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

NCT ID: NCT06311864

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-10-31

Brief 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.

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.

Conditions

Insomnia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

daridorexant

Patients who have been newly prescribed oral tablets of daridorexant 50 mg to treat their insomnia

Daridorexant 50 mg

Intervention Type: DRUG

As indicated by the physician

Interventions

Daridorexant 50 mg

As indicated by the physician

Intervention Type: DRUG

Other Intervention Names

QUVIVIQ

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: collaborator

PeriPharm

OTHER

Sponsor Role: lead

Responsible Party

Jean Lachaine

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean Lachaine, PhD

Role: PRINCIPAL_INVESTIGATOR

PeriPharm

Locations

PROxy Network, an initiative of PeriPharm inc.

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

PROxy240215

Identifier Type: -

Identifier Source: org_study_id