Insomnia DisorderPhase 1/2NCT06279286
Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder
A Phase 1/2 study testing HS-10506 in people with Insomnia Disorder, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- HS-10506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- May 2024to Jan 2025
- Phase
- Phase 1/2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be 18 to 64 years of age, inclusive
- Subjects are required to voluntarily sign the informed consent form;
- Body mass index (BMI): for phase Ib, males must weigh at least 50 kilogram (kg), females at least 45 kg, and BMI (weight/height2 [kg/m2]) must be in the range of 18 to 30 kg/m2 (inclusive) for both gender; for phase II, BMI must be in the range of 18 to 35 kg/m2 (inclusive);
- Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
- Participants must have Insomnia Severity Index (ISI) scores >=15 at screening and baseline;
- Subjective sleep assessment: for phase Ib, subjects must have a self-reported sleep latency (sSOL) >= 30 minutes, a subjective sleep awakening time (sWASO) >= 30 minutes, and a subjective total sleep time (sTST) =< 6.5 hours using the sleep diary for at least three nights every week in the last 1 month prior to screening; For phase II, subjects must have an sSOL >= 30 minutes, sWASO >= 30 minutes, and sTST =< 6.5 hours for at least three nights every week within one month prior to screening; and sSOL >= 30 minutes, sWASO >= 30 minutes, and sTST =< 6.5 hours for at least 3 nights from sleep diary in the last 7 days;
- PSG: for phase Ib, participants must demonstrate an LPS >= 20 minutes, TST < 420 minutes, and WASO >= 30 minutes at screening; for phase II, participants must demonstrate a 2-night mean LPS >= 30 minutes with neither night < 20 minutes, a 2-night mean TST =< 6.5 hours with neither night > 7 hours and a 2-night mean WASO >= 30 minutes with neither nigh < 20 minutes.
Who cannot join
- Has history of or current sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;
- Has a hypopnea index (AHI) >10 times/hour or periodic leg movement index (PLMI) >10 times/hour monitored by PSG at screening or run-in period;
- Has history of or current neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or clinically significant and/or unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;
- (For phase II only) Has a Hamilton Anxiety Scale (HAMA) score >= 14 or Hamilton Depression Scale (HAMD-17) score >= 18;
- Use of any medication that may affect the pharmacokinetics of HS-10506 within the past 2 weeks or 5 half-lives of the medication;
- Use of any medication that may affect sleep-wake function, or any other prohibited central nervous system active medications within 1 week or 5 half-lives of the medication;
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- Has received systemic hypnotherapy, cognitive behavioral therapy (CBT), or other non-pharmacological treatments for insomnia in last 4 weeks or have plans during the study;
- Working across 3 or more time zones or shift work within 2 weeks prior to screening;
- Regularly naps more than 3 naps per week for > 1 hour each time within the past 2 weeks prior to screening;
- Has a risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS), or has a high risk of suicide at the discretion of the investigator;
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital Capital Medical University
Beijing
yuping Wang, PhD, wangyuping01@sina.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ⅰb/Ⅱ Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10506 in Chinese Adult Participants With Insomnia Disorder
The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.
Read the detailed description
This study consists of two stages: phase Ib and phase II. Primary objective of phase Ib Study is to assess the safety, tolerability of HS-10506 in subjects with insomnia disorder. .
Primary objective of phase II Study is to assess the efficacy of HS-10506 in subjects with insomnia disorder.
- Conditions
- Insomnia Disorder
- Being tested
- HS-10506, Placebo
- Keywords
- Clinical trial, insomnia disorder, phase Ⅰb/Ⅱ
- 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.
HS-10506Drug
HS-10506, tablets (10mg, 20mg, 40mg and 80mg) at night once daily from Day 1 to Day 5 in phase Ib study, and from Day 1 to Day 28 in phase II study.
PlaceboDrug
Placebo, placebo tablets matching the HS-10506 tablets
| Study group | Role | What they receive |
|---|---|---|
| HS-10506, 10 milligram (mg) and placebo | Experimental | Phase Ib part: Participants will receive either 10mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 10mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. Receives: Drug: HS-10506; Drug: Placebo |
| HS-10506, 20 milligram (mg) and placebo | Experimental | Phase Ib part: Participants will receive either 20mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 20mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. Receives: Drug: HS-10506; Drug: Placebo |
| HS-10506, 40 milligram (mg) and placebo | Experimental | Phase Ib part: Participants will receive either 40mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 40mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. Receives: Drug: HS-10506; Drug: Placebo |
| HS-10506, 80 milligram (mg) and placebo | Experimental | Phase Ib part: Participants will receive either 80mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 80mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. Receives: Drug: HS-10506; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AE)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Baseline up to the end of the study (3 days after the last dose) or early withdrawal
Incidence and severity of serious adverse events (SAE)
An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Baseline up to the end of the study (3 days after the last dose) or early withdrawal
Changes in laboratory test before and after drug administration
Number of participants with clinically significant laboratory abnormalities, including complete blood cell count, urinalysis, serum chemistry, coagulation function were reported.
