Parkinson DiseasePhase 2INI-PDNCT04251585
Intranasal Insulin in Parkinson's Disease
A Phase 2 study testing Regular Novolin R in people with Parkinson Disease, run by HealthPartners Institute at 1 site in United States.
Trial summary
This project will investigate exploratory outcomes related to the effect of intranasal insulin on cognition, mood, apathy and motor performance of subjects with Parkinson's disease over a 3 week period. Read more about this study
- Who is it for?
- Ages 41 to 89 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Regular Novolin R
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 27 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 41 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to Movement disorder society (MDS) clinical diagnostic criteria for Parkinson's disease confirmed by a fellowship trained movements disorder specialist
- Subject is Hoehn \& Yahr stage less than or equal to 3
- Subject has a MOCA score ≥10.
- Subject is > 40 and <90 years of age.
- Female subjects are post-menopausal or have a negative pregnancy test
- The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing of cognitive function, memory and physiology.
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- Subject has provided informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative.
- Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian agents and is willing to remain on this dose for the duration of the study. If the subject is on a cholinesterase inhibitor, a stable dose without changes for 1 month is also required.
- Subject has undergone a brain CT or MRI prior to the study as part of their previous diagnostic workup for PD to rule out underlying structural lesions, as determined clinically significant by the investigator
Who cannot join
- Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, neuroleptics), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
- Subject has medical history and/or clinically determined disorders: chronic sinusitis, untreated thyroid disease, or significant head trauma.
- Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, condition known to affect absorption, distribution, metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal disease or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator.
- Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
- Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
- Subject is currently taking sedative medications that are clinically contraindicated as determined by investigator.
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- Subject has undergone a recent change (<1 month) in their anti-parkinsonian medication, cholinesterase inhibitor or anti-depressant medication.
- Subject has current or recent drug or alcohol abuse or dependence as defined by Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV TR).
- Screening laboratory results that are medically relevant, in which inclusion would pose a safety risk to the subject as determined by investigator.
- Subject has participated in a clinical trial investigation within 3 months of this study.
- Subject has an insulin allergy.
- Subject has Insulin-dependent diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
About this study
Official title: Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease
This project will investigate exploratory outcomes related to the effect of intranasal insulin on cognition, mood, apathy and motor performance of subjects with Parkinson's disease over a 3 week period.
Read the detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's dementia and was originally described as a motor disease. The diagnosis of PD is still based on the core motor features of bradykinesia, resting tremor, and rigidity, primarily as a result of degeneration of nigrostriatal dopaminergic neurons. In addition to the classic motor symptoms, however, PD is increasingly recognized as a multisystem disorder. A variety of non-motor symptoms, including cognitive deficits and dementia, are commonly observed in patients with PD.
In this study, we aim to investigate which intranasal insulin dose out of three doses and placebo, administered at three different doses or placebo over a 21-day period, is the optimum dosage based on safety and tolerability in Parkinson's disease. A similar design was used in a trial investigating intranasal oxytocin in frontotemporal dementia. Dosing for the first two groups of this study is based on previously conducted intranasal insulin studies in Alzheimer's disease (AD) and mild cognitive impairment (MCI), using daily doses on 20 and 40 IU of intranasal insulin. Higher dose have been found to be safe in healthy adults. Prior studies performed have demonstrated favorable effects of this regimen in the MCI/AD population without peripheral hypoglycemia.
- Conditions
- Parkinson Disease
- Being tested
- Regular Novolin R, Placebo
- Keywords
- intranasal, insulin
- Medical subject headings
- Parkinson Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Novolin RDrug
Intranasal insulin
PlaceboDrug
Intranasal placebo (0.9% saline)
| Study group | Role | What they receive |
|---|---|---|
| Low Insulin | Experimental | Regular insulin (Novolin-R) 20 international units (10 units) in one nostril twice daily for 21 days, 100 µl volume. Receives: Drug: Regular Novolin R |
| Medium Insulin | Experimental | Regular insulin (Novolin-R) 40 international units (10 units) in each nostril twice daily for 21 days, 100 µl volume. Receives: Drug: Regular Novolin R |
| High Insulin | Experimental | Regular insulin (Novolin-R) 80 international units (10 units) in each nostril twice daily for 21 days, 200 µl volume. Receives: Drug: Regular Novolin R |
| Placebo | Placebo comparator | 0.9% sodium chloride in each nostril twice daily for 21 days, 100 µl volume. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measured by Count of Safety Events
Composite safety event - this is a count of either a reduction of fasting glucose to <70 mg/dL or an unintended reduction of weight >5%. A larger composite event count indicates a less safe treatment.
