MedTrace Logo

The Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With AIS

NCT06176781 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2023-12-20

No results posted yet for this study

Summary

SIM0308-302 is a multicenter, randomized, double-blind, placebo-controlled clinical III trial with the primary objective of evaluating the efficacy of Edaravone Dexborneol sequential therapy, consisting of Edaravone Dexborneol Injections followed by Edaravone Dexborneol Sublingual Tablets for total 14 days, in patients with acute ischemic stroke (AIS). The subject has a clinical diagnosis of AIS, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with modified Rankin scale score ≤ 2 at 90 days after treatment.

Conditions

  • Subjects With Acute Ischemic Stroke

Interventions

DRUG

Edaravone Dexborneol Sequential Therapy

Sequential treatment started with intravenous injection of edaravone dextrocamphorol 37.5 mg, twice a day for 5-10 days. Then, Edaravone Dexborneol Sublingual Tablets 36.0 mg was taken sublingual twice a day for 14 days (the total course of the two drugs was 14 days, a total of 28 times).

DRUG

Placebo

Injection Simulants(Edaravone Dexborneol concentrated solution for injections) administered intravenously for 5 - 10 days, and then followed by Sublingual Tablet Simulants(Edaravone Dexborneol Sublingual Tablets) BID administered sublingually for the last days, the total duration of treatment was 14 days

Sponsors & Collaborators

  • Simcere Pharmaceutical Co., Ltd

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2025-03-28
Completion
2025-05-30

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06176781 on ClinicalTrials.gov