BHV-7000 for Erythromelalgia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BHV-7000, a potential drug, to determine if it can reduce chronic pain in people with erythromelalgia, a condition causing episodes of burning pain, usually in the feet and hands. The trial targets individuals with this condition due to a specific gene mutation known as NaV1.7, which affects pain signal transmission in the body. Participants will receive either the new treatment or a placebo (a substance with no active medicine) to compare effects. This trial may suit adults diagnosed with inherited erythromelalgia who manage their pain with a stable medication routine. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that BHV-7000 is likely to be safe for humans?
Research has shown that BHV-7000 appears safe and easy to tolerate. In recent studies, participants taking up to 120 mg of BHV-7000 daily for 15 days did not experience severe side effects requiring dose reduction. Importantly, there were no negative effects on the brain or nervous system, common concerns with similar treatments. Overall, the evidence suggests that BHV-7000 has been well-tolerated in humans so far.12345
Why do researchers think this study treatment might be promising for erythromelalgia?
Most treatments for erythromelalgia, such as gabapentin and lidocaine, focus on managing symptoms by reducing nerve pain or improving blood flow. But BHV-7000 is unique because it works differently, targeting specific ion channels in nerve cells to address the underlying cause of the pain. Researchers are excited about BHV-7000 because its novel approach could provide more effective and longer-lasting relief compared to existing therapies, potentially improving the quality of life for patients with this challenging condition.
What evidence suggests that BHV-7000 might be an effective treatment for erythromelalgia?
Research has shown that BHV-7000, which participants in this trial may receive, may help reduce chronic pain in people with inherited erythromelalgia (IEM), a condition caused by a change in the SCN9A gene. This change leads to overly active nerve pain signals. Studies indicate that BHV-7000 can decrease these pain signals in nerve cells from IEM patients. In lab tests, BHV-7000 also adjusts the electrical charge across nerve cell membranes, helping to stabilize them and potentially reduce pain. These findings suggest that BHV-7000 could help manage pain in those with IEM by calming overactive nerve signals.15678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with inherited erythromelalgia (IEM) due to a specific NaV1.7 gene mutation causing chronic pain. Participants must not have other mutations affecting Kv7.2/7.3 function, should be able to follow study procedures and keep accurate pain diaries, and maintain their current pain medication regimen.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BHV-7000 or placebo in a 4-week crossover treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BHV-7000
Trial Overview
The trial is testing BHV-7000's effectiveness in reducing chronic pain against a placebo in participants with IEM linked to the SCN9A gene mutation. It's an early-phase study where some people will receive the actual drug while others will get a placebo for comparison.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biohaven Therapeutics Ltd.
Lead Sponsor
Citations
NCT07262268 | A Phase 1b Study of BHV-7000 in ...
The purpose of this study is to test the potential benefits of BHV-7000 in reducing chronic pain in participants with IEM with a previously ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/5bf33d5593288cfd/nct07262268-bhv-7000-inherited-erythromelalgia-nav1-7-mutationsA Phase 1b Study of BHV-7000 in Participants With Inherited ...
The purpose of this study is to test the potential benefits of BHV-7000 in reducing chronic pain in participants with IEM with a previously ...
Effects of BHV-7000 on Human iPSC-Derived Sensory ...
This cell showed a stable RMP of -67 mV during the baseline period and a clear shift of RMP to -72 mV in response to BHV-7000.
4.
ir.biohaven.com
ir.biohaven.com/news-releases/news-release-details/biohaven-showcases-broad-innovative-portfolio-and-pipelinePress Release Details
Presented new data showing BHV-7000 attenuates action potential firing in inherited erythromelalgia (IEM) patient-derived sensory neuron ...
Biohaven Presents New Data with BHV-7000 Once-Daily ...
Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation ...
6.
ir.biohaven.com
ir.biohaven.com/news-releases/news-release-details/biohaven-presents-new-data-bhv-7000-once-daily-extended-releaseBiohaven Presents New Data with BHV-7000 Once-Daily ...
We are encouraged to see BHV-7000 continue to demonstrate favorable safety and tolerability without dose-limiting toxicities or CNS adverse ...
bhvn-20241231
In December 2024, t the American Epilepsy Society meeting, we presented additional safety data with the BHV-7000 once-daily extended-release formulation, which ...
8.
ir.biohaven.com
ir.biohaven.com/news-releases/news-release-details/biohaven-presents-expanded-eeg-and-safety-data-bhv-7000-americanPress Release Details
We are pleased to see favorable safety and tolerability with BHV-7000 dosed up to 120 mg daily for 15 days, without the CNS adverse effects ...
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