## Protocol Section
### Identification Module
**NCT ID:** NCT06419582

**Brief Title:** BHV-7000 Acute Treatment of Bipolar Mania

**Official Title:** A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder

#### Organization Study ID Info
**ID:** BHV7000-204
#### Organization
**Class:** INDUSTRY
**Full Name:** Biohaven Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2025-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### 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

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.

### 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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 256

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BHV-7000

**Label:** BHV-7000

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BHV-7000

**Description:** BHV-7000 75 mg taken once daily for 21 days

**Name:** BHV-7000

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Matching placebo taken once daily for 21 days

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.

**Measure:** Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21

**Time Frame:** Baseline (day 1) to day 21

#### Secondary Outcomes

**Description:** This objective will be measured by the change in Clinical Global Impression of Severity (CGI-S) score from baseline (day 1) to day 21). The CGI-S is a global index of patient disease severity as rated by the clinician on a scale from 0 to 7, with 0 meaning not assessed and 7 reflecting the most severe patients.

**Measure:** Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score

**Time Frame:** Baseline (day 1) to day 21

**Description:** This objective will be measured by the change in YMRS total score from baseline (day 1) to day 7. The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60).

The higher the YMRS score, the more severe the subject's symptoms of mania.

**Measure:** Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7

**Time Frame:** Baseline (day 1) to day 7

**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:** Baseline (day 1) to day 21

**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:** Baseline (day 1) to day 21

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria:

1. Participant must be voluntarily hospitalized for a current manic episode.
2. Male and female participants 18 years to 75 years of age at the time of the screening visit.
3. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
4. Meets DSM-5 criteria for bipolar disorder type I, with or without mixed features, as confirmed by MINI interview with at least one well- defined prior mood episode (in addition to the current episode). The most recent prior manic episode must have occurred in the last 2 years.
5. Episode of mania must not exceed 12 weeks in duration.
6. Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications).

Key Exclusion Criteria:

1. Rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6 distinct mood episodes in a year. Consecutive mood episodes must be demarcated either by a partial or full remission of at least 2 months' duration or by a switch to an episode of opposite polarity. Each manic or mixed episode must have lasted at least 1 week, and each hypomanic episode must have lasted at least 4 days.
2. Participants with a confirmed lifetime history of schizophrenia, psychotic disorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic brain injury with clinically significant sequalae, seizure disorder, or other neurocognitive disorder. Previous diagnosis of psychotic spectrum disorders are allowable if the Investigator deems the diagnosis to be describing symptoms related to bipolar disorder.
3. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.

