Who is sponsoring NCT06742216?

NCT06742216 is sponsored by Qilu Pharmaceutical Co., Ltd..

What drugs are being tested in NCT06742216?

Interventions in NCT06742216: Monosialoganglioside, Placebo.

What condition does NCT06742216 study?

NCT06742216 studies Acute Ischemic Stroke.

Is NCT06742216 still recruiting?

NCT06742216 is currently completed. Last updated 19 December 2024.

Last reviewed 2024-12-19 · How we verify

NCT06742216

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Monosialoganglioside in Acute Ischemic Stroke: a Randomized, Blinded and Multicenter Confirmatory Study

Completed Phase 3 Last updated 19 December 2024

What this trial tests

Phase 3 trial testing Monosialoganglioside in Acute Ischemic Stroke in 1,232 participants. Completed in 30 August 2023.

Timeline

3 November 2020

Primary endpoint
30 August 2023

30 August 2023

Quick facts

Lead sponsor	Qilu Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,232
Start date	3 November 2020
Primary completion	30 August 2023
Estimated completion	30 August 2023
Sites	1 location across China

Drugs / interventions tested

Monosialoganglioside — full drug profile →
Placebo

Conditions studied

Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

Qilu Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 80, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A multicenter, randomized, double-blind, parallel, placebo-controlled trial design is used to evaluate the efficacy and safety of GM1 injection in the treatment of patients with acute ischemic stroke. It is estimated that 1706 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 1:1 ratio. Normally, the duration of this study is approximately 90 days. Treatment was continued for 12\~14 days, and follow-up was conducted until the 90th day from the first dose. The trial is divided into three phases: screening/baseline phase, treatment phase, and follow-up phase. Screening/baseline period: After the subjects sign the informed consent form, they enter the screening/baseline period for screening examination. Treatment period: Qualified subjects are randomly divided into groups in a 1:1 ratio and receive continuous treatment for 12\~14 days (12\~14 times) with GM1 injection and placebo respectively. During the treatment period, relevant examinations and evaluations required by the protocol will be carried out. Follow-up period: Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Acute Ischemic Stroke

Currently open trials in the same condition.

NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
NCT07404852 — Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemi · NA · recruiting
NCT07361302 — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Pe · Phase 3 · recruiting
NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
NCT07203625 — Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours · Phase 4 · recruiting

Other Qilu Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07511647 — A Phase 3 Clinical Study of QL2106 Injection · Phase 3 · not yet recruiting
NCT07467629 — QLS5212 for Participants With Advanced Solid Tumors · Phase 1 · not yet recruiting
NCT07455006 — Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Phase 3 · not yet recruiting
NCT07463573 — QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma · Phase 3 · not yet recruiting
NCT07444086 — QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06742216 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Qilu Pharmaceutical Co., Ltd.
Last refreshed: 19 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06742216.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing