## Protocol Section
### Identification Module
**NCT ID:** NCT06423781

**Brief Title:** Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)

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

#### Organization Study ID Info
**ID:** BHV7000-203
#### Organization
**Class:** INDUSTRY
**Full Name:** Biohaven Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2027-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**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 participants with Major Depressive Disorder (MDD).

### Conditions Module

**Conditions:**

- Major Depressive Disorder

**Keywords:**

- depression

- major depression

- antidepressant

- major depressive disorder

- MDD

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 480

**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:** Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication

**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

**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

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria:

1. Eligible participants must have successfully completed the Treatment/Randomization Phase of parent studies.
2. WOCBP must have a negative urine pregnancy test at Baseline Visit.
3. WOCBP must not be breastfeeding or lactating at Baseline Visit or at any point during 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. Participant non-compliance with study procedures, study drug or visit attendance in the parent study that the Investigator deems as clinically significant or unacceptable risk potential for this study.
3. Investigator deems participant at imminent risk of danger to others.

**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: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7060

- Name: Depressive Disorder, Major

- Relevance: HIGH

- As Found: Major Depressive Disorder

- 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

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

- ID: D000003863

- Term: Depression

- ID: D000003865

- Term: Depressive Disorder, Major

### Intervention Browse Module - Browse Branches

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
