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ClinicalTrials.gov Identifier: NCT03941834
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to evaluate the efficacy of BHV3000 compared to placebo for subjects with Trigeminal Neuralgia as measured by a 2-point or greater reduction in the Numeric Pain Rating Scale at the end of each two-week treatment phase for each sequence.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Drug: Rimegepant Drug: Placebo Phase 2

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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 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BHV3000 Drug: Rimegepant
BHV3000 (rimegepant) 75mg tablet

Placebo Comparator: Placebo Drug: Placebo
Placebo




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. [ 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. Efficacy of BHV-3000 vs placebo in improving emotional functioning as measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: From Randomization to end of treatment period, up to 5 weeks. ]
    The higher the HADS score the more anxious and/or depressed

  6. Efficacy of BHV-3000 vs placebo in providing 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
Criteria

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 three months prior to screening 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 neurologic deficit on neurologic exam
  3. Subjects 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), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
  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 >30kg/m²

Information from the National Library of Medicine

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


Contacts
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Contact: Elyse Stock, MD 203-404-0410 clinicaltrials@biohavenpharma.com

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Whitney Isennock    410-955-7008    wwebb10@jhmi.edu   
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03941834     History of Changes
Other Study ID Numbers: BHV3000-202
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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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:
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Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases