Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strengths of solriamfetol (JZP-110) strengths: 37.5 mg,75 mg, 150 mg | Experimental | 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. |
|
| matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solriamfetol | Drug | solriamfetol : QD,PO,Day 1-Day 84; |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 12 weeks |
| 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 | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 12 weeks |
Not provided
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:
A stable level of compliance with a primary OSA therapy for at least 1 month prior to the baseline visit as follows:
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.
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | China | |||
| Beijing TianTan Hospital Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41128833 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo :QD,PO,Day 1-Day 84 |
|
| 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) |
| From enrollment to the end of treatment at the 2- and 5-week |
| 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 | From enrollment to the end of treatment at the 2- ,5- and 8-week |
| 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 | From enrollment to the end of treatment at the 2- ,5- and 8-week |
| 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 | From enrollment to the end of treatment at 12 weeks |
| 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 | From enrollment to the end of treatment at the 2- ,5- and 8-week |
| 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) | From enrollment to the end of treatment at 12 weeks |
| Beijing |
| China |
| China-Japan friendship Hospital | Beijing | China |
| Peking University Sixth Hospital | Beijing | China |
| XuanWu Hospital Capital Medical University | Beijing | China |
| The first hospital of Jilin University | Changchun | China |
| Xiangya Hospital Central South University | Changsha | China |
| ChongQing University three gorges Hospital | Chongqing | China |
| The Hospital Group of the First Affiliated Hospital of CQMU | Chongqing | China |
| GanSU Provincial Hospital | Gansu | China |
| The first affiliated hospital of Guangzhou Medical University | Guangzhou | China |
| The first affiliated hospital of JiNan University | Guangzhou | China |
| Hangzhou seventh People's Hospital | Hangzhou | China |
| The first hospital of Hebei Medical University | Hebei | China |
| Huai'an First People's Hospital | Huai'an | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | China |
| The Fitst Affiliated Hospital of NingBo University | Ningbo | China |
| ShanDong Provincial QianFoShan Hospital | Shandong | China |
| HuaShan Hospital FuDan University | Shanghai | China |
| First hospital of ShanXi Medical University | Shanxi | China |
| Second hospital of Shanxi Medical University | Shanxi | China |
| ShenZhen People's Hospital | Shenzhen | China |
| West China fourth Hospital Sichuan University | Sichuan | China |
| The Second Affiliated Hospital of Suzhou University | Suzhou | China |
| Yan'an University Xianyang Hospital | Xianyang | China |
| The First People's Hospital of YunNan Province | Yunnan | China |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000623308 | solriamfetol |
Not provided
Not provided
Not provided