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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA |
| |
| Cohort 2: Unexposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA |
| |
| Cohort 3: Other-exposed participants with narcolepsy or OSA | Pregnant women with a diagnosis of narcolepsy or OSA |
| |
| Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA | Pregnant women without a diagnosis of narcolepsy or OSA |
| |
| Cohort 5: Other-exposed participants without narcolepsy or OSA | Pregnant women without a diagnosis of narcolepsy or OSA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunosi (solriamfetol) | Drug | Exposure to at least 1 dose of solriamfetol at any time during pregnancy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Safety | Baseline up to 12 months after pregnancy outcome |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 1-877-283-6220 | sunosipregnancyregistry@ppd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidera, a PPD business unit | Recruiting | Morrisville | North Carolina | 27560 | United States | |
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| Label | URL |
|---|---|
| Axsome Therapeutics Website | View source |
| Sunosi Pregnancy Registry Recruitment Website | View source |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
| D000697 | Central Nervous System Stimulants |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
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| Other prescription wake-promoting medications or stimulants | Drug | Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy. |
|
| No treatment | Other | No treatment |
|
| PPD, Inc. |
| Recruiting |
| Wilmington |
| North Carolina |
| 28401 |
| United States |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D045506 | Therapeutic Uses |