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Acute StrokePhase 2NCT04046484

PMZ-1620 (Sovateltide) in Acute Ischemic Stroke Patients

A Phase 2 study testing Normal Saline along with standard treatment and PMZ-1620 along with standard treatment in people with Acute Stroke and Cerebral Ischemia, run by Pharmazz, Inc. at 7 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Stroke, Cerebral Ischemia
What is being tested?
Normal Saline along with standard treatment and PMZ-1620 along with standard treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
7 sitesIndia
Study dates
19 Jan 2018to 30 Jun 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult males or females Aged 18 years through 70 years (have not had their 71st birthday)
  • Signed and dated informed Consent from Legally Acceptable Representative, if subject is not in the condition to give consent. However, when the subject is stable and is able to give consent, consent would be obtained on a separate informed consent form to confirm his/her willingness to continue in the study
  • Stroke is ischemic in origin, supratentorial, and radiologically confirmed Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment
  • New (first time) cerebral ischemic strokes subjects presenting upto 24 hours after onset of symptoms (mRS score of 3-4) with a prestroke mRS score of 0 or 1 and NIHSS score of 5-14)
  • No hemorrhage as proved by cerebral CT/MRI scan
  • Subject is < 24 hours from time of stroke onset when the first dose of PMZ-1620 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when subject was last seen or was self- reported to be normal
Show all 12Show fewer
  • Reasonable expectation of availability to receive the full PMZ-1620 course of therapy, and to be available for subsequent follow-up visits
  • Subjects receiving thrombolytic therapy
  • Reasonable expectation that subject will receive standard post- stroke physical, occupational, speech, and cognitive therapy as indicated
  • Female subject is either:
  • Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or,
  • If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, OR A vasectomised partner OR abstinence

Who cannot join

  • Subjects receiving endovascular therapy
  • Subjects presenting with lacunar, hemorrhagic and/or brain stem stroke
  • Subjects classified as comatose, defined as a subject who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score must be < 2)
  • Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. (An episode of CHF is any heart failure that required a change in medication, change in diet or hospitalization)
  • Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH) on the baseline CT or MRI scan
  • Known valvular heart disease with CHF in the last 6 months
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  • Known (or in the Investigator's clinical judgment) existence of severe aortic stenosis or mitral stenosis
  • Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft, (CABG), valve replacement surgery) in the last 6 months
  • Subject is a candidate for any surgical intervention for treatment of stroke which may include but not limited to endovascular techniques
  • Subjects who are obese, body mass index (BMI) > 30 and/or on hormonal contraceptives
  • Hypo- or hyperglycemia sufficient to account for the neurological symptoms; patient should be excluded if their blood glucose is < 3.0 or > 20.0 mmol/L
  • Patient has systolic BP < 90 mmHg or > 220 mmHg or diastolic BP < 40 mmHg or > 130 mmHg
  • Acute myocardial infarction in the last 6 months
  • Signs or symptoms of acute myocardial infarction, including electrocardiogram findings, on admission
  • Concomitant treatment with neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational, neuroprotecti-ve substances)
  • Qualitative estimation of troponin on admission
  • Suspicion of aortic dissection on admission
  • Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on admission (systolic BP < 100 mmHg)
  • Findings on physical examination of any of the following: (1) jugular venous distention (JVP > 4 cm above the sternal angle); (2) 3rd heart sound; (3) resting tachycardia (heart rate > 100/min) attributable to CHF; (4) lower extremity pitting edema attributable to CHF; (5) bilateral rales; and/or (6) if a chest x-ray is performed, definite evidence of pulmonary edema, bilateral pleural effusion, or pulmonary vascular redistribution
  • Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy
  • Serum creatinine > 2.0 mg/dL or 180 μmol/L
  • Severe chronic anemia (hemoglobin < 7.5 g/dL)
  • Pregnancy, breastfeeding or positive pregnancy test. (Women of childbearing age must have a negative pregnancy test prior to study drug administration)
  • Concurrent participation in any other therapeutic clinical trial
  • Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, impair the assessment of outcome, or in which PMZ-1620 therapy would be contraindicated or might cause harm to the subject

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

India7 sites

  • Paras Hospital

    Gūrgaon, 122002

  • Nizam's Institute of Medical Sciences

    Hyderabad, 500082

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, 226014

  • Dayanand Medical College & Hospital

    Ludhiana, 141001

  • Department of Neurology, Christian Medical College and Hospital

    Ludhiana, 141008

  • New Era Hospital & Research Institute

    Nagpur, 440008

  • All India Institute of Medical Sciences

    New Delhi, 110029

Other trials in India

About this study

Official title: A Prospective, Multicentric, Randomized, Double Blind, Parallel, Saline Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy Along With Standard Supportive Care in Subjects of Acute Ischemic Stroke

This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute ischemic stroke.

Read the detailed description

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 when administered following ischemia.

Being tested
Normal Saline along with standard treatment, PMZ-1620 along with standard treatment
Medical subject headings
Stroke, Brain Ischemia

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

    The arm is for active comparison for PMZ-1620 (sovateltide), 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 cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.

  • PMZ-1620 along with standard treatmentDrug

    Also called Sovateltide (IRL-1620) along with standard treatment

    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 cerebral ischemic stroke patients.

Study groups in NCT04046484
Study groupRoleWhat they receive
Normal Saline (Dose: Equal volume) + Standard of careActive comparatorPatients 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, 3 and day 6 post randomization.
Receives: Drug: Normal Saline along with standard treatment
PMZ-1620 + Standard of careExperimentalPatients 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, 3, and day 6 (total dose/day: 0.9 µg/kg body weight).
Receives: Drug: PMZ-1620 along with standard treatment

What is being measured

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

  1. 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: 90 days

  2. Number of patients not receiving full treatment

    Tolerability will be determined by the number of patients that do not receive all the 9 doses of PMZ-1620.

    Measured: 90 days

Secondary outcomes (8)

  1. Change in National Institute of Health Stroke Scale (NIHSS)

    To determine whether PMZ-1620 therapy over and above standard of care increases the proportion of ischemic stroke subjects with National Institute of Health Stroke Scale (NIHSS) score ≥ 6 score at 3 months. NIHSS is 42 point scale where 0 is the best o and 42 is the worst outcome.

    Measured: 90 days

  2. Change in modified Rankin Scale (mRS)

    Neurological outcome as assessed by modified Rankin Scale (mRS) score ≤ 2 at 3 months post randomization. mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.

    Measured: 90 days

  3. Change in Barthel index [BI]

    Overall clinical outcome as assessed by Barthel index [BI] scores) at 3 months post randomization. BI is a 10 item scale with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.

    Measured: 90 days

  4. Change in EuroQol

    Quality-of-life (QoL) as assessed by EuroQol at 3 months post randomization. European quality of life is a five dimension instrument with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.

    Measured: 90 days

  5. Change in Stroke-Specific Quality of Life (SSQOL)

    Stroke-Specific Quality of Life (SSQOL) at 3 months post randomization. SSQOL is composed of 49 items with scores ranging from 49 to 245, where a score of 245 is the best and 49 is the worst outcome.

    Measured: 90 days

  6. Incidence in recurrence of ischemic stroke

    Incidence of recurrent ischemic stroke within 1 month and 3 months post randomization, as assessed by Questionnaire to Validate Stroke-Free Status (QVSFS)

    Measured: 90 days

  7. Incidence of mortality

    Incidence of mortality within 3 months post randomization

    Measured: 90 days

  8. Incidence of Intra-Cerebral Hemorrhage (ICH)

    Incidence of symptomatic Intra Cerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization

