Study identification

EU PAS number

EUPAS45651

Study ID

50596

Official title and acronym

A post-authorisation safety study (PASS) to evaluate cardiovascular events in adult patients with obstructive sleep apnoea (OSA) treated with solriamfetol (JZP865-401)

DARWIN EU® study

No

Study countries

France
Germany

Study description

Obstructive sleep apnoea (OSA) is a breathing condition when airways are narrowed due to muscle relaxation and can result in the airway obstruction and apnoea. Solriamfetol is indicated to reduce EDS in adult patients with narcolepsy or obstructive sleep apnea in whom EDS has not been satisfactorily treated by primary OSA therapy. Per EMA requirement, Jazz Pharmaceuticals/Axsome Therapeutics aims to carry out a PASS of solriamfetol in patients with OSA in Europe to assess the safety of the treatment and to evaluate MACE and other potential safety outcomes in adult patients. This study will be a prevalent new user cohort study using secondary data sources (claims/EHR) conducted in Germany and France, where solriamfetol has been marketed. The primary objective of this study is to estimate and compare the incidence rate of incident MACE, as a composite endpoint of: All cardiovascular (CV) mortality, non-fatal acute myocardial infarction, and non-fatal stroke, in adults newly exposed to solriamfetol plus positive airway pressure with patients exposed only to continuous PAP (C-PAP). The study population will be patients diagnosed with OSA at 18 years of age or greater and treated with C-PAP for at least one month with or without pharmacological intervention (solriamfetol or other wake-promoting agents). Main exposure will be solriamfetol and non-pharmacological intervention for airway obstruction (positive airway pressure). Secondary exposures will be the wake-promoting agents. The primary outcome will be a composite measure of MACE including All CV mortality, non-fatal acute MI, non-fatal stroke. Patients treated with solriamfetol plus C-PAP will be compared with patients exposed to C-PAP alone, adjusting for disease severity and known cardiovascular risk factors. Multivariable adjusted hazard ratio (HR) of MACE outcome will be measured comparing those exposed to solriamfetol (plus C-PAP) vs C-PAP only.

Study status

Planned
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner
Multiple centres: 2 centres are involved in the study

Contact details

Sofia Correia

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pharmanovia (Atnahs Pharma UK Ltd)
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)