A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)

Sponsor
Ignis Therapeutics (Suzhou) Limited
Study ID
NCT06103825
Phase
PHASE3
Status
Completed

Conditions

  • Excessive Daytime Sleepiness
  • Sleep Apnea, Obstructive

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Solriamfetol — DRUG
    solriamfetol : QD，PO，Day 1-Day 84；
  • Placebo — DRUG
    Placebo :QD，PO，Day 1-Day 84

Study Details

The purpose of this study is to evaluate the efficacy and safety of 12-week solriamfetol administration in the treatment of EDS in patients with OSA from China, using a randomized, double-blind, placebo-controlled, multi-center, parallel-design.

Key Dates

Start date
Aug 1, 2023
Status verified
Oct 2024
Primary completion
Jul 20, 2024
Completion
Aug 19, 2024

Study Design

Enrollment
204 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Strengths of solriamfetol (JZP-110) strengths: 37.5 mg，75 mg, 150 mg
    subject will first enter a 2-week Titration Phase, during which the initial dose will be 37.5mg. The dose will be increased from 37.5mg QD to 75mg QD after 3 days, and then to 150mg QD at the first day of the second week if well-tolerated. subjects will then enter the 10-week Maintenance Phase on 150mg QD if well-tolerated. If a subject tolerability issues after titration up to 150mg at the second week, the dose can be reduced to 75mg QD following instructions of the investigators. This subject will then enter the 10-week Maintenance Phase on 75mg QD. If a subject experiences tolerability issues after titration up to 75mg at the first week, the dose can be reduced to 37.5mg QD following instructions of the investigators. The dose will be increased to 75mg QD again at the first day of the second week. Subject will then enter the 10-week Maintenance Phase on 75mg QD if well-tolerated. All subjects should be maintained on either 75mg QD or 150mg QD during the Maintenance Phase.
  • Placebo Comparator: matching Placebo

Primary Outcome Measure

To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 12 in the mean MWT sleep latency (minutes, (determined from the first four 40-minute trials of the MWT) [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

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