Ischemic StrokePhase 2NCT01851759
Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction
A Phase 2 study testing cinepazide in people with Ischemic Stroke, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- cinepazide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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 .
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- 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
Trial locations and contacts
1 site in 1 country.
Gang Zhao, Doctor contact
China1 site
Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Zhao, 02984775361, zhaogang@fmmu.edu.cn
About this study
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
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.
- Conditions
- Ischemic Stroke
- Being tested
- cinepazide, placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinepazideDrug
Also called Methanesulfonic acid cinepazide injection
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.
placeboDrug
Also called simulation agent of Methanesulfonic acid cinepazide
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.
| Study group | Role | What they receive |
|---|---|---|
| Cinepazide, Stroke, Injection | Experimental | Test drug：Methanesulfonic acid cinepazide injection（5ml/125mg） Receives: Drug: cinepazide |
| palcebo,Stroke,Injection | Placebo comparator | Placebo：simulation agent of Methanesulfonic acid cinepazide injection（5ml sterile water for injection） Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale
Measured: 3 month
Secondary outcomes (1)
Barthel index
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, Doctor, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851759
- Sponsor's protocol ID
- xijing005
- Status last verified
- May 2013
- First submitted
- 7 May 2013
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01851759
- Acronym / sponsor ID
- xijing005
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinepazide, Stroke, Injection | Experimental | Drug: cinepazideTest drug：Methanesulfonic acid cinepazide injection（5ml/125mg） |
| palcebo,Stroke,Injection | Placebo comparator | Drug: placeboPlacebo：simulation agent of Methanesulfonic acid cinepazide injection（5ml sterile water for injection） |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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. -
Key exclusion criteria (15 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cinepazideAlso: Methanesulfonic acid cinepazide injection2 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. | Drug | Cinepazide, Stroke, Injection |
| placeboAlso: simulation agent of Methanesulfonic acid cinepazide2 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. | Drug | palcebo,Stroke,Injection |
Primary outcome
modified Rankin scale
Time frame: 3 month
1 secondary outcome
Barthel index
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Zhao, Doctor contact
Gang Zhao, Doctor principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cinepazide in people with Ischemic Stroke, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Zhao, Doctor (zhaogang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.