Measured: Baseline up to the end of the study (3 days after last dose) or early withdrawal
Changes in ECG before and after drug administration
Number of participants with clinically significant ECG abnormalities were reported.
Measured: Baseline up to the end of the study (3 days after last dose) or early withdrawal
Changes in Karolinska Sleepiness Scale (KSS) scores before and after drug administration
The KSS is a patient-reported assessment of drowsiness level at the time of scale administration.
Measured: From start of the drug administration to the next day of the last dose or early withdrawal
Change from baseline in the mean LPS measured by PSG on Night 13 and Night 14
LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep.
Measured: Baseline, Night 13& Night 14
Secondary outcomes (13)
The maximum plasma concentration (C[max])
The C[max] is the maximum observed plasma concentration and will be determined for HS-10506.
Measured: Baseline up to 48 hours after the last dose or early withdrawal
Time to reach the maximum plasma concentration (T[max])
Time to reach maximum observed plasma concentration (T[max]) of HS-10506.
Measured: Baseline up to 48 hours after the last dose or early withdrawal
Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t])
Area under the concentration-time curve from time zero to last time of quantifiable concentration of HS-10506.
Measured: Baseline up to 48 hours after the last dose or early withdrawal
Terminal elimination half-life (t1/2)
Apparent terminal elimination half-life of HS-10506.
Measured: Baseline up to 48 hours after the last dose or early withdrawal
Change in latency to persistent sleep (LPS) relative to baseline on night 5 of PSG monitoring
Latency to persistent sleep (LPS) is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep over PSG assessment.
Measured: Baseline and Night 5
Change in Wake After Sleep Onset (WASO) relative to baseline on night 5 of PSG monitoring
Wake After Sleep Onset (WASO) is defined as the duration of wakefulness from the onset of persistent sleep over the PSG assessment.
Measured: Baseline and Night 5
Change from baseline in mean LPS measured by PSG
Latency to Persistent Sleep (LPS) is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep over PSG assessment.
Measured: Baseline up to 28 days.
Change from baseline in mean TST measured by PSG
Total sleep time (TST) is the total amount of sleep time scored during the total recording time over PSG assessment.
Measured: Baseline up to 28 days.
Change from baseline in mean WASO measured by PSG
Wake after initial sleep onset (WASO) is defined as the duration of wakefulness from the onset of persistent sleep over PSG assessment.
Measured: Baseline up to 28 days.
Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) recorded in the sleep diary
Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) measured by sleep diary.
Measured: Baseline up to 28 days.
Change from baseline in the mean values of self-reported total sleep time (sTST) recorded in the sleep diary
Change from baseline in mean self-reported total sleep time measured by sleep diary.
Measured: Baseline up to 28 days.
Incidence and severity of adverse events (AE)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Baseline up to 28 days.
Incidence and severity of serious adverse events (SAE)
An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Baseline up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startMay 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279286
- Sponsor's protocol ID
- HS-10506-201
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase Ⅰb/Ⅱ Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10506 in Chinese Adult Participants With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT06279286
- Acronym / sponsor ID
- HS-10506-201
- Conditions
- Insomnia Disorder
- Keywords
- Clinical trial, insomnia disorder, phase Ⅰb/Ⅱ
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.
Detailed description
This study consists of two stages: phase Ib and phase II. Primary objective of phase Ib Study is to assess the safety, tolerability of HS-10506 in subjects with insomnia disorder. .
