BHV-7000 for Bipolar Disorder

No longer recruiting at 33 trial locations

Overseen By Louis Wagner

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Biohaven Therapeutics Ltd.

Must not be taking: Antidepressants, Antimanics, Antipsychotics

Disqualifiers: Rapid cycling, Schizophrenia, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 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 disorder I who are experiencing a manic episode. Researchers aim to determine if BHV-7000 is safe and effective for treating these episodes. Participants will receive either BHV-7000 or a placebo (a substance with no active drug) to compare results. This trial may suit those currently hospitalized for mania and who have experienced a manic episode within the last two years. As a Phase 2, Phase 3 trial, the study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

Yes, you will need to stop taking all other psychotropic medications (like antidepressants, antimanic, and antipsychotic medications) during the screening phase of the trial.

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

Research has shown that BHV-7000 is generally safe and well-tolerated. In one study, participants took up to 120 mg daily for 15 days without experiencing serious side effects or issues that would prevent higher doses. Another study found that BHV-7000 did not cause the common side effects often seen with other anti-seizure medications. Additionally, a trial focused on bipolar disorder reported no severe health issues with BHV-7000. Overall, these findings suggest that BHV-7000 has a good safety record, making it a potential option for those interested in joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bipolar disorder?

BHV-7000 is unique because it offers a new approach to treating bipolar disorder by targeting a different mechanism in the brain. Most treatments for bipolar disorder, such as mood stabilizers and antipsychotics, work by balancing neurotransmitters like dopamine and serotonin. In contrast, BHV-7000 is believed to modulate other pathways linked to mood regulation, which could potentially provide relief for patients who don't respond well to existing medications. Researchers are excited about BHV-7000 because it might offer fewer side effects and quicker stabilization of mood swings, making it a promising option for those with bipolar disorder.

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

Research has shown that BHV-7000 is safe, with no serious side effects reported in earlier studies. However, in this trial, participants receiving BHV-7000 for bipolar disorder may not experience significant improvement in manic episodes compared to those receiving a placebo. Although safe, it did not outperform a placebo in reducing symptoms. BHV-7000 is also under study for its potential to treat seizures, where earlier trials showed promising results. Overall, while BHV-7000 is safe, its effectiveness for treating bipolar mania remains uncertain based on current research. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with a BMI of ≥18 and ≤35, diagnosed with bipolar disorder type I. They must have had at least one previous manic episode in the last two years and be hospitalized voluntarily for a current manic episode. Participants need to stop other psychotropic meds during screening.

Inclusion Criteria

My manic episodes last no longer than 12 weeks.

My BMI is between 18 and 35.

I am voluntarily in the hospital for a current manic episode.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-7000 or placebo for the acute treatment of manic episodes in bipolar disorder I

3 weeks

Inpatient visits

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 study tests if BHV-7000 is safe and effective for treating acute mania in bipolar disorder I patients compared to a placebo. It's designed to see how well it works when participants are experiencing an active manic episode.

How Is the Trial Designed?

Group I: BHV-7000 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 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 ...