Measured: 3 weeks
Safety Measured by Fasting Glucose
Pre-post change in fasting glucose (mg/dL). A larger decrease in fasting glucose indicates a less safe treatment.
Measured: baseline and 3 weeks
Safety Measured by Body Weight
Pre-post change in body weight (lbs). An unintended decrease in body weight indicates a less safe treatment.
Measured: baseline and 3 weeks
Safety Measured by the Number of Serious Adverse Events (SAE) and Adverse Events (AE)
Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.
Measured: 3 weeks
Secondary outcomes (17)
Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)
Pre-post difference. Total sum of scores. Range: 0-30. Higher score indicates less memory loss
Measured: 5 weeks
Cognitive Function Measured by the Weschler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span
Pre-post difference. Scaled score. Range: 1-19. Forward and backward. Lower score indicates more impairment.
Measured: 3 weeks
Cognitive Function Measured by the Trailmaking Test Part A Time
Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired.
Measured: baseline and 3 weeks
Cognitive Function Measured by the Trailmaking Test Part B Time
Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired.
Measured: baseline and 3 weeks
Cognitive Function Measured by the Trailmaking Test Parts A & B Errors
Pre-post difference. Total number of errors. No range. More errors indicate more impairment.
Measured: 3 weeks
Cognitive Function Measured by the Judgement of Line Orientation
Judgement of Line Orientation is an assessment of visuospatial ability. A Z-score of 0 represents the population mean. Pre-post difference. A positive difference indicates an improvement.
Measured: baseline and 3 weeks
Cognitive Function Measured by the Logical Memory Scaled Scores
Pre-post difference. Scaled score. Range: 1-19. Logical memory immediate and delayed. Lower score indicates more impairment.
Measured: baseline and 3 weeks
Cognitive Function Measured by the Logical Memory, Recognition
Pre-post difference in median category from baseline to 3 weeks on the Logical memory, recognition subscale. Scoring of this and all outcomes were based on best practices conveyed by study neuropsychologist during study design, and scoring approaches were chosen completely a priori. The recognition outcome of the LM test is derived from a series of conversions, as follows. First, the raw "process" score is converted to cumulative percentage (0-100). Because the cumulative percentage distribution is known to be skewed, best practice is to report scores as the following ordinal categorizations of cumulative percentages: <1, 3-9, 10-16, 17-25, 26-50, 51-75, and >75. To analyze them using simple statistics, these ordinal categories are converted to integer values (1-7), and the change in median ordinal category is presented along with 95% confidence intervals, generated by the Wilcoxon signed rank test with continuity correction.
Measured: baseline and 3 weeks
Cognitive Function Measured by the Hopkins Verbal Learning Test - Revised (HVLT)
Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired.
Measured: baseline and 3 weeks
Cognitive Function Measured by the Visuospatial Memory Test - Revised (BVMT)
Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired.
Measured: 3 weeks
Cognitive Function Measured by the Stroop Color Word Test (CWT)
Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired.
Measured: baseline and 3 weeks
Cognitive Function Measured by Fluency
Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired.
Measured: baseline and 3 weeks
Mood Measured by the Beck Depression Inventory - Second Edition
Pre-post difference. Raw score. Range: 0-63. Higher score indicates more symptomatic.
Measured: baseline and 3 weeks
Apathy Measured by the Apathy Scale
Pre-post difference. Raw score. Range: 0-42. Higher score indicates more symptomatic.
Measured: baseline and 3 weeks
Mood Measured by the Columbia Suicide Severity Rating (C-SSRS)
Pre-post difference. Raw score. Range:1 or 0. 1 score - more symptomatic, 0 score - no symptoms.
