BHV-7000 for Bipolar Disorder

No longer recruiting at 32 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biohaven Therapeutics Ltd.

Disqualifiers: Medical condition, Adherence issues, Risk to self/others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BHV-7000 for individuals with bipolar I disorder. The goal is to determine if the treatment is safe and tolerable over an extended period. Those who completed an earlier related study and are not pregnant or breastfeeding might be suitable candidates for this trial. The researchers aim to ensure the treatment's safety and effectiveness for everyday use in managing bipolar I disorder. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in bipolar I disorder treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that BHV-7000 is likely to be safe for humans?

Research has shown that BHV-7000 is generally safe for people. In previous studies, participants tolerated doses up to 120 mg daily for 15 days well, which exceeds the doses tested in some current studies. Importantly, no serious adverse reactions were reported. Additionally, BHV-7000 did not cause the common side effects associated with similar medications. This makes it a promising option for those considering participation in a clinical trial for bipolar disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BHV-7000 is unique because it targets bipolar disorder in a novel way. While most treatments for bipolar disorder, like mood stabilizers and antipsychotics, often focus on balancing neurotransmitters like serotonin and dopamine, BHV-7000 works differently. It targets a specific ion channel in the brain, which could lead to more precise regulation of brain activity. Researchers are excited about this approach because it has the potential to reduce side effects and improve effectiveness compared to current treatments. This could be a game-changer for individuals who haven't found relief with existing options.

What evidence suggests that BHV-7000 might be an effective treatment for bipolar disorder?

Research has shown that BHV-7000 has been safe and effective in some early studies, particularly for seizure-related conditions. However, a recent study on bipolar disorder did not demonstrate a clear benefit in reducing symptoms compared to a placebo. Despite this, the medication was safe and well-tolerated, with no serious side effects. This suggests that while BHV-7000 might not yet be proven effective for bipolar disorder, it remains safe for further research. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have bipolar I disorder and have completed the parent study BHV7000-204. Women of childbearing potential (WOCBP) must not be pregnant, breastfeeding, or lactating to participate.

Inclusion Criteria

I am not breastfeeding or planning to during the study.

I am a woman of childbearing potential and my pregnancy test before starting the trial was negative.

I completed the BHV7000-204 study successfully.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-7000 to assess long-term safety and tolerability

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BHV-7000

Trial Overview The focus of this study is on assessing the long-term safety and tolerability of a medication called BHV-7000 in people with bipolar I disorder.

How Is the Trial Designed?

Group I: BHV-7000 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+

Citations

1. ir.biohaven.com ir.biohaven.com/news-releases/news-release-details/biohaven-presents-new-data-bhv-7000-once-daily-extended-release

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 being evaluated ...

2. psychiatrictimes.com psychiatrictimes.com/view/bhv-7000-for-bipolar-disorder-fails-in-phase-2-3-trial

BHV-7000 for Bipolar Disorder Fails in Phase 2/3 Trial BHV-7000 failed to achieve statistical significance in a bipolar trial but was safe and well-tolerated, with no serious adverse events.

3. neurologylive.com neurologylive.com/view/antiseizure-agent-bhv-7000-demonstrates-positive-safety-efficacy-results-phase-1-study

Antiseizure Agent BHV-7000 Demonstrates Positive Safety, ... Antiseizure Agent BHV-7000 Demonstrates Positive Safety, Efficacy Results in Phase 1 Study. Findings from the study further confirmed target ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06419582?cond=%22Mania%22&viewType=Table&rank=2

NCT06419582 | BHV-7000 Acute Treatment of Bipolar Mania The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000206409

Phase 1 Study Evaluating the Safety and Tolerability of ... BHV-7000 was safe and well tolerated, without the typical AEs associated with other anti-seizure medications. These findings support the ...

6. ctv.veeva.com ctv.veeva.com/study/bhv-7000-open-label-extension-bipolar-mania-study

BHV-7000 Open-Label Extension Bipolar Mania Study The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.

7. prnewswire.com prnewswire.com/news-releases/biohaven-presents-new-data-with-bhv-7000-once-daily-extended-release-formulation-demonstrating-excellent-safety-profile-and-nonclinical-data-updates-at-american-epilepsy-society-2024-annual-meeting-302324613.html

Biohaven 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 ...