Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

NCT01851759 | Unknown Phase 2 DMC

• 1 other identifier: xijing005
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• modified Rankin scale

  3 month

Secondary Outcomes (1)

• Barthel index

  3 month

Study Arms (2)

Cinepazide, Stroke, Injection

EXPERIMENTAL

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

Drug: cinepazide

palcebo,Stroke,Injection

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

cinepazide DRUG

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.

Also known as: Methanesulfonic acid cinepazide injection

Cinepazide, Stroke, Injection

placebo DRUG

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.

Also known as: simulation agent of Methanesulfonic acid cinepazide

palcebo,Stroke,Injection

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

cinepazide

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gang Zhao, Doctor

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Zhao, Doctor

CONTACT

zhaogang@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 10, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

CN (1)