Clinical trial NCT01851759: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ischemic Stroke
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 288
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: modified Rankin scale
timeFrame: 3 month
Secondary outcomes:
measure: Barthel index
timeFrame: 3 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Gang Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: