Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01851759
• Other study ID #: xijing005
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 7, 2013
• Last updated: May 7, 2013
• Start date: October 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2013
• Source: Xijing Hospital
• Contact: Gang Zhao, Doctor
• Email: zhaogang[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 288
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemic Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin scale		3 month	No
Secondary	Barthel index		3 month	No