BHV-7000 for Bipolar Disorder

Recruiting at 31 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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: BHV-7000 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+