Trial intelligence / Profile preview

Sovateltide in Acute Cerebral Ischemic Stroke

NCT05691244Phase 3

Key facts

Status: Recruiting
Start: Jul 2025
Primary completion: Sep 2027
Countries: 4
Sponsor: Pharmazz, Inc.
Modality: Peptides, Small Molecules

Drugs: sovateltide
Conditions: ischemic stroke

Overview

Phase 3, randomised, double-blind trial in ischemic stroke comparing Normal Saline + Standard of care with Sovateltide + Standard of care (2 arms). Primary endpoint: Modified Rankin Scale at 90 days. Started Jul 2025; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Normal Saline + Standard of care
Normal saline IV bolus over 1 min every 3 hours on day 1, repeated on days 3 and 6.
Sovateltide + Standard of care
Sovateltide 0.3 μg/kg IV bolus over 1 min every 3 hours on day 1, repeated on days 3 and 6.

Who it enrols

Adults 18-80 years with acute ischemic stroke presenting within 24 hours of symptom onset, NIHSS 8-19, and not candidates for endovascular therapy.

Endpoints

Primary

Modified Rankin Scale90 days

Secondary

National Institute of Health Stroke Scale90 days
Barthel Index90 days
Modified Rankin Scale90 days
Quality of Life90 days
Incidence of recurrent cerebral ischemic stroke90 days
Incidence of mortality90 days
Symptomatic Intracerebral Hemorrhage24 hours
Radiographic Intracerebral Hemorrhage24 hours

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