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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

BHV3000 for Trigeminal Neuralgia

Phase 2
Waitlist Available
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to end of randomization phase, up to 5 weeks.
Awards & highlights

Study Summary

This trial will compare the effectiveness of BHV3000 to a placebo for subjects with Trigeminal Neuralgia that haven't responded to other treatments. The pain scale will be used to measure the difference between the two-week treatment phases.

Eligible Conditions
  • Trigeminal Neuralgia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to end of randomization phase up to 5 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to end of randomization phase up to 5 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Neuralgia
Efficacy of BHV-3000 vs placebo for improving physical function in Trigeminal Neuralgia patients as measured by the Penn Facial Pain Scale-Revised
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.
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BHV3000Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
37,105 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,843 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,011 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an innovative clinical trial?

"Since 2019, BHV3000 has been under scrutiny by Biohaven Pharmaceuticals, Inc. in order to gain drug approval after their Phase 1 trial which involved 60 patients. Nowadays there are 6 active trials occurring across 251 cities and 9 nations."

Answered by AI

Are there vacancies for participants in this clinical investigation?

"Affirmative. The information available on clinicaltrials.gov suggests that this medical trial is actively seeking participants, with the initial post date being June 25th 2019 and last update occurring October 4th 2022. Sixty patients will be recruited from 10 locations for this study."

Answered by AI

Could you provide an estimate of the number of individuals partaking in this clinical research?

"Affirmative. Data hosted on clinicaltrials.gov indicates that the trial, which commenced recruitment on June 25th 2019, is still in progress and looking for 60 participants to join from 10 different locations."

Answered by AI

How widely distributed is the clinical trial in this urban area?

"SouthCoast Research Center in Miami, Center for Neurohealth: Kaizen Brain Center in La Jolla, and Gilbert Neurology Partners/CCT Research in Gilbert are just three of the 10 available locations."

Answered by AI

What risk factors accompany the application of BHV3000?

"The safety of BHV3000 is estimated to be a 2 as it has only been tested in Phase 2 trials, and thus there is some evidence for its security but no confirmation of its efficacy."

Answered by AI

Are there any antecedent experiments involving BHV3000?

"BHV3000 was initially examined in 2019 at Neurology Diagnostics Inc., and since then there has been an accumulation of 18329 completed studies. At the present, 6 clinical trials are still active; a substantial number of these investigations have taken place out of Miami, Florida."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Arizona
Maryland
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Stanford University
Gilbert Neurology Partners/CCT Research
Neurological Surgery, PC
Other

Why did patients apply to this trial?

I've had tn on the left side of my face for 8 years. Now, it is also on the right side. I have tried various meds, nerve blocks, burning of nerve, etc...will little relief.
PatientReceived 2+ prior treatments
I've tried 8 drugs, dietary changes, and had radiosurgery for Trigeminal Neuralgia, but none have helped. I have Atypical TN (both constant burning pain and intermittent, intense electric-shock pain), related to Multiple Sclerosis.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Trial for Treatment Refractory Trigeminal Neuralgia
2019. "Trial for Treatment Refractory Trigeminal Neuralgia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03941834.
~5 spots leftby Apr 2025
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