Stress Disorders, Post-TraumaticPhase 1/2NCT04071600
Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder
A Phase 1/2 study testing Neuropeptide Y in people with Stress Disorders, Post-Traumatic and Stress Disorders, Traumatic, Acute, run by New York Medical College at 2 sites in United States.
Trial summary
Level 2 trauma patients admitted to Westchester Medical Center who consent and meet the inclusion criteria will answer a questionnaire, be tested on Beck Anxiety Index, assessed for vital signs and provide blood and urine samples for biomarker testing. before the intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Acute
- What is being tested?
- Neuropeptide Y
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2019to 1 Nov 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Level 2 trauma patients admitted to the trauma floors or trauma ICU at Westchester Medical Center
- Experienced fear at the time of the trauma
Who cannot join
- Vulnerable populations, such as pregnant women, prisoners, persons with decisional incapacity.
- History of coronary artery disease, heart failure, prior stroke, heart surgery
- Bood pressure >160/90
- Acutely psychotic
- Current diagnosis of anorexia nervosa, bulimia
- Current diagnosis of cancer
Show all 10Show fewer
- Drug abuse or dependence in the preceding 3 months,
- Any unstable medical condition
- Active suicidal/homicidal ideation
- Cannot speak, read, write and understand English at least at 8th grade level.
Trial locations and contacts
2 sites in 1 country.
Yvette Smolin, MD contact
United States2 sites
New York Medical College
Valhalla, New York, 10595
Esther L Sabban, PhD
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder (ASD)
Level 2 trauma patients admitted to Westchester Medical Center who consent and meet the inclusion criteria will answer a questionnaire, be tested on Beck Anxiety Index, assessed for vital signs and provide blood and urine samples for biomarker testing. before the intervention.
Part 1 Dose Escalation: Subjects will receive a single infusion NPY or vehicle delivered to the upper nasal cavity with an intranasal device. The administration of intranasal NPY will follow the 3 plus 3 model and Fibonacci dose escalation scheme.
Read more
Subjects will be assessed for Acute Stress Disorder (ASD) on the National Stressful Events Survey Acute Stress Disorder Sheet (NSESSS) at 3-7 and at 14-30 days post trauma, At >60 days post trauma to be evaluated with the PTSD Symptom Scale Interview for DSM-5 (PSS-I-5) and given the Beck Anxiety Inventory test.
Part 2 Dose Expansion Cohort: Once the maximal tolerated dose (MTD) is determined, we will follow it by a dose expansion cohort to obtain preliminary evidence of efficacy of intranasal NPY to alter the severity of ASD and inhibit the progression to PTSD and the usefulness of several biomarkers.
Read the detailed description
Patients admitted to the Westchester Medical Center as a level 2 trauma patient who meet the admission criteria will be asked to join the study and written consent will be obtained. Every patient who consents to participate will fill out a questionnaire of general information including education level, marital status, social support etc. and administered the Beck Anxiety Inventory. They will be asked to collect urine samples until the next morning.
The next morning at about 9-11 AM vital signs will be measured, including standing systolic blood pressure. Blood and the overnight urine samples will be collected for biomarker testing. This will include urinary norepinephrine levels, plasma ACTH and epigenetic changes in the genes for glucocorticoid receptor and norepinephrine transporter.
Subjects will then receive intranasal NPY (GMP-grade) delivered to the upper nasal cavity with an intranasal device from Kurve. We have chosen this device since it appears to be the best delivery system to the upper olfactory region of the nose for delivery to the brain. It has been used most widely, including the earlier clinical trial with intranasal NPY. After the intranasal NPY, patients will be evaluated for potential adverse reactions and vital signs measured at 30 min, 90 min, and every 4 hrs until released from the hospital. 1 and 3 days after the intranasal infusion.
The dose escalation of intranasal NPY will follow the 3 plus 3 model and Fibonacci dose escalation scheme with a starting dose of 9.6mg, selected based on the highest previously studied dose (Sayed et al. 2018). According to this model if no participant has a dose limiting toxicity (DLT), we will proceed to the next dose. If 1/3 has a DLT, 3 additional participants will be enrolled and if more than 1/6 have a DLT the dose escalation will be terminated.
A DLT will be defined as an adverse event or a clinically significant change in vital signs as follows: (1) any serious adverse event experienced at any time during the study that was determined to be at least "possibly" related to the study drug, or (2) a non-serious adverse event rated at least moderate in severity and at least "possibly" related to the study drug, or (3) occurrence of any of the following changes in vital signs with 90 minutes following administration of the NPY: (i) symptomatic hypotension or >20% decrease in systolic blood pressure (SBP) and an absolute SBP < 90; (ii) symptomatic hypertension or >20% increase in SBP and an absolute SBP >170 or diastolic blood pressure (DBP) > 95; (iii) new onset of tachyarrhythmia (defined as a heart rate >100 bpm) or symptomatic bradycardia (heart rate <60 bpm).