**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

#### Locations

**Location 1:**

**City:** Bentonville

**Contacts:**

***Contact 1:***

- **Email:** cpowell@pillarhc.com

- **Name:** Claudia Powell

- **Phone:** 479-367-2688

- **Role:** CONTACT

**Country:** United States

**Facility:** Pillar Clinical Research, LLC

**State:** Arkansas

**Status:** NOT_YET_RECRUITING

**Zip:** 72712

**Location 2:**

**City:** Little Rock

**Contacts:**

***Contact 1:***

- **Email:** apoole@ergclinical.com

- **Name:** Ashley Poole

- **Phone:** 501-221-8681

- **Role:** CONTACT

**Country:** United States

**Facility:** WIRG

**State:** Arkansas

**Status:** NOT_YET_RECRUITING

**Zip:** 72211

**Location 3:**

**City:** Rogers

**Contacts:**

***Contact 1:***

- **Email:** apoole@ergclinical.com

- **Name:** Ashley Poole

- **Phone:** 479-927-3000

- **Role:** CONTACT

**Country:** United States

**Facility:** WRN

**State:** Arkansas

**Status:** NOT_YET_RECRUITING

**Zip:** 72758

**Location 4:**

**City:** Anaheim

**Contacts:**

***Contact 1:***

- **Email:** dr.cho@arctrials.com

- **Name:** Austina Cho

- **Phone:** 714-999-8866

- **Role:** CONTACT

**Country:** United States

**Facility:** Advanced Research Center, Inc.

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 92805

**Location 5:**

**City:** Bellflower

**Contacts:**

***Contact 1:***

- **Email:** n.vera@cenexel.com

- **Name:** Nikita Vera

- **Phone:** 562-748-4999

- **Role:** CONTACT

**Country:** United States

**Facility:** CIT LA

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 90706

**Location 6:**

**City:** Culver City

**Contacts:**

***Contact 1:***

- **Email:** victoria.garin@prosciencerg.com

- **Name:** Victoria Garin

- **Phone:** 424-227-8127

- **Role:** CONTACT

**Country:** United States

**Facility:** ProScience Research Group

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 90230

**Location 7:**

**City:** Garden Grove

**Contacts:**

***Contact 1:***

- **Email:** a.lawlor@cenexel.com

- **Name:** Andrew Lawlor

- **Phone:** 714-799-7799

- **Role:** CONTACT

**Country:** United States

**Facility:** Cenexel CNS

**State:** California

**Status:** RECRUITING

**Zip:** 92845

**Location 8:**

**City:** Lemon Grove

**Contacts:**

***Contact 1:***

- **Email:** weisec@synergysandiego.com

- **Name:** Corey Weise

- **Phone:** 619-303-6130

- **Role:** CONTACT

**Country:** United States

**Facility:** Synergy San Diego

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 91945

**Location 9:**

**City:** Orange

**Contacts:**

***Contact 1:***

- **Email:** aparera@nrcresearch.com

- **Name:** Abigail Parera

- **Phone:** 714-289-1100

- **Role:** CONTACT

**Country:** United States

**Facility:** NRC Research Institute

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 92868

**Location 10:**

**City:** Riverside

**Contacts:**

***Contact 1:***

- **Email:** p.mansfield@cenexel.com

- **Name:** Paige Mansfield

- **Phone:** 951-300-4924

- **Role:** CONTACT

**Country:** United States

**Facility:** CIT IE

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 92506

**Location 11:**

**City:** Torrance

**Contacts:**

***Contact 1:***

- **Email:** D.Gainers@cenexel.com

- **Name:** Dakota Gainers

- **Phone:** 714-799-7799

- **Role:** CONTACT

**Country:** United States

**Facility:** Cenexel CNS

**State:** California

**Status:** NOT_YET_RECRUITING

**Zip:** 90504

**Location 12:**

**City:** Hollywood

**Contacts:**

***Contact 1:***

- **Email:** Jrichani@segaltrials.com

- **Name:** Jessmin Richani

- **Phone:** 954-375-7795

- **Role:** CONTACT

**Country:** United States

**Facility:** Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33021

**Location 13:**

**City:** Hollywood

**Contacts:**

***Contact 1:***

- **Email:** e.gomez@cenexel.com

- **Name:** Edwin Gomez

- **Phone:** 954-990-7649

- **Phone Ext:** 5303

- **Role:** CONTACT

**Country:** United States

**Facility:** Cenexel - RCA

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33024

**Location 14:**

**City:** Miami Lakes

**Contacts:**

***Contact 1:***

- **Email:** wmejia@floridiannsi.com

- **Name:** Wilmer Mejia

- **Phone:** 305-330-9977

- **Role:** CONTACT

**Country:** United States

**Facility:** Floridian Neuroscience Institute

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33016

**Location 15:**

**City:** Miami Lakes

**Contacts:**

***Contact 1:***

- **Email:** Gguzman@segaltrials.com

- **Name:** Genesis Guzman

- **Phone:** 786-570-1971

- **Role:** CONTACT

**Country:** United States

**Facility:** Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33016

**Location 16:**

**City:** Miami

**Contacts:**

***Contact 1:***

- **Email:** vsalinas@lccmedicalresearch.com

- **Name:** Vivian Salinas

- **Phone:** 305-400-0814

- **Role:** CONTACT

**Country:** United States

**Facility:** LCC Medical Research Inst

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33126

**Location 17:**

**City:** West Palm Beach

**Contacts:**

***Contact 1:***

- **Email:** jmahjabin@neuroscienceresearchinstitute.com

- **Name:** Jahan Mahjabin

- **Phone:** 561-578-8573

- **Role:** CONTACT

