Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

Not yet recruiting

Phase 2 Results N/A

Trial Description

Using placebo as control, The purpose of this study is to evaluate the efficacy and safety of methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral infarction patients, and explore the best safe and effective dose as well as dose method.

Detailed Description

The study will enroll 288 acute cerebral infarction patients. Patients will be assigned randomly to receive either Methanesulfonic acid cinepazide injection or placebo treatment. All patient in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Barthel index score and modified Rankin scale assessments, will be done periodically until 90 days after onset. The degree of disabled improved will be a primary measure of drug effectiveness.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 2 branches of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. 1 branch of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.
    ARM 1: Kind: Experimental
    Label: palcebo,Stroke,Injection
    Description: Placebo:simulation agent of Methanesulfonic acid cinepazide injection(5ml sterile water for injection)
  • Cinepazide Drug
    Intervention Desc: 2 branches of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. 1 branch of simulation agent of Methanesulfonic acid cinepazide injection was matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.
    ARM 1: Kind: Experimental
    Label: Cinepazide, Stroke, Injection
    Description: Test drug:Methanesulfonic acid cinepazide injection(5ml/125mg)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin scale 3 month No
Secondary Barthel index 3 month No

Sponsors