Tests for Persistent ASD and Development of PTSD At 3-7 and 14-30 days post trauma, subjects will be asked to fill out the National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS). After at least 60 days from the trauma they will be given an interview to be evaluated with the PTSD Symptom Scale Interview for DSM-5 (PSS-I-5) as well as the Beck Anxiety Inventory.
Dose escalation cohort After reaching the maximal tolerated dose (MTD) of intranasal NPY or four dose escalation steps without reaching a DLT, we will add a dose escalation cohort. The individuals in this cohort will be randomly assigned to be administered intranasal NPY or vehicle (placebo).
Based on the statistical analysis, we hope to be able to expand to 25-33 individuals per group in order to detect a 15% reduction in incidence of PTSD beyond the influence of the placebo with power of 80%.
Subjects will be tested for: Persistent ASD (NSESS) at days 3-7 and 14-30 after the trauma, PTSD and t 3-7 and 14-30 days post trauma: development of PTSD ( PSS-I-5), > 60 days post trauma); and anxiety (Beck Anxiety Inventory) and compared to groups given no intervention.
The information is expected provide preliminary data on efficacy of intranasal NPY administration to reduce the severity of ASD and attenuate the progression to PTSD. In addition, the results should provide preliminary information on usefulness of several biomarkers to inform on the progression of ASD and PTSD in level 2 trauma patients and on the response to intranasal NPY.
- Being tested
- Neuropeptide Y, Placebo
- Keywords
- neuropeptide Y, intranasal, biomarkers, anxiety
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Acute, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropeptide YDrug
Intranasal
PlaceboOther
Also called vehicle
intranasal
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Type two trauma patients randomly assigned to be administered the vehicle (water) with Kurve intranasal device once and followed for up to 60 days afterwards for development of Acute Stress Disorder and Posttraumatic Stress Disorder. Receives: Other: Placebo |
| Neuropeptide Y | Active comparator | The individuals in this arm will be randomly assigned to be administered intranasal NPY with Kurve intranasal device once and will be followed for at least 60 days afterwards for development of Acute Stress Disorder and Posttraumatic Stress Disorder. Receives: Drug: Neuropeptide Y |
| Control | No intervention | The individuals in this arm will be randomly assigned and treated the same as the other arms but with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Dose escalation until treatment emergent adverse effect
Measured: 6-9 months
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for PTSD
Rating for likely PTSD on PSS-I-5 a 20 item interview >60 days after the trauma
Measured: 2-3 years
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for early Acute Stress Disorder (ASD)
Rating on National Stressful Events Survey Acute Stress Disorder Short Form (NSESS) 3-7 days after traum
Measured: 2-3 years
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for prolonged Acute Stress Disorder (ASD)
Rating on National Stressful Events Survey Acute Stress Disorder Short Form (NSESS) 14-30 days after trauma
Measured: 2-3 years
Secondary outcomes (5)
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for anxiety
Scores on Beck Anxiety Inventory (BAI)
Measured: 2-3 years
Preliminary indication of usefulness of blood pressure to predict development of ASD and PTSD and response to intranasal NPY
Blood pressure measured sitting and standing
Measured: 3 years
Preliminary indication of usefulness of urinary norepinephrine to predict development of ASD and PTSD and usefulness of intranasal NPY
Urinary norepinephrine levels by ELISA
Measured: 3 years
Preliminary indication of usefulness of plasma ACTH to predict development of ASD and PTSD and response to intranasal NPY
Plasma ACTH by ELISA
Measured: 3 years
Preliminary indication of usefulness of epigentic changes in GR and NET genes to predict development of ASD and PTSD and response to intranasal NPY
Methylation of the genes for glucocorticoid receptor (GR) and Norepinephrine Transporter (NET)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Nov 2019 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Westchester Medical Center, U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Esther Sabban, New York Medical College
- Investigators
- Esther Sabban, PhD, Principal investigator, New York Medical CollegeRhea Dornbush, PhD, Principal investigator, New York Medical CollegeYvette Smolin, MD, Principal investigator, Westchestr Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071600
- Sponsor's protocol ID
- 13038
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sayed S, Van Dam NT, Horn SR, Kautz MM, Parides M, Costi S, Collins KA, Iacoviello B, Iosifescu DV, Mathe AA, Southwick SM, Feder A, Charney DS, Murrough JW. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. Int J Neuropsychopharmacol. 2018 Jan 1;21(1):3-11. doi: 10.1093/ijnp/pyx109.
