A Prospective, Multicentric, Randomized, Double-blind, Parallel, Phase IV Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This is a prospective, multicenter, randomized, double-blind, parallel, phase IV study designed to evaluate the safety and efficacy of sovateltide (PMZ-1620, IRL-1620) as a potential treatment for cerebral ischemic stroke.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 78
Healthy Volunteers: f
View:
• Adult males or females aged 18 years through 78 years (have not had their 79th birthday)
• Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure.
• Stroke is ischemic in origin and radiologically confirmed Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) before enrolment. No hemorrhage as proved by cerebral CT/MRI scan.
• Cerebral ischemic stroke patients presenting within 24 hours after onset of symptoms with mRS score of 3-4 (pre-stroke mRS score of 0 or 1) and NIHSS score \>5 (NIHSS Level of Consciousness (1A) score must be \< 2). This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke.
• The patient is \<24 hours from the time of stroke onset when the first dose of Sovateltide therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self-reported to be normal.
• Reasonable expectation of availability to receive the full Sovateltide course of therapy and to be available for subsequent follow-up visits.
Locations
Other Locations
India
Radiant Superspeciality Hospital
RECRUITING
Amravati
KG Hospital and Post Graduate Medical Institute
RECRUITING
Coimbatore
Guntur Medical College and Government General Hospital
RECRUITING
Guntur
Lalitha Super Specialities Hospital Pvt. Ltd.
RECRUITING
Guntur
Maharani Laxmibai Medical College
RECRUITING
Jhānsi
Government Medical College and attached Hospitals
RECRUITING
Kota
Contact Information
Primary
Dharmesh Shah, Dr.
dharmesh.shah@pharmazz.com
+91(120)256-9779
Time Frame
Start Date:2024-01-08
Estimated Completion Date:2025-12
Participants
Target number of participants:160
Treatments
Experimental: Sovateltide (Tyvalzi™) + Standard treatment
A total of 80 patients will be enrolled in the experimental arm. Three doses of sovateltide (each dose of 0.3 μg/kg body weight) will be given as an IV bolus in each patient (randomly assigned to this group) over one minute at an interval of 3 ± 1 hours on day 1, day 3, and day 6 (total dose/day: 0.9 μg/kg body weight). All patients will receive standard stroke treatment as provided by the specific hospital setup. Patients will be closely monitored for the qualifying stroke, followed for 3 months, and assessed for safety and efficacy parameters. Efforts will be made to administer the drug at the same time on days 1, 3, and 6.
Placebo_comparator: Normal Saline (Dose: Equal volume) + Standard Treatment
A total of 80 patients will be enrolled in this arm. Three doses of an equal volume of normal saline will be administered as an IV bolus in each patient (randomly assigned to this group) over one minute at an interval of 3 ± 1 hours on day 1, day 3, and day 6. All patients will receive standard stroke treatment as provided by the specific hospital setup. Patients will be closely monitored for the qualifying stroke, followed for 3 months, and assessed for safety and efficacy parameters. Efforts will be made to administer the drug at the same time on days 1, 3, and 6.