Primary objective of phase II Study is to assess the efficacy of HS-10506 in subjects with insomnia disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-10506, 10 milligram (mg) and placebo | Experimental | Drug: HS-10506, Drug: PlaceboPhase Ib part: Participants will receive either 10mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 10mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. |
| HS-10506, 20 milligram (mg) and placebo | Experimental | Drug: HS-10506, Drug: PlaceboPhase Ib part: Participants will receive either 20mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 20mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. |
| HS-10506, 40 milligram (mg) and placebo | Experimental | Drug: HS-10506, Drug: PlaceboPhase Ib part: Participants will receive either 40mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 40mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. |
| HS-10506, 80 milligram (mg) and placebo | Experimental | Drug: HS-10506, Drug: PlaceboPhase Ib part: Participants will receive either 80mg of HS-10506 or matching placebo at night on Day 1 up to Day 5. Phase II part: Participants will receive either 80mg of HS-10506 or matching placebo at night on Day 1 up to Day 28. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must be 18 to 64 years of age, inclusive
- Subjects are required to voluntarily sign the informed consent form;
- Body mass index (BMI): for phase Ib, males must weigh at least 50 kilogram (kg), females at least 45 kg, and BMI (weight/height2 [kg/m2]) must be in the range of 18 to 30 kg/m2 (inclusive) for both gender; for phase II, BMI must be in the range of 18 to 35 kg/m2 (inclusive);
- Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
- Participants must have Insomnia Severity Index (ISI) scores >=15 at screening and baseline;
Key exclusion criteria (11 listed)
- Has history of or current sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;
- Has a hypopnea index (AHI) >10 times/hour or periodic leg movement index (PLMI) >10 times/hour monitored by PSG at screening or run-in period;
- Has history of or current neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or clinically significant and/or unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;
- (For phase II only) Has a Hamilton Anxiety Scale (HAMA) score >= 14 or Hamilton Depression Scale (HAMD-17) score >= 18;
- Use of any medication that may affect the pharmacokinetics of HS-10506 within the past 2 weeks or 5 half-lives of the medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10506HS-10506, tablets (10mg, 20mg, 40mg and 80mg) at night once daily from Day 1 to Day 5 in phase Ib study, and from Day 1 to Day 28 in phase II study. | Drug | HS-10506, 10 milligram (mg) and placebo, HS-10506, 20 milligram (mg) and placebo, HS-10506, 40 milligram (mg) and placebo, HS-10506, 80 milligram (mg) and placebo |
| PlaceboPlacebo, placebo tablets matching the HS-10506 tablets | Drug | HS-10506, 10 milligram (mg) and placebo, HS-10506, 20 milligram (mg) and placebo, HS-10506, 40 milligram (mg) and placebo, HS-10506, 80 milligram (mg) and placebo |
Primary outcome
Incidence and severity of adverse events (AE)
Time frame: Baseline up to the end of the study (3 days after the last dose) or early withdrawal
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Incidence and severity of serious adverse events (SAE)
Time frame: Baseline up to the end of the study (3 days after the last dose) or early withdrawal
An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Changes in laboratory test before and after drug administration
Time frame: Baseline up to the end of the study (3 days after last dose) or early withdrawal
Number of participants with clinically significant laboratory abnormalities, including complete blood cell count, urinalysis, serum chemistry, coagulation function were reported.
Changes in ECG before and after drug administration
Time frame: Baseline up to the end of the study (3 days after last dose) or early withdrawal
Number of participants with clinically significant ECG abnormalities were reported.
Changes in Karolinska Sleepiness Scale (KSS) scores before and after drug administration
Time frame: From start of the drug administration to the next day of the last dose or early withdrawal
The KSS is a patient-reported assessment of drowsiness level at the time of scale administration.
Change from baseline in the mean LPS measured by PSG on Night 13 and Night 14
Time frame: Baseline, Night 13& Night 14
LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep.
13 secondary outcomes
The maximum plasma concentration (C[max])
Time frame: Baseline up to 48 hours after the last dose or early withdrawal
Time to reach the maximum plasma concentration (T[max])
Time frame: Baseline up to 48 hours after the last dose or early withdrawal
Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t])
Time frame: Baseline up to 48 hours after the last dose or early withdrawal
Terminal elimination half-life (t1/2)
Time frame: Baseline up to 48 hours after the last dose or early withdrawal
Change in latency to persistent sleep (LPS) relative to baseline on night 5 of PSG monitoring
Time frame: Baseline and Night 5
Change in Wake After Sleep Onset (WASO) relative to baseline on night 5 of PSG monitoring
Time frame: Baseline and Night 5
Change from baseline in mean LPS measured by PSG
Time frame: Baseline up to 28 days.
Change from baseline in mean TST measured by PSG
Time frame: Baseline up to 28 days.
Change from baseline in mean WASO measured by PSG
Time frame: Baseline up to 28 days.
Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) recorded in the sleep diary
Time frame: Baseline up to 28 days.
Change from baseline in the mean values of self-reported total sleep time (sTST) recorded in the sleep diary
Time frame: Baseline up to 28 days.
Incidence and severity of adverse events (AE)
Time frame: Baseline up to 28 days.
Incidence and severity of serious adverse events (SAE)
Time frame: Baseline up to 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HS-10506 in people with Insomnia Disorder, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AE) (time frame: Baseline up to the end of the study (3 days after the last dose) or early withdrawal). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2024.