CClinicalTrials.gg
Sign In
Status unknownNCT01851759Updated May 10, 2013

Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction

A Phase 2 interventional study of cinepazide and placebo in Ischemic Stroke, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-05-10.

Sponsored by Xijing Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ischemic Stroke
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 288 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
288 participants (estimated)

Study arms

  • Experimental
    Cinepazide, Stroke, Injection

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

    Drug: cinepazide

  • Placebo comparator
    palcebo,Stroke,Injection

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

    Drug: placebo

Interventions

  • Drugcinepazide

    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

  • Drugplacebo

    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

06

What researchers measure

Primary outcomes

  1. modified Rankin scale

    Time frame: 3 month

Secondary outcomes

  1. Barthel index

    Time frame: 3 month

07

Study locations

1 site
  • Xijing Hospital
    Xi'an, Shaanxi 710032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01851759
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
May 10, 2013
Start date
Oct 2013
Primary completion
Aug 2014 (estimated)
Completion
Aug 2014 (estimated)
Last update
May 10, 2013

Study contacts

Gang Zhao, Doctor
Contact
zhaogang@fmmu.edu.cn
Gang Zhao, Doctor
principal investigator · Xijing Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Ischemic Stroke→

Other studies from this sponsor

Xijing Hospital

Start the discussion