BHV3000 for Trigeminal Neuralgia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Trigeminal NeuralgiaRimegepant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From Baseline to End of Randomization Phase, up to 5 weeks.

From Baseline to End of Randomization Phase
Efficacy of BHV-3000 vs placebo for improving physical function in Trigeminal Neuralgia patients as measured by the Penn Facial Pain Scale-Revised
Week 5
Safety and tolerability (Incidence of treatment emergent adverse events) of BHV-3000 relative to placebo in patients with Trigeminal Neuralgia
Week 5
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.
Neuralgia
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.
Efficacy of BHV-3000 vs placebo on global functioning as measured by the Patient Global Impression of Change Scale.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

BHV3000
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: BHV3000 · Has Placebo Group · Phase 2

BHV3000
Drug
ActiveComparator Group · 1 Intervention: Rimegepant · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to end of randomization phase, up to 5 weeks.

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
46 Previous Clinical Trials
32,608 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person must have had symptoms of trigeminal neuralgia for at least 8 weeks before the randomization visit.
To exclude any other potential causes of the neuralgia, such as neurovascular compression, the patient underwent neuroimaging.
The study looked at people who had been diagnosed with trigeminal neuralgia, either typical or atypical.