Measured: baseline and 3 weeks
Motor Function as Measured by the United Parkinson's Disease Rating Scale (UPDRS-III)
Pre-post difference. Raw score. Range: 0-72. Higher score indicates more symptomatic.
Measured: baseline and 3 weeks
Cognitive Function Measured by Visuospatial Memory Test - Revised (BVMT Recognition)
Pre-post difference in median category from baseline to 3 weeks on the Brief Visual Spatial Memory Test - Revised recognition. Scoring of this and all outcomes were based on best practices conveyed by study neuropsychologist during study design, and scoring approaches were chosen completely a priori. The recognition outcome of the BVMT test is derived from a series of conversions, as follows. First, the raw score is converted to cumulative percentage (0-100). Because the cumulative percentage distribution is known to be skewed, best practice is to report scores as the following ordinal categorizations of cumulative percentages: <2, 2-5, 6-10, 11-16, >16. To analyze them using simple statistics, these ordinal categories are converted to integer values (1-5), and the change in median ordinal category is presented along with 95% confidence intervals, generated by the Wilcoxon signed rank test with continuity correction.
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start4 Feb 2020
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of 3 treatment groups or the placebo group. * 20 international units twice daily (n=7) * 40 international units twice daily (n=7) * 80 international units twice daily (n=9) * placebo (n=7)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia C Johnson, MD, Principal investigator, HealthPartners Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251585
- Sponsor's protocol ID
- A19-214
- Acronym
- INI-PD
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2020
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Johnson JC, Kashyap B, Gustafson SK, O'Brien M, Frey WH 2nd, Svitak AL, Hanson LR. Safety and tolerability of intranasal insulin in Parkinson's disease. Front Neurol. 2026 Sep 9;17:1875165. doi: 10.3389/fneur.2026.1875165. eCollection 2026.
PubMed 42780868
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04251585
- Acronym / sponsor ID
- INI-PD / A19-214
- Conditions
- Parkinson Disease
- Keywords
- intranasal, insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 11 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will investigate exploratory outcomes related to the effect of intranasal insulin on cognition, mood, apathy and motor performance of subjects with Parkinson's disease over a 3 week period.
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's dementia and was originally described as a motor disease. The diagnosis of PD is still based on the core motor features of bradykinesia, resting tremor, and rigidity, primarily as a result of degeneration of nigrostriatal dopaminergic neurons. In addition to the classic motor symptoms, however, PD is increasingly recognized as a multisystem disorder. A variety of non-motor symptoms, including cognitive deficits and dementia, are commonly observed in patients with PD.
In this study, we aim to investigate which intranasal insulin dose out of three doses and placebo, administered at three different doses or placebo over a 21-day period, is the optimum dosage based on safety and tolerability in Parkinson's disease. A similar design was used in a trial investigating intranasal oxytocin in frontotemporal dementia. Dosing for the first two groups of this study is based on previously conducted intranasal insulin studies in Alzheimer's disease (AD) and mild cognitive impairment (MCI), using daily doses on 20 and 40 IU of intranasal insulin. Higher dose have been found to be safe in healthy adults. Prior studies performed have demonstrated favorable effects of this regimen in the MCI/AD population without peripheral hypoglycemia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of 3 treatment groups or the placebo group. * 20 international units twice daily (n=7) * 40 international units twice daily (n=7) * 80 international units twice daily (n=9) * placebo (n=7)
| Arm | Type | Receives |
|---|---|---|
| Low Insulin | Experimental | Drug: Regular Novolin RRegular insulin (Novolin-R) 20 international units (10 units) in one nostril twice daily for 21 days, 100 µl volume. |
| Medium Insulin | Experimental | Drug: Regular Novolin RRegular insulin (Novolin-R) 40 international units (10 units) in each nostril twice daily for 21 days, 100 µl volume. |
| High Insulin | Experimental | Drug: Regular Novolin RRegular insulin (Novolin-R) 80 international units (10 units) in each nostril twice daily for 21 days, 200 µl volume. |
| Placebo | Placebo comparator | Drug: Placebo0.9% sodium chloride in each nostril twice daily for 21 days, 100 µl volume. |
Who may qualify
- Ages
- 41 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to Movement disorder society (MDS) clinical diagnostic criteria for Parkinson's disease confirmed by a fellowship trained movements disorder specialist
- Subject is Hoehn \& Yahr stage less than or equal to 3
- Subject has a MOCA score ≥10.
