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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Retrospective study to collect existing data from patients with insomnia disorder and comorbid restless leg syndrome who are already treated with QUVIVIQ in neurological or sleep centres as part of their routine standard of care.
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective data collection

Study drug and medical condition

• Medicinal product name:
  QUVIVIQ
• Study drug International non-proprietary name (INN) or common name:
  DARIDOREXANT HYDROCHLORIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (N05CJ03) daridorexant

  daridorexant
• Medical condition to be studied:
  Insomnia

  Restless legs syndrome

Population studied

• Short description of the study population:
  The participants have been diagnosed with insomnia disorder and comorbid restless legs syndrome. This patient population is routinely seen in participating neurological or sleep centres in the countries where the study will be conducted.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  90

Study design details

• Study design:
  • Study design: multi-centre, retrospective, non-interventional study with no control group.; • Data collection: existing patient data found in medical records.; • Participants: patients who have received QUVIVIQ for at least 4 weeks for insomnia disorder with comorbid restless legs syndrome.
• Main study objective:
  The main study objective is to describe the effects of QUVIVIQ in patients with insomnia disorder and comorbid restless legs syndrome (RLS), as follows:; • The safety of QUVIVIQ when used in patients with insomnia disorder and comorbid RLS in a real-world setting.; • The efficacy of QUVIVIQ in treating insomnia in patients with insomnia disorder and comorbid RLS in a real-world setting. ; • The effect of QUVIVIQ on RLS severity in patients with insomnia disorder and comorbid RLS in a real-world setting.;
• Setting:
  Study periods; (1) Baseline period: 15-week period prior to and including the date QUVIVIQ was first prescribed to the participant.; (2) Observation period: The period from the day after QUVIVIQ was first prescribed to the participant, lasting a minimum of 4 weeks and maximum of 15 weeks. Ends with the signing of the informed consent form (ICF).; ; Patient population; • Aged ≥ 18 years at the date of first prescription of QUVIVIQ.; • Diagnosed with insomnia disorder, characterised by difficulty initiating and/or maintaining sleep, and/or early morning awakenings, occurring 3 or more nights per week for at least 3 months with daytime symptoms.; • Diagnosed with comorbid, clinically stable, restless legs syndrome (RLS), with no change in RLS medication during the 3 months prior to initiation of QUVIVIQ and no signs of augmentation.; • Prescribed QUVIVIQ 50 mg at least 4 weeks prior to signing the ICF.; • Clinically assessed while treated with QUVIVIQ at least once between 4 and 15 weeks after first prescription of QUVIVIQ.;
• Outcomes:
  Data collection will include variables assessed or measured as part of standard clinical care as per local practice. Data will not be generated for the sole purpose of the study.; ; Endpoint definitions; • Safety: All relevant medical events that occur from baseline to the last clinical on-treatment assessment between 4 and 15 weeks after first prescription of QUVIVIQ. ; • Efficacy in treating insomnia: Change in Insomnia Severity Index© (ISI©) score from baseline to the last clinical on-treatment assessment between 4 and 15 weeks after first prescription of QUVIVIQ.; • Effect on restless legs syndrome (RLS) severity: Change in International Restless Legs Study Group Severity Rating Scale (IRLS) total or local score from baseline to the last clinical on-treatment assessment between 4 and 15 weeks after first prescription of QUVIVIQ.;
• Data analysis plan:
  Full analysis set; • All participants for whom informed consent was obtained and who received QUVIVIQ for at least 4 weeks. ; ; Change from baseline in Insomnia Severity Index© score and International Restless Legs Study Group Severity Rating Scale total score; • One-sample t-test (95% confidence intervals for the mean change). ; ; Adverse events (AEs); • Number and percentage of participants experiencing any AE during the baseline period (i.e., AEs starting prior to and including the first prescription date of QUVIVIQ). ; • Number and percentage of participants experiencing any AE during the observation period (i.e., from the day after QUVIVIQ was first prescribed to the participant: a minimum of 4 weeks to a maximum of 15 weeks).;