Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT06742216
Brief Summary:
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.
Study:
NCT06742216
Study Brief:
Protocol Section:
NCT06742216