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Insomnia DisorderPhase 2NCT06680505

Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder

A Phase 2 study testing YZJ-1139 10mg, YZJ-1139 20mg and YZJ-1139 40mg in people with Insomnia Disorder, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 33 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 main purpose of this study is to evaluate the efficacy and safety of YZJ-1139 in the short-term treatment of primary chronic insomnia, explore the optimal effective dose, and provide the basis for phase III clinical trials Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Insomnia Disorder
What is being tested?
YZJ-1139 10mg, YZJ-1139 20mg and YZJ-1139 40mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
33 sitesChina
Study dates
4 Aug 2019to 29 Mar 2021
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 to < 65 years.
  • Meet the clinical diagnostic criteria for primary chronic insomnia disorder as defined in ICSD-3 criteria.
  • PSG results for 2 consecutive nights during the run-in period should meet the following conditions:
  • 1) The mean LPS of 2 nights is ≥ 30 min, with the LPS ≥ 15 min for any night; 2) And/or the mean WASO of 2 nights is ≥ 30 min, with neither night ≥20 min; 3) The mean SE of 2 nights is ≤ 85%, with the SE ≤ 87.5% for both nights. 4. During the study, the patient agreed to follow the daily bedtime between 9 and 12 pm , stayed in bed for 6.5-9 hours every night, and agreed to refrain from taking a nap.
  • 5. Female subjects are confirmed to be non-pregnant at screening; both men of reproductive potential and women of childbearing potential should agree to use medically acceptable and effective contraception throughout the study and within 1 month after the end of the study.
  • 6. Understand the study procedures and contents, voluntarily participate in the clinical study and sign the written Informed Consent Form (ICF), have good compliance during participation in the study, and are willing to attend the visits

Who cannot join

  • Sleep disorders associated with neurological disorders such as depression, anxiety, sleep disorders due to dementia; depression: Hamilton Depression Scale (HAMD) score ≥ 18 or item 3 (suicidal ideation) score of 3 or more; anxiety: Hamilton Anxiety Scale (HAMA) score ≥ 14; dementia: MMSE scale score ≤ 20 for primary school, ≤ 22 for secondary school (including technical secondary school), and ≤ 23 for college (including junior college).
  • Apnea-hypopnea index [AHI] and/or periodic limb movement index [PLMI] > 10 times/hour detected by PSG monitoring during the run-in period.
  • Patients with severe endocrine diseases, blood diseases, cardiovascular and cerebrovascular diseases, autoimmune diseases, respiratory function impairment and other related diseases.
  • Previous history of nervous system disorders such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, cognitive disorder, narcolepsy, and restless leg syndrome.
  • Receiving any hypnotics, antidepressants, antipsychotics, anticholinergics, memory-enhancing drugs, antihistamines, CYP3A inducers, CYP3A inhibitors within 2 weeks prior to the start of the lead-in PSG.
  • History of drug taking or addiction, which is known through questioning.
Show all 18Show fewer
  • Have any lifestyle that interferes with the study process or may interfere with sleep: for example, there will be travels across zones within the next 2 weeks or during the study period, or there will be shift work (night and daytime shift).etc.
  • Special occupants who need to operate machinery during the test period, such as professional drivers, high-altitude operators, etc.
  • Subjects who were treated with any other approved or investigational insomnia medication prior to the study, including other orexin receptor inhibitors, or specific herbal preparations, traditional Chinese medicines, and still needed to continue in the study.
  • AST and ALT > 2 × the upper limit of normal (ULN), or Cr > 1.5 × ULN, or white blood cells < lower limit of normal.
  • Hyperthyroidism or hypothyroidism.
  • History of alcohol abuse (defined as regular daily alcohol consumption exceeding the following criteria: approximately 720 mL of beer, or 240 mL of wine, or 60 mL of liquor).
  • History of drug abuse , or positive urine drug screening (screening and/or baseline) for any indicator.
  • Regular daily consumption of excessive tea and coffee drinks.
  • Patients who have participated in other drug clinical trials within the past 3 months, or participated in other research trials during this trial.
  • Pregnant or lactating women.
  • History of allergy to the investigational product or its components.
  • Have other conditions that make the subject unsuitable for participation in the clinical study in the opinion of the investigator.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

China33 sites

  • Beijing HuiLongGuan Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • Xuanwu Hospital, Capital Medical University

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • The First Hospital of Jilin University

    Changchun

  • Hunan Brain Hospital

    Changsha

  • Xiangya Hospital, Central South University

    Changsha

  • West China Hospital, Sichuan University

    Chengdu

  • Army Specialty Medical Center

    Chongqing

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Nanfang Hospital of Southern Medical University (Department of Psychiatry)

    Guangzhou

  • Nanfang Hospital, Southern Medical University (Sleep Medicine Center)

