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Sleep Apnea, ObstructivePhase 3NCT06103825

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)

A Phase 3 study testing Solriamfetol in people with Sleep Apnea, Obstructive and Excessive Daytime Sleepiness, run by Ignis Therapeutics (Suzhou) Limited at 26 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Solriamfetol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
26 sitesChina
Study dates
1 Aug 2023to 19 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • A lack of use of a primary OSA therapy either following a history of attempted use, or have never used before, or
  • A history of a surgical intervention intended to treat OSA symptoms.
  • Baseline ESS score no less than 10 points (≥ 10 points).
  • Baseline MWT mean sleep latency < 30 minutes (documented by the mean of the first four 40-minute trials of the MWTs).
  • Usual nightly total sleep time of at least 6 hours (≥ 6 hours).
  • Body mass index (BMI) from18 kg/m2 to < 45 kg/m2.
  • Female participants must have negative pregnancy test results at the screening and baseline visits; all participants must consent to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the study is completed.
  • Willing and able to provide written informed consent, willing and able to comply with the study protocol (i.e., must be able to understand and complete the study questionnaires and scales, comply with the visit schedule and prescribed dosage regimens).
  • Determined by the investigator to be medically stable as assessed by medical history, physical examination, laboratory and electrocardiogram test results and review of concomitant medications.

Who cannot join

  • 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.
  • 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.
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  • 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.
  • Clinically significant ECG abnormality in the opinion of the investigator would preclude participation in the study.
  • Presence of significant cardiovascular disease at screening, including but not limited to: myocardial infarction within the past year, unstable angina pectoris, symptomatic congestive heart failure [(American College of Cardiology/American Heart Association (ACC/AHA) Stage C or D)], revascularization procedures within the past year, ventricular cardiac arrhythmia 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 across Baseline measures according to protocol specifications), or any significant cardiovascular condition that in the investigator's opinion may jeopardize participant's safety in the study.
  • Laboratory value(s) outside the laboratory reference range that are considered to be clinically significant and may affect the safety of the participant per the judgment of the investigator (including clinical chemistry, hematology, and urinalysis) (Note: Screening labs may be repeated once).
  • Excessive caffeine use one week prior to the baseline assessments, or anticipated excess caffeine use during the study, defined as greater than 600 mg caffeine per day (>600 mg/day).
  • 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, 2-acetamide, sodium oxybate, pemoline, trazodone, hypnotics, benzodiazepines, barbiturates, and opioids, and any traditional Chinese medicine that may affect sleep. Medications should be discontinued such that the participant 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.
  • 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.
  • 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 (other than the investigational drug) or investigational medical devices during the study
  • Previous exposure to or participation in a clinical trial of solriamfetol.
  • Current or past (within the past 2 years prior to screening) diagnosis of a moderate or severe substance use disorders according to DSM-5 criteria or seeking treatment for a substance related disorder.
  • Nicotine dependence that has an effect on sleep (e.g., a participant who routinely awakened at night to smoke).
  • 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 prescriped drug (e.g., amphetamines) at screening.
  • History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products.
  • Vaccination within 31 days prior to the baseline visit or a plan for vaccination during the study.
  • Any other conditions that are not in line with the rights and interests of the participants or would preclude participation in the study as judged by the investigator.
  • Human Immunodeficiency Virus (HIV) or syphilis positive at screening

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

China26 sites

  • Beijing TianTan Hospital Capital Medical University

    Beijing

  • China-Japan friendship Hospital

    Beijing

  • Peking University Sixth Hospital

    Beijing

  • XuanWu Hospital Capital Medical University

    Beijing

  • The first hospital of Jilin University

    Changchun

  • Xiangya Hospital Central South University

    Changsha

  • ChongQing University three gorges Hospital

    Chongqing

  • The Hospital Group of the First Affiliated Hospital of CQMU

    Chongqing

  • GanSU Provincial Hospital

    Gansu

  • The first affiliated hospital of Guangzhou Medical University

    Guangzhou

  • The first affiliated hospital of JiNan University

    Guangzhou

  • Hangzhou seventh People's Hospital

    Hangzhou

  • The first hospital of Hebei Medical University

    Hebei

  • Huai'an First People's Hospital

    Huai'an

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

  • The Fitst Affiliated Hospital of NingBo University

    Ningbo

  • ShanDong Provincial QianFoShan Hospital

    Shandong

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

  • HuaShan Hospital FuDan University

    Shanghai

  • First hospital of ShanXi Medical University

    Shanxi

  • Second hospital of Shanxi Medical University

    Shanxi

  • ShenZhen People's Hospital

    Shenzhen

  • West China fourth Hospital Sichuan University

    Sichuan

  • The Second Affiliated Hospital of Suzhou University

    Suzhou

  • Yan'an University Xianyang Hospital

    Xianyang

  • The First People's Hospital of YunNan Province

    Yunnan

Other trials in China

About this study

Official title: A Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Treatment with Solriamfetol in Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea Syndrome (OSA) with a 12-week Treatment Period

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.