- Subject is > 40 and <90 years of age.
- Female subjects are post-menopausal or have a negative pregnancy test
Key exclusion criteria (12 listed)
- Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, neuroleptics), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
- Subject has medical history and/or clinically determined disorders: chronic sinusitis, untreated thyroid disease, or significant head trauma.
- Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, condition known to affect absorption, distribution, metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal disease or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator.
- Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
- Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
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 |
|---|---|---|
| Regular Novolin RIntranasal insulin | Drug | High Insulin, Low Insulin, Medium Insulin |
| PlaceboIntranasal placebo (0.9% saline) | Drug | Placebo |
Primary outcome
Safety Measured by Count of Safety Events
Time frame: 3 weeks
Composite safety event - this is a count of either a reduction of fasting glucose to <70 mg/dL or an unintended reduction of weight >5%. A larger composite event count indicates a less safe treatment.
Safety Measured by Fasting Glucose
Time frame: baseline and 3 weeks
Pre-post change in fasting glucose (mg/dL). A larger decrease in fasting glucose indicates a less safe treatment.
Safety Measured by Body Weight
Time frame: baseline and 3 weeks
Pre-post change in body weight (lbs). An unintended decrease in body weight indicates a less safe treatment.
Safety Measured by the Number of Serious Adverse Events (SAE) and Adverse Events (AE)
Time frame: 3 weeks
Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.
17 secondary outcomes
Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)
Time frame: 5 weeks
Cognitive Function Measured by the Weschler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span
Time frame: 3 weeks
Cognitive Function Measured by the Trailmaking Test Part A Time
Time frame: baseline and 3 weeks
Cognitive Function Measured by the Trailmaking Test Part B Time
Time frame: baseline and 3 weeks
Cognitive Function Measured by the Trailmaking Test Parts A & B Errors
Time frame: 3 weeks
Cognitive Function Measured by the Judgement of Line Orientation
Time frame: baseline and 3 weeks
Cognitive Function Measured by the Logical Memory Scaled Scores
Time frame: baseline and 3 weeks
Cognitive Function Measured by the Logical Memory, Recognition
Time frame: baseline and 3 weeks
Cognitive Function Measured by the Hopkins Verbal Learning Test - Revised (HVLT)
Time frame: baseline and 3 weeks
Cognitive Function Measured by the Visuospatial Memory Test - Revised (BVMT)
Time frame: 3 weeks
Cognitive Function Measured by the Stroop Color Word Test (CWT)
Time frame: baseline and 3 weeks
Cognitive Function Measured by Fluency
Time frame: baseline and 3 weeks
Mood Measured by the Beck Depression Inventory - Second Edition
Time frame: baseline and 3 weeks
Apathy Measured by the Apathy Scale
Time frame: baseline and 3 weeks
Mood Measured by the Columbia Suicide Severity Rating (C-SSRS)
Time frame: baseline and 3 weeks
Motor Function as Measured by the United Parkinson's Disease Rating Scale (UPDRS-III)
Time frame: baseline and 3 weeks
Cognitive Function Measured by Visuospatial Memory Test - Revised (BVMT Recognition)
Time frame: baseline and 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42780868Johnson JC, Kashyap B, Gustafson SK, O'Brien M, Frey WH 2nd, Svitak AL, Hanson LR. Safety and tolerability of intranasal insulin in Parkinson's disease. Front Neurol. 2026 Sep 9;17:1875165. doi: 10.3389/fneur.2026.1875165. eCollection 2026.
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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.
Julia C Johnson, MD principal investigator
HealthPartners Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regular Novolin R in people with Parkinson Disease, run by HealthPartners Institute at 1 site 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 9 inclusion and 12 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 11 Feb 2026. 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 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 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?
Yes. Results are posted in the registry (first posted 11 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Measured by Count of Safety Events (time frame: 3 weeks). 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 NCT04251585, 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 11 Feb 2026.