    Guangzhou

  • The First Affiliated Hospital of Jinan University

    Guangzhou

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

  • The Affiliated Hospital of Jiujiang University

    Jiujiang

  • The First Affiliated Hospital of Kunming Medical University

    Kunming

  • The First People's Hospital of Yunnan Province

    Kunming

  • Jiangxi Provincial Psychiatric Hospital

    Nanchang

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing

    Nanjing

  • The First People 's Hospital of Nantong

    Nantong

  • Qingdao Municipal Hospital

    Qingdao

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou

  • Huashan Hospital Affiliated to Fudan University

    Shanghai

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

  • The First Hospital of Hebei Medical University

    Shijiazhuang

  • The Third Hospital of Hebei Medical University

    Shijiazhuang

  • The Second Affiliated Hospital of Soochow University

    Suzhou

  • Tianjin Anding Hospital

    Tianjin

  • Wuhan Mental Health Center

    Wuhan

  • Tangdu Hospital, Fourth Military Medical University, PLA

    Xi'an

  • The Second Affiliated Hospital of Xinxiang Medical University

    Xinxiang

  • Henan Provincial People's Hospital

    Zhengzhou

  • The Affiliated Hospital of Zunyi Medical College

    Zunyi

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Primary Chronic Insomnia Disorder

The main purpose of this study is to evaluate the efficacy and safety of YZJ-1139 in the short-term treatment of primary chronic insomnia, explore the optimal effective dose, and provide the basis for phase III clinical trials

Being tested
YZJ-1139 10mg, YZJ-1139 20mg, YZJ-1139 40mg, YZJ-1139 60mg, Placebo
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

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

  • YZJ-1139 10mgDrug

    YZJ-1139 10mg tablets

  • YZJ-1139 20mgDrug

    YZJ-1139 20mg tablets

  • YZJ-1139 40mgDrug

    YZJ-1139 40mg tablets

  • YZJ-1139 60mgDrug

    YZJ-1139 60mg tablets

  • PlaceboDrug

    Match placebo tablets

Study groups in NCT06680505
Study groupRoleWhat they receive
YZJ-1139 10mgExperimentalNot described
Receives: Drug: YZJ-1139 10mg
YZJ-1139 20mgExperimentalNot described
Receives: Drug: YZJ-1139 20mg
YZJ-1139 40mgExperimentalNot described
Receives: Drug: YZJ-1139 40mg
YZJ-1139 60mgExperimentalNot described
Receives: Drug: YZJ-1139 60mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Sleep efficiency (SE) monitored by PSG

    SE is the percentage of the subject 's total sleep time versus the monitored time；Changes from baseline (mean of any consecutive 2 days from Day -7 to Day -1) were evaluated separately for all subjects on Day 1 / Day 2, Day 13 / Day 14 of dosing, and for 1/5 subjects in each group on Day 27 / Day 28 of dosing.

    Measured: Baseline , for all subjects: Day 1 / Day 2,Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28

Secondary outcomes (6)

  1. Total sleep time (TST), sleep latency (LPS), sleep wake time (WASO), number of sleep awakenings (NAW) monitored by PSG

    Changes from baseline (mean of any consecutive 2 days from Day -7 to Da y -1) were evaluated separately for all subjects on Day 1 / Day 2, Day 13 / Day 14 of dosing, and for 1/5 subjects in each group on Day 27 / Day 28 of dosing.

    Measured: Baseline ; for all subjects: Day 1 / Day 2, Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28

  2. Evaluation of Sleep Structures Recorded by PSG Monitoring

    To evaluate changes from baseline on Day 1 and Day 14 of dosing in all subjects and Day 28 of dosing in 1/5 subjects in each group

    Measured: Baseline, for all subjects: Day 1, Day 14; for 1/5 subjects: Day 28

  3. Subjective Total Sleep Time (sTST), Subjective Sleep Latency (sTSO) Recorded by Sleep Diary

    The mean value at Week 1 and Week 2 for all subjects and the mean value at Week 4 for 1/5 subjects in each group were evaluated for the changes from the baseline value (mean value during the run-in period)

    Measured: Baseline, for all subjects: Week 1,Week 2, for 1/5 subjects:Week 4

  4. Total sleep time (TST), sleep latency (SL), sleep awakening time (WASO), number of sleep awakenings (NAW) and sleep efficiency (SE) recorded by body movement recorder

    According to the index values measured by body movement recorder, the mean value at Week 1, mean value at Week 2 and mean value at Week 4 of medication for 1/5 subjects in each group were taken from all subjects to evaluate the change values from the baseline values (mean value during run-in period), respectively

    Measured: Baseline, for all subjects:Week 1,Week 2, for 1/5 subjects:Week 4

  5. Insomnia Severity Index (ISI)

    Changes from baseline were evaluated separately for all subjects on Day 14 of dosing and for 1/5 subjects in each group on Day 28 of dosing

    Measured: Baseline, for all subjects: Day 14, for 1/5 subjects:Day 28

  6. Rebound evaluation and proportion of rebound patients

    All subjects should receive body movement recorder test and sleep diary during the follow-up period, and each indicator will be compared with the baseline period. If the baseline value is reached or worse than the baseline value, it is defined as rebound

    Measured: Follow-up Period, 7 days after double-blind treatment.

Timeline

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

  1. First posted8 Nov 2024
  2. Study start4 Aug 2019
  3. Primary completion30 Sep 2020
  4. Study completion29 Mar 2021

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06680505
Sponsor's protocol ID
YZJ-1139-2-01
Status last verified
Nov 2024
First submitted
1 Nov 2024
Last updated
8 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YZJ-1139 10mg, YZJ-1139 20mg and YZJ-1139 40mg in people with Insomnia Disorder, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 33 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 6 inclusion and 18 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Sleep efficiency (SE) monitored by PSG (time frame: Baseline , for all subjects: Day 1 / Day 2,Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28). 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 NCT06680505.

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 8 Nov 2024.

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