PubMed 29186416Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
PubMed 35141873
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder (ASD)
- ClinicalTrials.gov ID
- NCT04071600
- Acronym / sponsor ID
- 13038
- Keywords
- neuropeptide Y, intranasal, biomarkers, anxiety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- Westchester Medical Center, U.S. Army Medical Research and Development Command
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 28 Aug 2019 (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.
Level 2 trauma patients admitted to Westchester Medical Center who consent and meet the inclusion criteria will answer a questionnaire, be tested on Beck Anxiety Index, assessed for vital signs and provide blood and urine samples for biomarker testing. before the intervention.
Part 1 Dose Escalation: Subjects will receive a single infusion NPY or vehicle delivered to the upper nasal cavity with an intranasal device. The administration of intranasal NPY will follow the 3 plus 3 model and Fibonacci dose escalation scheme.
Subjects will be assessed for Acute Stress Disorder (ASD) on the National Stressful Events Survey Acute Stress Disorder Sheet (NSESSS) at 3-7 and at 14-30 days post trauma, At >60 days post trauma to be evaluated with the PTSD Symptom Scale Interview for DSM-5 (PSS-I-5) and given the Beck Anxiety Inventory test.
Part 2 Dose Expansion Cohort: Once the maximal tolerated dose (MTD) is determined, we will follow it by a dose expansion cohort to obtain preliminary evidence of efficacy of intranasal NPY to alter the severity of ASD and inhibit the progression to PTSD and the usefulness of several biomarkers.
Detailed description
Patients admitted to the Westchester Medical Center as a level 2 trauma patient who meet the admission criteria will be asked to join the study and written consent will be obtained. Every patient who consents to participate will fill out a questionnaire of general information including education level, marital status, social support etc. and administered the Beck Anxiety Inventory. They will be asked to collect urine samples until the next morning.
The next morning at about 9-11 AM vital signs will be measured, including standing systolic blood pressure. Blood and the overnight urine samples will be collected for biomarker testing. This will include urinary norepinephrine levels, plasma ACTH and epigenetic changes in the genes for glucocorticoid receptor and norepinephrine transporter.
Subjects will then receive intranasal NPY (GMP-grade) delivered to the upper nasal cavity with an intranasal device from Kurve. We have chosen this device since it appears to be the best delivery system to the upper olfactory region of the nose for delivery to the brain. It has been used most widely, including the earlier clinical trial with intranasal NPY. After the intranasal NPY, patients will be evaluated for potential adverse reactions and vital signs measured at 30 min, 90 min, and every 4 hrs until released from the hospital. 1 and 3 days after the intranasal infusion.
The dose escalation of intranasal NPY will follow the 3 plus 3 model and Fibonacci dose escalation scheme with a starting dose of 9.6mg, selected based on the highest previously studied dose (Sayed et al. 2018). According to this model if no participant has a dose limiting toxicity (DLT), we will proceed to the next dose. If 1/3 has a DLT, 3 additional participants will be enrolled and if more than 1/6 have a DLT the dose escalation will be terminated.
A DLT will be defined as an adverse event or a clinically significant change in vital signs as follows: (1) any serious adverse event experienced at any time during the study that was determined to be at least "possibly" related to the study drug, or (2) a non-serious adverse event rated at least moderate in severity and at least "possibly" related to the study drug, or (3) occurrence of any of the following changes in vital signs with 90 minutes following administration of the NPY: (i) symptomatic hypotension or >20% decrease in systolic blood pressure (SBP) and an absolute SBP < 90; (ii) symptomatic hypertension or >20% increase in SBP and an absolute SBP >170 or diastolic blood pressure (DBP) > 95; (iii) new onset of tachyarrhythmia (defined as a heart rate >100 bpm) or symptomatic bradycardia (heart rate <60 bpm).
Tests for Persistent ASD and Development of PTSD At 3-7 and 14-30 days post trauma, subjects will be asked to fill out the National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS). After at least 60 days from the trauma they will be given an interview to be evaluated with the PTSD Symptom Scale Interview for DSM-5 (PSS-I-5) as well as the Beck Anxiety Inventory.
Dose escalation cohort After reaching the maximal tolerated dose (MTD) of intranasal NPY or four dose escalation steps without reaching a DLT, we will add a dose escalation cohort. The individuals in this cohort will be randomly assigned to be administered intranasal NPY or vehicle (placebo).
Based on the statistical analysis, we hope to be able to expand to 25-33 individuals per group in order to detect a 15% reduction in incidence of PTSD beyond the influence of the placebo with power of 80%.
Subjects will be tested for: Persistent ASD (NSESS) at days 3-7 and 14-30 after the trauma, PTSD and t 3-7 and 14-30 days post trauma: development of PTSD ( PSS-I-5), > 60 days post trauma); and anxiety (Beck Anxiety Inventory) and compared to groups given no intervention.
The information is expected provide preliminary data on efficacy of intranasal NPY administration to reduce the severity of ASD and attenuate the progression to PTSD. In addition, the results should provide preliminary information on usefulness of several biomarkers to inform on the progression of ASD and PTSD in level 2 trauma patients and on the response to intranasal NPY.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboType two trauma patients randomly assigned to be administered the vehicle (water) with Kurve intranasal device once and followed for up to 60 days afterwards for development of Acute Stress Disorder and Posttraumatic Stress Disorder. |
| Neuropeptide Y | Active comparator | Drug: Neuropeptide YThe individuals in this arm will be randomly assigned to be administered intranasal NPY with Kurve intranasal device once and will be followed for at least 60 days afterwards for development of Acute Stress Disorder and Posttraumatic Stress Disorder. |
| Control | No intervention | –The individuals in this arm will be randomly assigned and treated the same as the other arms but with no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Level 2 trauma patients admitted to the trauma floors or trauma ICU at Westchester Medical Center
- Experienced fear at the time of the trauma
Key exclusion criteria (10 listed)
- Vulnerable populations, such as pregnant women, prisoners, persons with decisional incapacity.
- History of coronary artery disease, heart failure, prior stroke, heart surgery
- Bood pressure >160/90
- Acutely psychotic
- Current diagnosis of anorexia nervosa, bulimia
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 |
|---|---|---|
| Neuropeptide YIntranasal | Drug | Neuropeptide Y |
| PlaceboAlso: vehicleintranasal | Other | Placebo |
Primary outcome
Safety and Tolerability
Time frame: 6-9 months
Dose escalation until treatment emergent adverse effect
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for PTSD
Time frame: 2-3 years
Rating for likely PTSD on PSS-I-5 a 20 item interview >60 days after the trauma
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for early Acute Stress Disorder (ASD)
Time frame: 2-3 years
Rating on National Stressful Events Survey Acute Stress Disorder Short Form (NSESS) 3-7 days after traum
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for prolonged Acute Stress Disorder (ASD)
Time frame: 2-3 years
Rating on National Stressful Events Survey Acute Stress Disorder Short Form (NSESS) 14-30 days after trauma
5 secondary outcomes
Preliminary indication of efficacy of intranasal NPY compared to placebo and no intervention for anxiety
Time frame: 2-3 years
Preliminary indication of usefulness of blood pressure to predict development of ASD and PTSD and response to intranasal NPY
Time frame: 3 years
Preliminary indication of usefulness of urinary norepinephrine to predict development of ASD and PTSD and usefulness of intranasal NPY
Time frame: 3 years
Preliminary indication of usefulness of plasma ACTH to predict development of ASD and PTSD and response to intranasal NPY
Time frame: 3 years
Preliminary indication of usefulness of epigentic changes in GR and NET genes to predict development of ASD and PTSD and response to intranasal NPY
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 29186416Sayed S, Van Dam NT, Horn SR, Kautz MM, Parides M, Costi S, Collins KA, Iacoviello B, Iosifescu DV, Mathe AA, Southwick SM, Feder A, Charney DS, Murrough JW. A Randomized Dose-Ranging Study of Neuropeptide Y in Patients with Posttraumatic Stress Disorder. Int J Neuropsychopharmacol. 2018 Jan 1;21(1):3-11. doi: 10.1093/ijnp/pyx109.
- Derived from this study: PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
- Derived from this study: PubMed 35141873Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
- Individual participant dataSharing planned: No
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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.
Yvette Smolin, MD contact
Esther Sabban, PhD principal investigator
New York Medical College
Rhea Dornbush, PhD principal investigator
New York Medical College
Yvette Smolin, MD principal investigator
Westchestr Medical Center
2 sites 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 Neuropeptide Y in people with Stress Disorders, Post-Traumatic and Stress Disorders, Traumatic, Acute, run by New York Medical College at 2 sites in United States.
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 2 inclusion and 10 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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?
Contact Esther L Sabban, PhD (9145944068, sabban@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 6-9 months). The study lists 4 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 NCT04071600, which also lists 3 linked publications.
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 28 Aug 2019.