Retrospective, non-interventional, multicenter study on the effectiveness and safety of QUVIVIQ in patients with insomnia disorder and comorbid restless legs syndrome.

Study identification

• EU PAS number:
  EUPAS1000000859
• Study ID:
  1000000859
• Official title and acronym:
  Retrospective, non-interventional, multicenter study on the effectiveness and safety of QUVIVIQ in patients with insomnia disorder and comorbid restless legs syndrome.
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  Study design; This is a multi-centre, retrospective, non-interventional study in patients treated with QUVIVIQ. Data will be collected retrospectively using only existing patient data found in medical records. ; ; Research question; Is QUVIVIQ safe and efficacious in patients with insomnia disorder and comorbid restless legs syndrome (RLS)?; ; Main objective; To describe the safety and efficacy of QUVIVIQ in patients with insomnia disorder and comorbid RLS in a real-world setting.; ; Data sources; Patient data will be collected from existing medical records by participating sites, i.e., medical charts / electronic medical records, including patient self-reports/surveys, tests, and assessments.; ; Recruitment strategy; The investigators involved in the study will inform their eligible patients of the study and request consent for data collection.;
• Study status:
  Planned

Research institutions and networks

Institutions

Idorsia Pharmaceuticals Ltd

Study timelines

Date when funding contract was signed

Planned:02/02/2026

Study start date

Planned:01/04/2026

Date of final study report

Planned:31/07/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Idorsia Pharmaceuticals Ltd

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable