## Protocol Section
### Identification Module
**NCT ID:** NCT06413433

**Acronym:** ENGAGE

**Brief Title:** Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

**Official Title:** A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

#### Organization Study ID Info
**ID:** SOL-BED-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Axsome Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-26

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Axsome Therapeutics, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.

**Detailed Description:** Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks.

### Conditions Module

**Conditions:**

- Binge-Eating Disorder

**Keywords:**

- Binge eating disorder

- BED

- Solriamfetol

- Sunosi

- Axsome

- Non-stimulant therapy

- Dopamine norepinephrine reuptake inhibitor

- Trace amine-associated receptor 1 (TAAR1) agonist

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 450

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Up to 12 weeks

**Intervention Names:**

- Drug: Solriamfetol 150 mg

**Label:** Solriamfetol 150 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Up to 12 weeks

**Intervention Names:**

- Drug: Solriamfetol 300 mg

**Label:** Solriamfetol 300 mg

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Up to 12 weeks

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Solriamfetol 150 mg

**Description:** Solriamfetol tablets, taken once daily

**Name:** Solriamfetol 150 mg

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Solriamfetol 300 mg

**Description:** Solriamfetol tablets, taken once daily

**Name:** Solriamfetol 300 mg

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo

**Description:** Placebo tablets, taken once daily

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change from Baseline to Week 12 in number of binge eating episodes

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Primary diagnosis of BED according to DSM-5 criteria.
* Provides written informed consent to participate in the study before the conduct of any study procedures.
* Male or female, aged 18 to 55 inclusive.

Exclusion Criteria:

* Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sol-bed-301@axsome.com

**Name:** Study Director

**Phone:** 212-332-5061

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Encino

**Country:** United States

**Facility:** Clinical Research Site

**State:** California

**Status:** RECRUITING

**Zip:** 91316

**Location 2:**

**City:** Newport Beach

**Country:** United States

**Facility:** Clinical Research Site

**State:** California

**Status:** RECRUITING

**Zip:** 92660

**Location 3:**

**City:** San Diego

**Country:** United States

**Facility:** Clinical Research Site

**State:** California

**Status:** RECRUITING

**Zip:** 92103

**Location 4:**

**City:** Clermont

**Country:** United States

**Facility:** Clinical Research Site

**State:** Florida

**Status:** RECRUITING

**Zip:** 34711

**Location 5:**

**City:** Jacksonville

**Country:** United States

**Facility:** Clinical Research Site

**State:** Florida

**Status:** RECRUITING

**Zip:** 32256

**Location 6:**

**City:** Orlando

**Country:** United States

**Facility:** Clinical Research Site

**State:** Florida

**Status:** RECRUITING

**Zip:** 32801

**Location 7:**

**City:** Orlando

**Country:** United States

**Facility:** Clinical Research Site

**State:** Florida

**Status:** RECRUITING

**Zip:** 32806

**Location 8:**

**City:** Marietta

**Country:** United States

**Facility:** Clinical Research Site

**State:** Georgia

**Status:** RECRUITING

**Zip:** 30060

**Location 9:**

**City:** Overland Park

**Country:** United States

**Facility:** Clinical Research Site

**State:** Kansas

**Status:** RECRUITING

**Zip:** 66210

**Location 10:**

**City:** Methuen

**Country:** United States

**Facility:** Clinical Research Site

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 01844

**Location 11:**

**City:** Saint Charles

**Country:** United States

**Facility:** Clinical Research Site

**State:** Missouri

**Status:** RECRUITING

**Zip:** 63304

**Location 12:**

**City:** Cherry Hill

**Country:** United States

**Facility:** Clinical Research Site

**State:** New Jersey

**Status:** RECRUITING

**Zip:** 08002

**Location 13:**

**City:** Raleigh

**Country:** United States

**Facility:** Clinical Research Site

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 27607

**Location 14:**

**City:** Memphis

**Country:** United States

**Facility:** Clinical Research Site

**State:** Tennessee

**Status:** RECRUITING

**Zip:** 38119

**Location 15:**

**City:** Austin

**Country:** United States

**Facility:** Clinical Research Site

**State:** Texas

**Status:** RECRUITING

**Zip:** 73787

**Location 16:**

**City:** San Antonio

**Country:** United States

**Facility:** Clinical Research Site

**State:** Texas

**Status:** RECRUITING

**Zip:** 78229

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Axsome Therapeutics Website

**URL:** http://www.axsome.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- ID: D000006963

- Term: Hyperphagia

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M5304

- Name: Bulimia

- Relevance: HIGH

- As Found: Binge Eating

- ID: M28641

- Name: Binge-Eating Disorder

- Relevance: HIGH

- As Found: Binge Eating Disorder

- ID: M26956

- Name: Bulimia Nervosa

- Relevance: LOW

- As Found: Unknown

- ID: M4380

- Name: Feeding and Eating Disorders

- Relevance: HIGH

- As Found: Eating Disorders

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10014

- Name: Hyperphagia

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002032

- Term: Bulimia

- ID: D000001068

- Term: Feeding and Eating Disorders

- ID: D000056912

- Term: Binge-Eating Disorder

### Intervention Browse Module - Browse Branches

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M12575

- Name: Norepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
