Alzheimer DiseasePhase 2NCT04052737
PMZ-1620 (Sovateltide) in Mild to Moderate Alzheimer's Disease
A Phase 2 study testing Normal Saline along with standard treatment and PMZ-1620 (sovateltide) along with standard treatment in people with Alzheimer Disease and Dementia, run by Pharmazz, Inc. at 5 sites in India.
Trial summary
This is a prospective, multicentric, randomized, double blind, placebo controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 therapy along with standard supportive care in subjects with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Normal Saline along with standard treatment and PMZ-1620 (sovateltide) along with standard treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesIndia
- Study dates
- 23 Mar 2018to 6 Jan 2023
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females Aged 45 years through 85 years (have not had their 86th birthday)
- Men and women with a diagnosis of Alzheimer's disease according to the clinical criteria
- Women must be of non-childbearing potential, surgically sterile, or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control
- Able to give consent for participation on their own or through their Legally Acceptable Representative
- MRI/CT scan assessment within six months before baseline, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions
- MMSE score in between 11 to 26 in case of mild to moderate stage of Alzheimer's disease
- 6. Absence of major depressive disease according to Geriatric Depression Scale (GDS) of < 5 7. Previous decline in cognition for more than six months as documented in subject's medical records 8. Subject, who are on stable treatment with any of AD drugs are also eligible to participate in this study 9. Formal education for eight or more years 10. Subjects living at home or nursing home setting, without continuous nursing care 11. General health status acceptable for participation in a 6-months clinical trial 12. A caregiver available and living in the same household or interacting with the subject a sufficient time each week and available if necessary to assure administration of drug 13. Subjects with any other chronic conditions are stable and undergoing appropriate treatment
Who cannot join
- Subjects who have a Mini Mental State Examination (MMSE) score of < 10
- Subjects who have serious or unstable medical conditions that would exclude completion of all procedures and data collection for the study, or would be likely to preclude participation in a drug development trial
- A current Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of active major depression, schizophrenia or bipolar disorder
- Other infectious, metabolic or systemic diseases affecting the central nervous system
- Subjects who have participated in a clinical trial investigating an anti-amyloid agent
- Subjects who are currently participating in a clinical trial with an investigational drug
Show all 15Show fewer
- Subjects who, in the opinion of the physician, are otherwise unsuitable for this study
- Clinically significant, advanced or unstable disease that may interfere with outcome measures, and which may bias the assessment of the clinical or mental status of the subject or put the subject at special risk
- History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma)
- Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening
- Clinical or laboratory findings consistent with:
- Other primary degenerative dementia,
- Other neurodegenerative condition
- Seizure disorder
- Subjects, who are already taking sedatives, antidepressants, antipsychotics and antihistaminic medications
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
King George's Medical University
Lucknow, 226003
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, 226014
Seth GSMC & KEM Hospital
Mumbai, 400012
All India Institute of Medical Sciences
New Delhi, 110029
About this study
Official title: A Prospective, Multicentric, Randomized, Double Blind, Placebo Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy Along With Standard Supportive Care in Subjects of Mild to Moderate Alzheimer's Disease
This is a prospective, multicentric, randomized, double blind, placebo controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 therapy along with standard supportive care in subjects with mild to moderate Alzheimer's disease.
Read the detailed description
Alzheimer's is not just a disease of old age, approximately 200,000 Americans under the age of 65 having younger-onset Alzheimer's disease (AD). In 2015, there were approximately 29.8 million people worldwide with AD. The person with Alzheimer's disease can live an average of eight years after their symptoms become noticeable to others, but survival range is 4 to 20 years, depending on the age and other health conditions (www.alz.org). The pathophysiology of AD is related to the injury and death of neurons, initiating in the hippocampus brain region that is involved with memory and learning, then atrophy affects the entire brain. The cause of Alzheimer's disease is still poorly understood and about 70% of the risk is associated with genetic. Other risk factors may also associate with this like history of head injuries, depression, or hypertension. Like all types of dementia, Alzheimer's is also caused by brain cell death. Although AD is classified as a neurodegenerative dementia, considerable evidence links vascular dysfunction and vascular risk factors as pathogenesis of AD. However, it is a progressive brain cell death that happens over a course of time and treatments can't stop Alzheimer's from progressing, they can temporarily slow the worsening of dementia symptoms and improve quality of life for those with Alzheimer's and their caregivers (www.alz.org; www.who.int).
