Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPharmazz, Inc.
About this trial
Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult males or females aged 18 - 80 years of age.
Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.
A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and <20, NIHSS Level of Consciousness (1A) score <2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke having a pre-stroke historical measure of mRS score of 0-2.
Disqualifiers
Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques.
Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score ≥2).
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 pregnancy and lactating women.
Trial design
Design model
Parallel
Treatments tested in this trial
Drug: Normal Saline
DrugNormal saline to be used as vehicle in the phase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Sovateltide
DrugPhase-III study to assess efficacy of sovateltide in patients with acute cerebral ischemic stroke.
Treatment groups
514 Participants
are divided into 2 treatment groupsGroup A: Normal Saline + Standard of careActive comparator 1 intervention
Group B: Sovateltide + Standard of careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determine the efficacy of sovateltide in patients with acute cerebral ischemic stroke assessed by modified Rankin Scale (mRS) score of 0-2 at day 90 post-randomization.
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with a modified Rankin Scale score of 0-2 on day 90 post-randomization.
Time frame
Day 1 through Day 90Secondary outcomes
1
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the National Institute of Health Stroke Scale (NIHSS) score of <6 at day 90 post-randomization.
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of \<6 on day 90 post-randomization.
Time frame
Day 1 through Day 902
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the Barthel Index (BI) score of ≥90 at day 90 post-randomization.
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 90 post-randomization.
Time frame
Day 1 through Day 903
Determine an excellent functional outcome in patients with acute cerebral ischemic stroke assessed by a modified Rankin Scale score of 0-1 at day 90 post-randomization.
The proportion of acute cerebral ischemic stroke patients having an excellent functional outcome with a modified Rankin Scale score of 0-1 on day 90 post-randomization.
Time frame
Day 1 through Day 904
Determine a change in Quality-of-life (QoL) as assessed by EuroQol-EQ-5D-5L and Stroke-Specific Quality of Life (SS-QOL) at days 30, 60, and 90 post-randomization.
Change in QoL as assessed by EuroQol EQ-5D-5L and by SS-QOL from baseline to days 30, 60, and 90 post-randomization.
Time frame
Day 1 through Day 90Other outcomes
1
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by mRS score of 0-2 at day 30 post-randomization.
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with a mRS score of 0-2 on day 30 post-randomization.
Time frame
Day 1 through Day 302
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the NIHSS score of <6 at day 30 post-randomization.
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of \<6 on day 30 post-randomization.
Time frame
Day 1 through Day 303
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the BI score of ≥90 at day 30 post-randomization.
The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 30 post-randomization.
Time frame
Day 1 through Day 304
Determine Alberta Stroke Program Early CT (ASPECT) Score for stroke severity at baseline and identify sites of ischemic lesions.
Compare baseline Alberta Stroke Program Early CT (ASPECT) Score for stroke severity and identify sites of ischemic lesions.
Time frame
Day 1 through Day 90Sponsors and contacts
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Source ClinicalTrials.gov