Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

A Random, Double-blind, Placebo- Controlled and Dose-finding, Multi-center, Phase II Clinical Trial of Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: cinepazide; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 40 and 75 years old，male/ female；
2. The clinical diagnosis of first onset patients with anterior circulation infarction or who have suffered from stroke in history and complete recover from neurologic impairment (mRS score <2 before this disease）
3. Patients is proved by head skull CT and cerebral hemorrhage was excluded；
4. course of disease≤72h，the NIHSS score is ≥7 and ≤22；
5. Patients who voluntarily sign written informed consent. -

Exclusion Criteria:

1. Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack.
2. Patients who suffer from brain arteritis, brain tumor, brain injury, intracranial infection, brain parasitic disease, and so on . Patients who suffer from cardiac diseases such as rheumatic heart disease, coronary heart disease with atrial fibrillation .
3. Patients who suffer from severe complications, and expected survival period is within three months.
4. Patients require thrombolysis, anticoagulation, anti- fibrosis treatment .
5. Patients who suffer from serious brain artery stenosis that should go through interventional therapy .
6. Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value .
7. Patients who have bleeding tendency or suffered from serious bleeding in 3 months.
8. Patients who have severe cardiac, liver and kidney disease, or whose kidney and liver function tests was abnormal（ALT,AST≥1.5 times of upper normal limit，Cr>upper normal limit）.
9. Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system.
10. Patients who have complications of mental illness un can not or do not want willing to cooperate .
11. Doubt or does have alcohol, drug abuse history
12. Allergic constitution or allergic to the test drug ingredients .
13. Pregnancy and lactation women or those who has a recent fertility plan
14. Patients who have participated in other clinical experiments three months before this test.
15. The patients who is unsuitable to participate in the clinical test in the view of researchers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cinepazide, Stroke, Injection; Test drug：Methanesulfonic acid cinepazide injection（5ml/125mg）	Drug: cinepazide; 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.; Other Names: Methanesulfonic acid cinepazide injection
Placebo Comparator: palcebo,Stroke,Injection; Placebo：simulation agent of Methanesulfonic acid cinepazide injection（5ml sterile water for injection）	Drug: placebo; 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.; Other Names: simulation agent of Methanesulfonic acid cinepazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
modified Rankin scale	3 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Barthel index	3 month

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Gang Zhao, Doctor, Xijing Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 10, 2013

Study Record Updates

• Last Update Posted (Estimate): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 7, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Ischemic Stroke; Cerebral Infarction; Vasodilator Agents; Cinepazide
• Other Study ID Numbers: xijing005