Ischemic StrokePhase 2NCT02059785
Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke
A Phase 2 study testing Pinocembrin for Injection in people with Ischemic Stroke, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Pinocembrin for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2016
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35-75 hospitalized patients
- Patients with acute stroke ≤24h
- NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6
- For the first time or always without obvious sequelae of stroke disease(mRS≤1）
- Informed consent
Who cannot join
- The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms
- Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study
- TIA
- Symptoms of disease rapidly improving during the randomized
- Severe hypertension(SBP > 200 mmHg or DBP >110 mmHg)
- Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance <60ml/min）
Show all 12Show fewer
- Severe system or viscera organic disease
- Have used other neuroprotectant or other experimental drugs
- Patient who are unlikely to complete the study that due to a severe clinical condition
- Pregnant or breast-feeding
- Participation in a previous clinical study within 30 days
- Meets all other exclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital affilliated to Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study
This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.
Read the detailed description
Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.
- Conditions
- Ischemic Stroke
- Being tested
- Pinocembrin for Injection
- Keywords
- Pinocembrin for Injection, Placebo, mRS
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pinocembrin for InjectionDrug
Also called DL0108
| Study group | Role | What they receive |
|---|---|---|
| Pinocembrin for Injection | Experimental | 40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day Receives: Drug: Pinocembrin for Injection |
| placebo | Placebo comparator | 60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day Receives: Drug: Pinocembrin for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days
Measured: 90 days
Secondary outcomes (1)
To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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 CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang Yong Jun, Ph.D, Study director, Beijing Tiantan Hospital affilliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059785
- Sponsor's protocol ID
- CSPC-HA1301
- Status last verified
- Oct 2015
- First submitted
- 7 Feb 2014
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT02059785
- Acronym / sponsor ID
- CSPC-HA1301
- Conditions
- Ischemic Stroke
- Keywords
- Pinocembrin for Injection, Placebo, mRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Feb 2014 (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.
This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.
Detailed description
Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pinocembrin for Injection | Experimental | Drug: Pinocembrin for Injection40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day |
| placebo | Placebo comparator | Drug: Pinocembrin for Injection60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 35-75 hospitalized patients
- Patients with acute stroke ≤24h
- NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6
- For the first time or always without obvious sequelae of stroke disease(mRS≤1）
- Informed consent
Key exclusion criteria (12 listed)
- The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms
- Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study
- TIA
- Symptoms of disease rapidly improving during the randomized
- Severe hypertension(SBP > 200 mmHg or DBP >110 mmHg)
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 |
|---|---|---|
| Pinocembrin for InjectionAlso: DL0108 | Drug | Pinocembrin for Injection, placebo |
Primary outcome
To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days
Time frame: 90 days
1 secondary outcome
To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
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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.
Wang Yong Jun, Ph.D study director
Beijing Tiantan Hospital affilliated to Capital Medical University
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 Pinocembrin for Injection in people with Ischemic Stroke, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 12 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: paused, as of the sponsor's last update on 20 Jun 2016. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days (time frame: 90 days). 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 20 Jun 2016.