## Protocol Section
### Identification Module
**NCT ID:** NCT06423794

**Brief Title:** BHV-7000 Open-Label Extension Bipolar Mania Study

**Official Title:** A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Bipolar I Disorder

#### Organization Study ID Info
**ID:** BHV7000-202
#### Organization
**Class:** INDUSTRY
**Full Name:** Biohaven Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Biohaven Therapeutics Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

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

### Conditions Module

**Conditions:**

- Bipolar Disorder

**Keywords:**

- bipolar

- mania

- manic episode

- manic state

- bipolar disorder type 1

- manic depressive

- manic bipolar

- mixed features

- mixed episode

- mixed mania

- bipolar episode

- bipolar disorder

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BHV-7000

**Label:** BHV-7000

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BHV-7000

**Description:** BHV-7000 75 mg taken once daily

**Name:** BHV-7000

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities.

**Measure:** Number of Participants With Clinically Significant Laboratory Abnormalities

**Time Frame:** Up to 52 weeks

**Description:** To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days).

**Measure:** Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication

**Time Frame:** Up to 52 weeks

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria:

1. Subjects must have successfully completed the parent study, BHV7000-204.
2. WOCBP must have a negative urine pregnancy test at Baseline visit.
3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.

Key Exclusion Criteria:

1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.
3. Investigator deems subject at imminent risk of danger to others or themself.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrials@biohavenpharma.com

**Name:** Chief Medical Officer

**Phone:** 203-404-0410

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068105

- Term: Bipolar and Related Disorders

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4996

- Name: Bipolar Disorder

- Relevance: HIGH

- As Found: Bipolar Disorder

- ID: M2598

- Name: Mania

- Relevance: LOW

- As Found: Unknown

- ID: M226

- Name: Bipolar and Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001714

- Term: Bipolar Disorder

### Misc Info Module

- Version Holder: 2024-05-31
