## Protocol Section
### Identification Module
**NCT ID:** NCT06413420

**Brief Title:** SUNOSI® (Solriamfetol) Pregnancy Registry

**Official Title:** SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring

#### Organization Study ID Info
**ID:** JZP110-402
#### Organization
**Class:** INDUSTRY
**Full Name:** Axsome Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2029-09

**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:** 2029-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-07-31

**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:** The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).

**Detailed Description:** The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions.

The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.

### Conditions Module

**Conditions:**

- Narcolepsy

- Obstructive Sleep Apnea

- Pregnant Women and Their Offspring

**Keywords:**

- Solriamfetol

- SUNOSI

- Axsome

- Narcolepsy

- Obstructive Sleep Apnea

- Non-stimulant therapy

- Dopamine norepinephrine reuptake inhibitor

- Pregnancy outcomes

- Infant outcomes

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1731

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 12 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** Pregnant women with a diagnosis of narcolepsy or OSA

**Intervention Names:**

- Drug: Sunosi (solriamfetol)

**Label:** Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA

#### Arm Group 2

**Description:** Pregnant women with a diagnosis of narcolepsy or OSA

**Intervention Names:**

- Other: No treatment

**Label:** Cohort 2: Unexposed participants with narcolepsy or OSA

#### Arm Group 3

**Description:** Pregnant women with a diagnosis of narcolepsy or OSA

**Intervention Names:**

- Drug: Other prescription wake-promoting medications or stimulants

**Label:** Cohort 3: Other-exposed participants with narcolepsy or OSA

#### Arm Group 4

**Description:** Pregnant women without a diagnosis of narcolepsy or OSA

**Intervention Names:**

- Drug: Sunosi (solriamfetol)

**Label:** Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA

#### Arm Group 5

**Description:** Pregnant women without a diagnosis of narcolepsy or OSA

**Intervention Names:**

- Drug: Other prescription wake-promoting medications or stimulants

**Label:** Cohort 5: Other-exposed participants without narcolepsy or OSA

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA

- Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA

**Description:** Exposure to at least 1 dose of solriamfetol at any time during pregnancy.

**Name:** Sunosi (solriamfetol)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Cohort 3: Other-exposed participants with narcolepsy or OSA

- Cohort 5: Other-exposed participants without narcolepsy or OSA

**Description:** Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.

**Name:** Other prescription wake-promoting medications or stimulants

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Cohort 2: Unexposed participants with narcolepsy or OSA

**Description:** No treatment

**Name:** No treatment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Long-term Safety

**Time Frame:** Baseline up to 12 months after pregnancy outcome

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Pregnant women of any age
* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy
* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
* Provides written informed consent to participate in the study
* Authorization for her HCP(s) to provide data to the registry

Exclusion Criteria:

* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
* Inclusion of a prior pregnancy in the main analysis population

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** The study population will include pregnant women of any age who reside in a country where solriamfetol is available for the treatment of narcolepsy or OSA, provide consent to participate as well as medical releases for their healthcare providers (HCPs) to provide data to the registry, and meet the criteria for inclusion into 1 of the 5 cohorts.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sunosipregnancyregistry@ppd.com

**Name:** Study Director

**Phone:** 1-877-283-6220

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Morrisville

**Country:** United States

**Facility:** Evidera, a PPD business unit

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 27560

**Location 2:**

**City:** Wilmington

**Country:** United States

**Facility:** PPD, Inc.

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 28401

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Axsome Therapeutics Website

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

**Label:** Sunosi Pregnancy Registry Recruitment Website

**URL:** https://sunosipregnancyregistry.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001049

- Term: Apnea

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006970

- Term: Disorders of Excessive Somnolence

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4361

- Name: Apnea

- Relevance: LOW

- As Found: Unknown

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: HIGH

- As Found: Sleep Apnea

- ID: M22010

- Name: Sleep Apnea, Obstructive

- Relevance: HIGH

- As Found: Obstructive Sleep Apnea

- ID: M12241

- Name: Narcolepsy

- Relevance: HIGH

- As Found: Narcolepsy

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M1717

- Name: Sleepiness

- Relevance: LOW

- As Found: Unknown

- ID: M10021

- Name: Disorders of Excessive Somnolence

- 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: T4044

- Name: Narcolepsy

- Relevance: HIGH

- As Found: Narcolepsy

### Condition Browse Module - Meshes

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000020181

- Term: Sleep Apnea, Obstructive

- ID: D000009290

- Term: Narcolepsy

### Intervention Browse Module - Ancestors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: HIGH

- As Found: Reader

- ID: M12575

- Name: Norepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000697

- Term: Central Nervous System Stimulants

### Misc Info Module

- Version Holder: 2024-05-31
