Assesment of Safety and efficacy of the drug called sovateltide in patients with acute cerebral ischemic stroke patients

Safety and efficacy of sovateltide in acute cerebral ischemic stroke patients at a tertiary care centre-a double blinded block randomised placebo controlled study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070459

Enrollment

Registered

2024-07-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I639- Cerebral infarction, unspecified

Interventions

Intervention1: SOVATELTIDE: Three doses of sovateltide at an interval of 3 hours on day 1, day 3 and day 6 (total dose of 0.9 µg/kg/day). Intravenous route at a dose of 0.3 µg/kg (each dose) administ

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients presenting within 24 hours from the onset of stroke symptoms. 2.Stroke patients with modified rankin score of 3-4 and national institute of stroke scale score of 5-25 3.Stroke patients with radiological confirmation of stroke.

Exclusion criteria

Exclusion criteria: 1.Patients with intracranial haemorrhage. 2.Patient with ischemic heart disease 3.Chronic liver and renal failure 4.Patients who are planning for Endovascular therapy. 5.Patients with sepsis. 6.Pregnant women. 7.Breast feeding women. 8.Stroke mimics

Design outcomes

Primary

Measure	Time frame
Improvement In Mondified Rankin score and NIHS scoreTimepoint: Basline, 15th day and 90th day	—

Secondary

Measure	Time frame
Adverse effects of SovateltideTimepoint: 90 day	—

Countries

India

Contacts

Public ContactShobana Sundaram

Pondicherry Institute of Medical Sciences

shobanadmneuro@gmail.com7639505001

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026