    Measured: 30 hours

Timeline

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

  1. First posted6 Aug 2019
  2. Study start19 Jan 2018
  3. Primary completion12 Apr 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight). 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, 3 and day 6 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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04046484
Sponsor's protocol ID
PMZ-01 Version 2.0/18
Other IDs
CTRI/2017/11/010654
Status last verified
May 2025
First submitted
31 Jul 2019
Last updated
12 May 2025
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

  • Leonard MG, Briyal S, Gulati A. Endothelin B receptor agonist, IRL-1620, provides long-term neuroprotection in cerebral ischemia in rats. Brain Res. 2012 Jun 29;1464:14-23. doi: 10.1016/j.brainres.2012.05.005. Epub 2012 May 9.

    PubMed 22580085

  • Leonard MG, Gulati A. Endothelin B receptor agonist, IRL-1620, enhances angiogenesis and neurogenesis following cerebral ischemia in rats. Brain Res. 2013 Aug 28;1528:28-41. doi: 10.1016/j.brainres.2013.07.002. Epub 2013 Jul 11.

    PubMed 23850649

  • Bhalla S, Leonard MG, Briyal S, Gulati A. Distinct Alteration in Brain Endothelin A and B Receptor Characteristics Following Focal Cerebral Ischemia in Rats. Drug Res (Stuttg). 2016 Apr;66(4):189-95. doi: 10.1055/s-0035-1559779. Epub 2015 Sep 23.

    PubMed 26398673

  • Briyal S, Ranjan AK, Hornick MG, Puppala AK, Luu T, Gulati A. Anti-apoptotic activity of ETB receptor agonist, IRL-1620, protects neural cells in rats with cerebral ischemia. Sci Rep. 2019 Jul 18;9(1):10439. doi: 10.1038/s41598-019-46203-x.

    PubMed 31320660

  • Cifuentes EG, Hornick MG, Havalad S, Donovan RL, Gulati A. Neuroprotective Effect of IRL-1620, an Endothelin B Receptor Agonist, on a Pediatric Rat Model of Middle Cerebral Artery Occlusion. Front Pediatr. 2018 Oct 23;6:310. doi: 10.3389/fped.2018.00310. eCollection 2018.

    PubMed 30406063

  • 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 29947531

  • Leonard MG, Briyal S, Gulati A. Endothelin B receptor agonist, IRL-1620, reduces neurological damage following permanent middle cerebral artery occlusion in rats. Brain Res. 2011 Oct 28;1420:48-58. doi: 10.1016/j.brainres.2011.08.075. Epub 2011 Sep 7.

    PubMed 21959172

  • Ranjan AK, Briyal S, Gulati A. Sovateltide (IRL-1620) activates neuronal differentiation and prevents mitochondrial dysfunction in adult mammalian brains following stroke. Sci Rep. 2020 Jul 29;10(1):12737. doi: 10.1038/s41598-020-69673-w.

    PubMed 32728189

  • Ranjan AK, Briyal S, Khandekar D, Gulati A. Sovateltide (IRL-1620) affects neuronal progenitors and prevents cerebral tissue damage after ischemic stroke. Can J Physiol Pharmacol. 2020 Sep;98(9):659-666. doi: 10.1139/cjpp-2020-0164. Epub 2020 Jun 23.

    PubMed 32574518

  • Gulati A, Agrawal N, Vibha D, Misra UK, Paul B, Jain D, Pandian J, Borgohain R. Safety and Efficacy of Sovateltide (IRL-1620) in a Multicenter Randomized Controlled Clinical Trial in Patients with Acute Cerebral Ischemic Stroke. CNS Drugs. 2021 Jan;35(1):85-104. doi: 10.1007/s40263-020-00783-9. Epub 2021 Jan 11.

    PubMed 33428177

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Normal Saline along with standard treatment and PMZ-1620 along with standard treatment in people with Acute Stroke and Cerebral Ischemia, run by Pharmazz, Inc. at 7 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 12 inclusion and 25 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 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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: 90 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 NCT04046484, which also lists 10 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 May 2025.

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