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Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

Primary Purpose

Ischemic Stroke

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

cinepazide

placebo

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 40 and 75 years old，male/ female；
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）
Patients is proved by head skull CT and cerebral hemorrhage was excluded；
course of disease≤72h，the NIHSS score is ≥7 and ≤22；
Patients who voluntarily sign written informed consent. -

Exclusion Criteria:

Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack.
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 .
Patients who suffer from severe complications, and expected survival period is within three months.
Patients require thrombolysis, anticoagulation, anti- fibrosis treatment .
Patients who suffer from serious brain artery stenosis that should go through interventional therapy .
Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value .
Patients who have bleeding tendency or suffered from serious bleeding in 3 months.
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）.
Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system.
Patients who have complications of mental illness un can not or do not want willing to cooperate .
Doubt or does have alcohol, drug abuse history
Allergic constitution or allergic to the test drug ingredients .
Pregnancy and lactation women or those who has a recent fertility plan
Patients who have participated in other clinical experiments three months before this test.
The patients who is unsuitable to participate in the clinical test in the view of researchers

Sites / Locations

Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cinepazide, Stroke, Injection

palcebo,Stroke,Injection

Arm Description

Test drug：Methanesulfonic acid cinepazide injection（5ml/125mg）

Placebo：simulation agent of Methanesulfonic acid cinepazide injection（5ml sterile water for injection）

Outcomes

Primary Outcome Measures

modified Rankin scale

Secondary Outcome Measures

Barthel index

Full Information

NCT ID

NCT01851759

First Posted

May 7, 2013

Last Updated

May 7, 2013

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01851759

Brief Title

Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cinepazide, Stroke, Injection

Arm Type

Experimental

Arm Description

Test drug：Methanesulfonic acid cinepazide injection（5ml/125mg）

Arm Title

palcebo,Stroke,Injection

Arm Type

Placebo Comparator

Arm Description

Placebo：simulation agent of Methanesulfonic acid cinepazide injection（5ml sterile water for injection）

Intervention Type

Drug

Intervention Name(s)

cinepazide

Other Intervention Name(s)

Methanesulfonic acid cinepazide injection

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

simulation agent of Methanesulfonic acid cinepazide

Intervention Description

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.

Primary Outcome Measure Information:

Title

modified Rankin scale

Time Frame

3 month

Secondary Outcome Measure Information:

Title

Barthel index

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 40 and 75 years old，male/ female； 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） Patients is proved by head skull CT and cerebral hemorrhage was excluded； course of disease≤72h，the NIHSS score is ≥7 and ≤22； Patients who voluntarily sign written informed consent. - Exclusion Criteria: Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack. 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 . Patients who suffer from severe complications, and expected survival period is within three months. Patients require thrombolysis, anticoagulation, anti- fibrosis treatment . Patients who suffer from serious brain artery stenosis that should go through interventional therapy . Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value . Patients who have bleeding tendency or suffered from serious bleeding in 3 months. 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）. Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system. Patients who have complications of mental illness un can not or do not want willing to cooperate . Doubt or does have alcohol, drug abuse history Allergic constitution or allergic to the test drug ingredients . Pregnancy and lactation women or those who has a recent fertility plan Patients who have participated in other clinical experiments three months before this test. The patients who is unsuitable to participate in the clinical test in the view of researchers

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gang Zhao, Doctor

zhaogang@fmmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Zhao, Doctor

Organizational Affiliation

Xijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gang Zhao

Phone

02984775361

zhaogang@fmmu.edu.cn

12. IPD Sharing Statement

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Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

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