**Country:** United States

**Facility:** Neuroscience Research Institute

**State:** Florida

**Status:** NOT_YET_RECRUITING

**Zip:** 33407

**Location 18:**

**City:** Atlanta

**Contacts:**

***Contact 1:***

- **Email:** l.gibbs@cenexel.com

- **Name:** Leslie Gibbs

- **Phone:** 404-881-5800

- **Role:** CONTACT

**Country:** United States

**Facility:** Atlanta Center for Medical Research

**State:** Georgia

**Status:** NOT_YET_RECRUITING

**Zip:** 30331

**Location 19:**

**City:** Decatur

**Contacts:**

***Contact 1:***

- **Email:** K.Prowse@CenExel.com

- **Name:** Katherine Prowse

- **Phone:** 404-537-1281

- **Role:** CONTACT

**Country:** United States

**Facility:** CenExel iResearch, LLC

**State:** Georgia

**Status:** NOT_YET_RECRUITING

**Zip:** 30030

**Location 20:**

**City:** Savannah

**Contacts:**

***Contact 1:***

- **Email:** K.Prowse@CenExel.com

- **Name:** Katherine Prowse

- **Phone:** 912-744-0800

- **Role:** CONTACT

**Country:** United States

**Facility:** CenExel iResearch, LLC

**State:** Georgia

**Status:** NOT_YET_RECRUITING

**Zip:** 31405

**Location 21:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** sschneider@uptownresearch.com

- **Name:** Stephen Schneider

- **Phone:** 773-989-8313

- **Phone Ext:** 116

- **Role:** CONTACT

**Country:** United States

**Facility:** Uptown Research Institute

**State:** Illinois

**Status:** NOT_YET_RECRUITING

**Zip:** 60640

**Location 22:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** bcraig@pillarhc.com

- **Name:** Brian Craig

- **Phone:** 214-396-4844

- **Role:** CONTACT

**Country:** United States

**Facility:** Pillar Clinical Research

**State:** Illinois

**Status:** NOT_YET_RECRUITING

**Zip:** 60641

**Location 23:**

**City:** Gaithersburg

**Contacts:**

***Contact 1:***

- **Email:** e.covington@cenexel.com

- **Name:** Evan Covington

- **Phone:** 301-251-4702

- **Role:** CONTACT

**Country:** United States

**Facility:** CBH Health

**State:** Maryland

**Status:** NOT_YET_RECRUITING

**Zip:** 20877

**Location 24:**

**City:** Flowood

**Contacts:**

***Contact 1:***

- **Email:** shall@precise-research.com

- **Name:** Sara Hall

- **Phone:** 601-420-5812

- **Role:** CONTACT

**Country:** United States

**Facility:** Precise Clinical Research

**State:** Mississippi

**Status:** NOT_YET_RECRUITING

**Zip:** 39232

**Location 25:**

**City:** Saint Louis

**Contacts:**

***Contact 1:***

- **Email:** Idiab@archclinicaltrials.com

- **Name:** Israa Diab

- **Phone:** 314-266-1243

- **Role:** CONTACT

**Country:** United States

**Facility:** Arch Clinical Trials

**State:** Missouri

**Status:** NOT_YET_RECRUITING

**Zip:** 63141

**Location 26:**

**City:** Marlton

**Contacts:**

***Contact 1:***

- **Email:** l.white@cenexel.com

- **Name:** Lauren White

- **Phone:** 856-452-9901

- **Phone Ext:** 727

- **Role:** CONTACT

**Country:** United States

**Facility:** Hassman Research Institute

**State:** New Jersey

**Status:** RECRUITING

**Zip:** 08053

**Location 27:**

**City:** Staten Island

**Contacts:**

***Contact 1:***

- **Email:** dgruener@ergclinical.com

- **Name:** Daniel Gruener

- **Phone:** 718-317-5522

- **Role:** CONTACT

**Country:** United States

**Facility:** RBA

**State:** New York

**Status:** NOT_YET_RECRUITING

**Zip:** 10329

**Location 28:**

**City:** Dayton

**Contacts:**

***Contact 1:***

- **Email:** lwagner@ergclinical.com

- **Name:** Louis Wagner

- **Phone:** 937-424-1050

- **Role:** CONTACT

**Country:** United States

**Facility:** Midwest Clinical Research Center

**State:** Ohio

**Status:** NOT_YET_RECRUITING

**Zip:** 45417

**Location 29:**

**City:** North Canton

**Contacts:**

***Contact 1:***

- **Email:** apabbisetty@nb-cr.com

- **Name:** Aparna Pabbisetty

- **Phone:** 330-493-1118

- **Role:** CONTACT

**Country:** United States

**Facility:** NBCR

**State:** Ohio

**Status:** NOT_YET_RECRUITING

**Zip:** 44720

**Location 30:**

**City:** Austin

**Contacts:**

***Contact 1:***

- **Email:** missy.ward@communityclinical.com

- **Name:** Missy Ward

- **Phone:** 512-597-6704

- **Role:** CONTACT

**Country:** United States

**Facility:** Community Clinical Research, Inc.

**State:** Texas

**Status:** NOT_YET_RECRUITING

**Zip:** 78754

**Location 31:**

**City:** DeSoto

**Contacts:**

***Contact 1:***

- **Email:** BGreenHR@outlook.com

- **Name:** Brian Green

- **Phone:** 972-283-6286

- **Role:** CONTACT

**Country:** United States

**Facility:** InSite Clinical Research, LLC

**State:** Texas

**Status:** RECRUITING

**Zip:** 75115

**Location 32:**

**City:** Richardson

**Contacts:**

***Contact 1:***

- **Email:** bcraig@pillarhc.com

- **Name:** Brian Craig

- **Phone:** 214-396-4844

- **Role:** CONTACT

**Country:** United States

**Facility:** Pillar Clinical Research, LLC

**State:** Texas

**Status:** NOT_YET_RECRUITING

**Zip:** 75080

## 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

- Abbrev: Rare

- Name: Rare Diseases

### 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

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001714

- Term: Bipolar Disorder

### Misc Info Module

- Version Holder: 2024-05-31
