A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to… (NCT06103825) | Clinical Trial Compass
CompletedPhase 3
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)
China204 participantsStarted 2023-08-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female between 18 to 75 years of age, inclusive.
✓. Diagnosis of OSA according to the International Classification of Sleep Disorders, 3rd edition (ICSD-3) criteria.
✓. Patients with OSA may be considered for enrollment if they meet one of the following criteria:
✓. Use of a primary therapy for OSA (i.e., positive airway pressure (PAP), oral pressure therapy, oral appliance, or upper airway stimulator) on at least 1 night per week, or
✓. History of at least 1 month of an attempt to use one or more primary OSA therapies with at least one documented adjustment that was made in an attempt to optimize the primary OSA therapy, or participants who have never used and refuse to use a primary OSA therapy, or
✓. History of a surgical intervention intended to treat OSA symptoms.
✓. A stable level of compliance with a primary OSA therapy for at least 1 month prior to the baseline visit as follows:
✓. A stable level of use of a primary OSA therapy, or
Exclusion criteria
✕. Female participants who are pregnant or lactating.
✕. Usual bedtime later than 1 a.m. (01:00).
✕. Occupation requiring nighttime shift work or variable shift work.
✕
What they're measuring
1
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)
Timeframe: From enrollment to the end of treatment at 12 weeks
2
To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 12 in ESS scores
Timeframe: From enrollment to the end of treatment at 12 weeks
. Any other clinically relevant medical, behavioral, or psychiatric disorders other than OSA that is associated with excessive sleepiness.
✕. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorder, or other psychotic disorders according to DSM-5 criteria, or presence of significant suicidality.
✕. History or presence of any acutely unstable medical condition, behavioral or cognitive impairment, or any medical condition or surgical history that could affect the safety of the participant or interfere with study efficacy, safety and PK assessments, or the ability of the participant to complete the study per the judgment of the investigator.
✕. History of the bariatric surgery within the past year or a history of any gastric bypass procedure.
✕. Presence of renal impairment or calculated creatinine clearance less than 60 mL/min at screening, which is calculated using the following formula: CLcr (mL/min) = (140 - age \[years\]) x body weight (kg) x (0.85, if female))/(72 x serum creatinine value \[mg/dL\]), if serum creatinine is expressed in µmol/L, the value should be divided by 88.4 to convert µmol/L to mg/dL.