NCT06176781

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With Acute Ischemic Stroke

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 880 (estimated)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 NIHSS score 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 ≤ 1 at 90 days after treatment. The secondary outcomes included mRS score on day 90, the proportion of subjects with mRS score ≤2 on day 90, the change of NIHSS score from baseline to day 14 and the proportion of subjects with NIHSS score ≤1 on day 14, 30, 90 after treatment. Safety outcomes included adverse events, treatment related adverse events within day 90, and changes in vital signs and laboratory data before and after treatment. Subjects in the Sequential group receive Edaravone Dexborneol concentrated solution for injections 37.5 mg BID administered intravenously for 5 - 10 days, and then followed by Edaravone Dexborneol Sublingual Tablets 30 mg BID administered sublingually for the last days, the total duration of treatment was 14 days. Subjects in the Placebo group receive placebo for 14 days. All the subjects were followed up to day 90 after the treatment.

Conditions

• Subjects With Acute Ischemic Stroke

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-28
• Primary completion: 2025-03-28
• Completion: 2025-05-30
• First posted: 2023-12-20
• Last updated: 2023-12-20