Insomia Disorder
Conditions
Brief summary
The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder. The trial aims to find out whether daridorexant can help improve: * how trial participants sleep at night, * how trial participants function the next day. Researchers will compare daridorexant to a placebo (a look-alike inactive substance that contains no active medicine) to understand which effect daridorexant has on total sleep time and next-day functioning. Enrolled participants will: * Take daridorexant 50 mg or placebo once daily for approximately 3 months * Visit the clinic once every month during treatment for checkups and tests * Keep a sleep diary of the number of hours they sleep and how well they sleep * Complete a questionnaire every day about any symptoms of sleepiness during the day and any impact on physical and mental functioning such as energy levels, mood, or ability to concentrate or memorize.
Detailed description
The trial includes three trial periods: Following a Screening period, during which it will be checked if participants are eligible to take part, eligible participants will be randomized in a 1:1 ratio to receive either daridorexant 50 mg or placebo for ca. 3 months (Treatment period). On completion of treatment, participants will be followed for up to 10 days for safety assessments (Safety follow-up period). Trial participation will end with a Follow-up call (Participant Last Visit) at the end of the Safety follow-up period. The maximum trial duration for an individual participant will be approximately 4 months.
Interventions
DRUGDaridorexant
Daridorexant 50 mg tablets
DRUGPlacebo
Matching placebo tablets
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants aged ≥ 18 years at the time of signing the ICF * Insomnia disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders criteria including: Self-reported insufficient sleep quantity defined as subjective Total Sleep Time (TST) ≤ 6.5 hours during the night, associated with difficulties with sleep initiation or maintenance or early-morning awakenings, for at least 3 nights per week during a period of at least 3 months prior to screening visit * Insomnia Severity Index© score ≥ 15 * Presence of insomnia symptoms (TST ≤ 6.5 hours for at least 3 valid nights recording, and average TST ≤ 6.5 hours over 7 nights) confirmed by objective measurements using a home electroencephalogram (EEG) device over a 7-night period during screening * Adequate opportunity for sleep (time in bed ≥ 7 hours for at least 3 valid recorded nights) confirmed by objective measurements obtained using the home EEG device during the 7-night assessment period specified in the inclusion criterion above
Exclusion criteria
* Body mass index \< 18.5 or \> 40.0 kg/m2 * Any lifetime history of breathing-related sleep disorder * Presence of an additional sleep-wake disorder * Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week * Previous treatment with daridorexant or other dual orexin receptor antagonists at any time prior to Visit 1 * Acute or unstable (i.e., not adequately controlled for at least 1 month) psychiatric condition * Any suicidal ideation or history of suicide attempt, as assessed by Columbia Suicide Severity Rating Scale© (C-SSRS©), at Visit 1 * Unstable medical condition, which, in the opinion of the investigator, could affect the participant's safety or interfere with the trial assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to Month 3 in Subjective Total Sleep Time (sTST) | Baseline and Month 3 | Subjective Total Sleep Time (sTST) is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. A negative change from baseline indicates a decrease in sTST. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score (SDS) | Baseline and Month 3 | The IDSIQ is a validated patient-reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., Alert/Cognition, Mood, and Sleepiness) reflecting daytime impairment of insomnia. The SDS ranges from 0 to 40. A higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
| Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Total Score (TS) | Baseline and Month 3 | The IDSIQ comprises three domains: Alert/Cognition (maximum score: 60), Mood (maximum score: 40), and Sleepiness (maximum score: 40), resulting in a TS ranging from 0 to 140. A higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
Contacts
CONTACTIdorsia Clinical Trial Information USA
CONTACTIdorsia Clinical Trial Information Europe
STUDY_DIRECTORGlobal Clinical Development
Idorsia Pharmaceuticals Ltd.
Outcome results
None listed