Sovateltide is an endothelin B (ETB) receptor agonist (previously used names IRL-1620, SPI-1620 and PMZ-1620; International Non-proprietary Name (INN) approved by WHO is sovateltide). Activation of ETB receptors with PMZ-1620 produces neurovascular repair and remodeling or neuroregeneration. There are hidden stem cells in the brain, which becomes active following injury to the brain. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the brain to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic activity and also increases cerebral blood flow.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Normal Saline along with standard treatment, PMZ-1620 (sovateltide) along with standard treatment
- Keywords
- Endothelin, Neurogenesis, Neural progenitor cells
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline along with standard treatmentDrug
Also called Vehicle
PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in Alzheimer's disease patients. In this arm normal saline along with standard treatment will be given for active comparison.
PMZ-1620 (sovateltide) along with standard treatmentDrug
Also called IRL-1620
PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in Alzheimer's disease patients.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Active comparator | Patients will receive the best available standard of care. In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, the same dosing regimen will be repeated every month for 6 months post randomization. Receives: Drug: Normal Saline along with standard treatment |
| PMZ-1620 (sovateltide) | Experimental | Patients will receive the best available standard of care. In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1 (total dose/day: 0.9 µg/kg body weight), the same dosing regimen will be repeated every month for 6 months post randomization. Receives: Drug: PMZ-1620 (sovateltide) along with standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PMZ-1620 related adverse events
The primary objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.
Measured: 160 days
Number of patients not receiving full treatment due to intolerance to PMZ-1620
Tolerability will be determined by the number of patients that do not receive all the 18 doses of PMZ-1620.
Measured: 160 days
Secondary outcomes (5)
Changes in clinical progression of AD as measured by Mini-Mental State Examination (MMSE)
Statistically relevant changes in clinical progression of AD as measured by MMSE after 3 and 6 months of treatment. Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
Measured: 160 days
Changes in neuropsychiatric inventory (NPI) Score
Statistically relevant changes in NPI Score after 3 and 6 months of treatment. The Neuropsychiatric Inventory (NPI) is designed to detect, quantify and track changes of psychiatric symptoms in a demented population. The NPI examines 12 sub-domains of behavioral functioning: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioral disturbances, and appetite and eating abnormalities. Maximum is 144 points, where less number of points is mild behavioral disturbance and more number of points is severe behavioral disturbance.
Measured: 160 days
Changes in Alzheimer's disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Statistically relevant changes in ADAS-Cog after 3 and 6 months of treatment. Alzheimer's disease Assessment Scale-Cognitive Subscale is a commonly used objective measure of cognitive change. It is designed to measure cognitive areas commonly seen to decline in AD patients.Total scores range from 0-70, with higher scores indicating greater cognitive impairment. Many regulatory authorities recognize a four-point change on the ADAS-Cog at 6 months as indicating a clinically important difference.
Measured: 160 days
Changes in hippocampal atrophy using MRI/CT
Changes in hippocampal atrophy using MRI/CT before and at the end of study
Measured: 160 days
Changes in electroencephalograms (EEGs)
Changes in electroencephalograms (EEGs) suggestive progression in AD symptom after 3 and 6 months of treatment. A decline of posterior slow-frequency alpha power which is peculiar feature of Alzheimer's disease and an amplitude increase of widespread delta and theta and an amplitude decrease of posterior alpha and/or beta sources that are reflective of Alzheimer's disease will be observed.
