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

Last updated: March 12, 2025
Sponsor: PeriPharm
Overall Status: Active - Enrolling

Phase

N/A

Condition

Insomnia

Treatment

Daridorexant 50 mg

Clinical Study ID

NCT06311864
PROxy240215
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed ICF prior to any study-mandated procedure.

  • Has received a first prescription of daridorexant 50 mg to treat insomnia, treatmentstart has not exceeded 7 days prior to enrollment.

  • Ability to read and understand French or English.

Exclusion

Exclusion Criteria:

  • Patients participating in a clinical trial.

  • History of daridorexant use in the past (i.e., samples provided by the physicianbefore prescription).

  • Taking a concomitant medication to treat insomnia.

  • Already started daridorexant more than 7 days prior to enrollment.The 7-day periodis necessary to allow flexibility between the time of prescription and PROxy firstcontact to participant. Beyond this 7-day period, patients may already haveexperienced benefits from daridorexant. To minimize bias in baseline results, thesepatients will be excluded.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Daridorexant 50 mg
Phase:
Study Start date:
June 20, 2024
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • PROxy Network, an initiative of PeriPharm inc.

    Montreal, Quebec H2Y 2H4
    Canada

    Site Not Available

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