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)

• Status: Recruiting
• Trial end date: 2024-10-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ignis Therapeutics (Suzhou) Limited

Criteria

Inclusion Criteria:

1. Male or female between 18 and 75 years of age, inclusive.

2. Diagnosis of OSA according to ICSD-3 criteria.

3. Patients with OSA, regardless of whether they have received primary OSA therapy (i.e., positive airway pressure [PAP], oral negative pressure therapy, oral appliance or upper airway stimulator, or a history of OSA surgery), may be considered for enrollment:

1. Patients who are currently being treated with a primary OSA therapy (i.e., PAP, oral pressure therapy, oral appliance, or upper airway stimulator) at the frequency of at least 1 night per week, or

2. Patients who have a 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 or those who have never tried and refused primary OSA therapy, or

3. Patients who have a history of a surgical intervention intended to treat OSA symptoms.

4. Subject report (with clinician concurrence) of a stable level of compliance with a primary OSA therapy for at least 1 month prior to Baseline as follows:

1. A stable level of use of a primary OSA therapy, or

2. A lack of use of a primary OSA therapy following a history of attempted use or never attempt, or

3. A history of a surgical intervention intended to treat OSA symptoms.

5. Baseline Epworth Sleepiness Scale (ESS) score ≥10.

6. Baseline mean sleep latency <30 minutes as documented by the mean of the first four trials of the MWT.

7. Usual nightly total sleep time of at least 6 hours.

8. Body mass index from 18 to <45 kg/m2.

9. Consent to use a medically acceptable method of contraception during the screening period and baseline period, throughout the entire study period, and for 30 days after the study is completed.

10. Willing and able to provide written informed consent and comply with the study design schedule and other requirements.

11. Confirmation that the patient is currently in a medically stable state based on medical history inquiry, physical examination, laboratory tests, electrocardiogram examination, and review of concurrent medication.

Exclusion Criteria:

Subjects who demonstrate any of the following will be excluded from the study.

1. Female subjects who are pregnant, nursing, or lactating.

2. Usual bedtime later than 1 AM (0100 hours).

3. Occupation requiring nighttime shift work or variable shift work.

4. Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness.

5. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders（including suicidal ideation）according to DSM-5 criteria.

6. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator.

7. History of bariatric surgery within the past year or a history of any gastric bypass procedure.

8. Presence of renal impairment or calculated creatinine clearance <60 mL/min，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.

9. Clinically significant ECG abnormalities and ineligibility for participation in this study, as judged by the investigator, at screening.

10. Presence of significant cardiovascular disease including but not limited to:

myocardial infarction within the past year, unstable angina pectoris, symptomatic congestive heart failure (ACC/AHA stage C or D), revascularization procedures within the past year, ventricular cardiac arrhythmias requiring an automatic implantable cardioverter defibrillator (AICD) or medication therapy, uncontrolled hypertension, systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥95 mmHg (at screening, or consistently across Baseline measures according to protocol specifications), or any history of cardiovascular disease or any significant cardiovascular condition that in the investigator's opinion may jeopardize subject safety in the study.

11. Laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, and urinalysis)

12. Excessive caffeine use one week prior to Baseline assessments or anticipated excessive use during the study defined as >600 mg/day of caffeine.

13. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness within a time period prior to the Baseline Visit corresponding to at least five half-lives of the drug(s) or planned use of such drug(s) at some point throughout the duration of the study. Examples of excluded medications include OTC sleep aids or stimulants (e.g., pseudoephedrine), methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, pemoline, trazodone,hypnotics, benzodiazepines, barbiturates, and opioids.Medications should be discontinued such that the subject has returned to his/her baseline level of daytime sleepiness at least 7 days prior to the Baseline visit, in the opinion of the Investigator.

14. Use of a monoamine oxidase inhibitor (MAOI) in the past 14 days or five half-lives (whichever is longer) prior to the Baseline Visit, or plans to use an MAOI during the study.

15. Received an investigational drug or device in the past 30 days or five half-lives (whichever is longer) prior to the Baseline Visit, or plans to use an investigational drug or device(other than the study drug) during the study.

16. Previous exposure to or participation in a clinical trial of solriamfetol, or previous use of solriamfetol.

17. Current or past (within the past 2 years) diagnosis of a moderate or severe substance use disorder according to DSM-5 criteria.

18. Nicotine dependence that has an effect on sleep (e.g., a subject who routinely awakens at night to smoke).

19. Urine drug screen positive for an illicit drug of abuse (including cannabinoids) at screening or at any point throughout the duration of the study, except for a prescribed drug (e.g., amphetamine) at screening.

20. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products.

21. Vaccination within 31 days prior to the baseline or a plan for vaccination during the trial.

22. Subjects participating in this study is not in line with the rights and interests, or other circumstances that are not suitable for the subjects to participate in the study, as judged by the investigator.

23. Positive for human immunodeficiency virus antibodies or syphilis spiral antibodies.