Measured: 160 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start23 Mar 2018
- Primary completion20 Dec 2022
- Study completion6 Jan 2023
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 Alzheimer 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour (total dose/day: 0.9 µg/kg body weight). The same dosing regimen will be repeated every month for 6 months post randomization. In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1 post randomization. The same dosing regimen will be repeated every month for 6 months post randomization. In both treatment groups, subjects will be provided the best available standard of care.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmazz, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anil Gulati, Study chair, Pharmazz, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052737
- Sponsor's protocol ID
- PMZ-1620/CLINICAL-2.2/2017
- Other IDs
- CTRI/2017/12/011003
- Status last verified
- Jan 2023
- First submitted
- 8 Aug 2019
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be communicated and published as manuscript
Publications
Gulati A, Hornick MG, Briyal S, Lavhale MS. A novel neuroregenerative approach using ET(B) receptor agonist, IRL-1620, to treat CNS disorders. Physiol Res. 2018 Jun 27;67(Suppl 1):S95-S113. doi: 10.33549/physiolres.933859.
PubMed 29947531Briyal S, Nguyen C, Leonard M, Gulati A. Stimulation of endothelin B receptors by IRL-1620 decreases the progression of Alzheimer's disease. Neuroscience. 2015 Aug 20;301:1-11. doi: 10.1016/j.neuroscience.2015.05.044. Epub 2015 May 27.
PubMed 26022359Briyal S, Shepard C, Gulati A. Endothelin receptor type B agonist, IRL-1620, prevents beta amyloid (Abeta) induced oxidative stress and cognitive impairment in normal and diabetic rats. Pharmacol Biochem Behav. 2014 May;120:65-72. doi: 10.1016/j.pbb.2014.02.008. Epub 2014 Feb 20.
PubMed 24561065
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Randomized, Double Blind, Placebo Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy Along With Standard Supportive Care in Subjects of Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04052737
- Acronym / sponsor ID
- PMZ-1620/CLINICAL-2.2/2017
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Endothelin, Neurogenesis, Neural progenitor cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pharmazz, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 12 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.
This is a prospective, multicentric, randomized, double blind, placebo controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 therapy along with standard supportive care in subjects with mild to moderate Alzheimer's disease.
Detailed description
Alzheimer's is not just a disease of old age, approximately 200,000 Americans under the age of 65 having younger-onset Alzheimer's disease (AD). In 2015, there were approximately 29.8 million people worldwide with AD. The person with Alzheimer's disease can live an average of eight years after their symptoms become noticeable to others, but survival range is 4 to 20 years, depending on the age and other health conditions (www.alz.org). The pathophysiology of AD is related to the injury and death of neurons, initiating in the hippocampus brain region that is involved with memory and learning, then atrophy affects the entire brain. The cause of Alzheimer's disease is still poorly understood and about 70% of the risk is associated with genetic. Other risk factors may also associate with this like history of head injuries, depression, or hypertension. Like all types of dementia, Alzheimer's is also caused by brain cell death. Although AD is classified as a neurodegenerative dementia, considerable evidence links vascular dysfunction and vascular risk factors as pathogenesis of AD. However, it is a progressive brain cell death that happens over a course of time and treatments can't stop Alzheimer's from progressing, they can temporarily slow the worsening of dementia symptoms and improve quality of life for those with Alzheimer's and their caregivers (www.alz.org; www.who.int).
Sovateltide is an endothelin B (ETB) receptor agonist (previously used names IRL-1620, SPI-1620 and PMZ-1620; International Non-proprietary Name (INN) approved by WHO is sovateltide). Activation of ETB receptors with PMZ-1620 produces neurovascular repair and remodeling or neuroregeneration. There are hidden stem cells in the brain, which becomes active following injury to the brain. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the brain to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic activity and also increases cerebral blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour (total dose/day: 0.9 µg/kg body weight). The same dosing regimen will be repeated every month for 6 months post randomization. In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1 post randomization. The same dosing regimen will be repeated every month for 6 months post randomization. In both treatment groups, subjects will be provided the best available standard of care.
