A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT05597020
Phase
PHASE4
Status
Completed

Conditions

  • Insomnia Disorder
  • Nocturia

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant — DRUG
    Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
  • Placebo — DRUG
    Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.

Study Details

A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia

Key Dates

Start date
Feb 16, 2023
Status verified
Apr 2025
Primary completion
Apr 12, 2024
Completion
Apr 18, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 50 mg daridorexant
    Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.
  • Placebo Comparator: Placebo
    Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.

Primary Outcome Measure

Change From Baseline to Week 4 in sTST [ Time Frame: From baseline to Week 4 per treatment period. ]

Locations (5)

FacilityCityStateZIPSite coordinators
Quantum Clinical TrialsMiami BeachFlorida33140-
Clinical Research Center of FloridaPompano BeachFlorida33060-
Encore Medical Research of WestonWestonFlorida33331-
Ochsner LSU Health Shreveport-Regional UrologyShreveportLouisiana71106-
Accellacare Research of CaryCaryNorth Carolina27518-

Find similar trials in Miami Beach, FL

By research site
Quantum Clinical Trials· Miami Beach, FLClinical Research Center of Florida· Pompano Beach, FLEncore Medical Research of Weston· Weston, FLOchsner LSU Health Shreveport-Regional Urology· Shreveport, LAAccellacare Research of Cary· Cary, NC

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