Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada

The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Drug: Daridorexant 50 mg

Detailed Description

Participating physicians will identify potential participants based on their medical judgment for a new prescription of QUVIVIQ® (daridorexant) 50 mg. Physicians will discuss with the potential participant in person to briefly describe the study (purpose, confidentiality, questionnaires, as well as compensation). Potential participants interested in participating in the study will be asked to give their authorization to share with the PROxy Network their contact information by signing an authorization form. A designated PROxy team member will then contact the potential participant to explain the study in more details and to assess the eligibility. If the potential participant agrees to participate and provides verbal consent, he/she will be invited to visit the Participant Portal on the PROxy website to sign the ICF and complete the online baseline questionnaires.

Five days prior to each study timepoint (1 month, 2 months and 3 months following baseline questionnaire completion), participants will receive an email inviting them to fill their study questionnaires. This e-mail will be sent every other day to the participant who have not completed the questionnaires. In the case where a participant has not completed the questionnaires within a period of 5 days after the first email was sent, a call will be made by a designated PROxy team member to remind the patient to complete the questionnaire. Participants who don't complete the questionnaires in the 5 days following the call will be excluded from this timepoint analysis.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jean Lachaine, PhD; Phone Number: 101 514-731-8207; Email: jean.lachaine@peripharm.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2Y 2H4
      • PROxy Network, an initiative of PeriPharm inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients identified by 10 participating physicians in 4 provinces across Canada (Quebec, Ontario, Alberta, British Columbia)

Description

Inclusion Criteria:

• Signed ICF prior to any study-mandated procedure.
• Has received a first prescription of daridorexant 50 mg to treat insomnia, treatment start has not exceeded 7 days prior to enrollment.
• Ability to read and understand French or English.

Exclusion Criteria:

• Patients participating in a clinical trial.
• History of daridorexant use in the past (i.e., samples provided by the physician before prescription).
• Taking a concomitant medication to treat insomnia.
• Already started daridorexant more than 7 days prior to enrollment.The 7-day period is necessary to allow flexibility between the time of prescription and PROxy first contact to participant. Beyond this 7-day period, patients may already have experienced benefits from daridorexant. To minimize bias in baseline results, these patients will be excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
daridorexant; Patients who have been newly prescribed oral tablets of daridorexant 50 mg to treat their insomnia	Drug: Daridorexant 50 mg; As indicated by the physician; Other Names: QUVIVIQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Quality of Life	QoL will be measured using the SF-36 questionnaire, a self-administered and validated questionnaire. The percentage change from baseline in each domain of the SF-36 will be assessed at Month 1, Month 2 and Month 3.	Month 1, Month 2, Month 3
Change from Baseline in Work Productivity Loss	Work productivity loss will be measured using the Work Productivity and Activity Impairment for Specific Health Problem (WPAI:SHP), a self-administered and validated 6-item questionnaire designed to assess the impact of a health condition on work productivity and daily activities for a specific disease/condition (in this case, insomnia). The percentage change from baseline on the WPAI:SHP score at month 1, month 2 and month 3 will be assessed.	Month 1, Month 2, Month 3
Change from Baseline in the Severity of Insomnia Symptoms	Severity of insomnia symptoms will be measured using the Insomnia Severity Index (ISI) questionnaire, a self-administered, validated, 7-item questionnaire, designed to assess the severity of insomnia symptoms. The ISI will be assessed at Month 1, Month 2, and Month 3.	Month 1, Month 2, Month 3

Collaborators and Investigators

• Sponsor: PeriPharm
• Collaborators: Idorsia Pharmaceuticals Ltd.
• Investigators: Principal Investigator: Jean Lachaine, PhD, PeriPharm

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; insomnia; observational; real-world; work productivity; daridorexant; dual orexin receptor antagonist
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: PROxy240215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No