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Active comparator | Drug: Normal Saline along with standard treatmentPatients will receive the best available standard of care. In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, the same dosing regimen will be repeated every month for 6 months post randomization. |
| PMZ-1620 (sovateltide) | Experimental | Drug: PMZ-1620 (sovateltide) along with standard treatmentPatients will receive the best available standard of care. In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1 (total dose/day: 0.9 µg/kg body weight), the same dosing regimen will be repeated every month for 6 months post randomization. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult males or females Aged 45 years through 85 years (have not had their 86th birthday)
- Men and women with a diagnosis of Alzheimer's disease according to the clinical criteria
- Women must be of non-childbearing potential, surgically sterile, or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control
- Able to give consent for participation on their own or through their Legally Acceptable Representative
- MRI/CT scan assessment within six months before baseline, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions
Key exclusion criteria (15 listed)
- Subjects who have a Mini Mental State Examination (MMSE) score of < 10
- Subjects who have serious or unstable medical conditions that would exclude completion of all procedures and data collection for the study, or would be likely to preclude participation in a drug development trial
- A current Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of active major depression, schizophrenia or bipolar disorder
- Other infectious, metabolic or systemic diseases affecting the central nervous system
- Subjects who have participated in a clinical trial investigating an anti-amyloid agent
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 |
|---|---|---|
| Normal Saline along with standard treatmentAlso: VehiclePMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in Alzheimer's disease patients. In this arm normal saline along with standard treatment will be given for active comparison. | Drug | Normal Saline |
| PMZ-1620 (sovateltide) along with standard treatmentAlso: IRL-1620PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in Alzheimer's disease patients. | Drug | PMZ-1620 (sovateltide) |
Primary outcome
Incidence of PMZ-1620 related adverse events
Time frame: 160 days
The primary objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.
Number of patients not receiving full treatment due to intolerance to PMZ-1620
Time frame: 160 days
Tolerability will be determined by the number of patients that do not receive all the 18 doses of PMZ-1620.
5 secondary outcomes
Changes in clinical progression of AD as measured by Mini-Mental State Examination (MMSE)
Time frame: 160 days
Changes in neuropsychiatric inventory (NPI) Score
Time frame: 160 days
Changes in Alzheimer's disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: 160 days
Changes in hippocampal atrophy using MRI/CT
Time frame: 160 days
Changes in electroencephalograms (EEGs)
Time frame: 160 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Background: PubMed 29947531Gulati A, Hornick MG, Briyal S, Lavhale MS. A novel neuroregenerative approach using ET(B) receptor agonist, IRL-1620, to treat CNS disorders. Physiol Res. 2018 Jun 27;67(Suppl 1):S95-S113. doi: 10.33549/physiolres.933859.
- Background: PubMed 26022359Briyal S, Nguyen C, Leonard M, Gulati A. Stimulation of endothelin B receptors by IRL-1620 decreases the progression of Alzheimer's disease. Neuroscience. 2015 Aug 20;301:1-11. doi: 10.1016/j.neuroscience.2015.05.044. Epub 2015 May 27.
- Background: PubMed 24561065Briyal S, Shepard C, Gulati A. Endothelin receptor type B agonist, IRL-1620, prevents beta amyloid (Abeta) induced oxidative stress and cognitive impairment in normal and diabetic rats. Pharmacol Biochem Behav. 2014 May;120:65-72. doi: 10.1016/j.pbb.2014.02.008. Epub 2014 Feb 20.
- Individual participant dataSharing planned: No. Results will be communicated and published as manuscript
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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.
Anil Gulati study chair
Pharmazz, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normal Saline along with standard treatment and PMZ-1620 (sovateltide) along with standard treatment in people with Alzheimer Disease and Dementia, run by Pharmazz, Inc. at 5 sites in India.
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 15 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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 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?
Incidence of PMZ-1620 related adverse events (time frame: 160 days). The study lists 2 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 NCT04052737, 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 12 Jan 2023.