Being tested
Solriamfetol, Placebo
Medical subject headings
Sleep Apnea, Obstructive, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SolriamfetolDrug

    solriamfetol : QD，PO，Day 1-Day 84；

  • PlaceboDrug

    Placebo :QD，PO，Day 1-Day 84

Study groups in NCT06103825
Study groupRoleWhat they receive
Strengths of solriamfetol (JZP-110) strengths: 37.5 mg，75 mg, 150 mgExperimentalsubject 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.
Receives: Drug: Solriamfetol
matching PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Change from baseline in mean MWT sleep latency (minutes, determined from the first four 40-minute trials of the MWT) to Week 12

    Measured: 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

    Change from baseline in ESS total score to Week 12 Epworth Sleepiness Scale (ESS): ESS score ranges from 0 to 24 (inclusive), with higher score denoting greater degrees of sleepiness

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (7)

  1. Key Secondary Study Objective: To compare treatment with solriamfetol versus placebo on the percentage of participants reported as improved (minimally, much, very much) in PGIc at Week 12 among patients with OSA

    Percentage of participants with improved PGIc at Week 12

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Other Secondary Study Objective 1:To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 2 and Week 5 in the mean MWT sleep latency

    Changes from baseline in MWT at the end of the Week 2 and Week 5 are defined as: mean sleep latency at the end of the Week 2 and Week 5 (determined from the first four 40-minute trials of the MWTs) minus the baseline measurement (minutes)

    Measured: From enrollment to the end of treatment at the 2- and 5-week

  3. Other Secondary Study Objective 2: To evaluate the effect of solriamfetol compared to placebo among patients with OSA in change from baseline to Week 2, 5 and 8 in ESS score

    Changes from baseline in ESS scores at the end of Week 2, 5 and 8 are defined as: ESS total scores at the end of Week 2, 5 and 8 minus baseline values Epworth Sleepiness Scale (ESS): ESS score ranges from 0 to 24 (inclusive), with higher score denoting greater degrees of sleepiness

    Measured: From enrollment to the end of treatment at the 2- ,5- and 8-week

  4. Other Secondary Study Objective 3: To compare treatment with solriamfetol versus placebo on the percentage of participants reported as improved (minimally, much, very much) in PGIc at Week 2, 5 and 8 among patients with OSA

    The percentages of participants reported as improved (minimally, much, very much) in PGIc at Week 2, 5 and 8 are defined as the percentages calculated by dividing the number of participants reported as improved in PGIc by the total number of participants in the each treatment group at Week 2, 5 and 8

    Measured: From enrollment to the end of treatment at the 2- ,5- and 8-week

  5. Other Secondary Study Objective 4: To compare treatment with solriamfetol versus placebo on the percentage of participants rated as improved (minimally, much, very much) in CGIc at Week 12 among patients with OSA

    The percentage of participants rated as improved (minimally, much, very much) in CGIc at the end of Week 12 is defined as the percentage calculated by dividing the number of participants who have achieve improvement (minimally, much, very much) in CGIc by the total number of participants in each treatment group at Week 12

    Measured: From enrollment to the end of treatment at 12 weeks

  6. Other Secondary Study Objective 5: To compare treatment with solriamfetol versus placebo on the percentage of participants rated as improved (minimally, much, very much) in CGIc at Week 2, 5 and 8 among patients with OSA

    The percentage of participants rated as improved (minimally, much, very much) in CGIc at the end of Week 12 is defined as the percentage calculated by dividing the number of participants who have achieve improvement (minimally, much, very much) in CGIc by the total number of participants in each treatment group at Week 2, 5 and 8

    Measured: From enrollment to the end of treatment at the 2- ,5- and 8-week

  7. Other Secondary Study Objective 6: To compare the efficacy of solriamfetol versus placebo throughout the day in sleep latency for each of the 5 MWT trials

    Changes of the efficacy throughout the day in MWT: changes in sleep latency for each of the 5 MWTs (minutes)

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2023
  2. Study start1 Aug 2023
  3. Primary completion20 Jul 2024
  4. Study completion19 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06103825
Sponsor's protocol ID
IGN-B0301-03
Status last verified
Oct 2024
First submitted
27 Sep 2023
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cheng H, Deng L, Meng Z, Zhang W, Chen T, Chen R, Tang S, Lv Y, Su X, Liu Z, Zhang X, Wang X, Mao H, Zhang N, Yu H, Pan J, Xie Y, Tang J, Yin S, Wang Z, Tong M, Zhan S, Wang C, Wang B, Zhang W, Mi W, Lu L. Efficacy and Safety of Solriamfetol on Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea in China: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial. CNS Drugs. 2026 Jan;40(1):83-98. doi: 10.1007/s40263-025-01232-1. Epub 2025 Oct 23.

    PubMed 41128833

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Solriamfetol in people with Sleep Apnea, Obstructive and Excessive Daytime Sleepiness, run by Ignis Therapeutics (Suzhou) Limited at 26 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06103825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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