Acute Ischemic StrokePhase 2NCT04453800
The Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke
A Phase 2 study testing sofadil【Neu2000KW】 and Sofadil in people with Acute Ischemic Stroke, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- sofadil【Neu2000KW】 and Sofadil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 1 Jan 2018
- 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
- The target population is 35-75 years old, regardless of gender;
- within 6h of onset, ischemic stroke of the internal carotid artery system;
- Neurological deficits, including limb weakness, with acute brain injury (NIHSS score) (4-22 points), or NIHSS item 5 upper limb or 6 lower limb score ≥2 points;
- Be able to initiate study treatment within 6 hours of onset of symptoms or within 6 hours of last appearing normal (6 hours after sleep in subjects with ischemic stroke who developed during sleep) and complete post-onset CT examination prior to study treatment;
- Obtain the informed consent signed by the subject or the subject's legal representative;
- MRS score before onset was 0~1;
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- Patients with no history of myocardial infarction within 3 months;
- Centerless, liver, kidney and lung dysfunction;
- No hemorrhagic disease within 3 months;
- No blood system diseases.
Who cannot join
- Any contraindications to CT or MRI (such as metal implants such as pacemaker, claustrophobia, etc
- Stroke caused by posterior circulation ischemia, or TIA;
- Acute intracranial hemorrhage, intracranial tumor, subarachnoid hemorrhage, encephalitis or other non-acute ischemic stroke (onset less than 6 hours), intracranial arteriovenous malformations;
- Patients who plan to undergo endovascular treatment, such as mechanical thrombectomy, stenting or arteriovenous bridging, within 6 hours after onset;
- Pregnant or lactating women. Note: The blood pregnancy test for fertile women before randomization must be negative and appropriate contraception should be used at least 3 weeks before randomization until 7 days after study drug infusion
- A pre-existing medical, neurological or psychiatric disorder that confuses neurological, functional or imaging assessments, such as persistent injury from previous ischemic stroke;
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- Patients with malignant tumors or other critical diseases;
- Having a history of epilepsy or having epileptiform symptoms at the onset of stroke;
- Previous history of intracranial hemorrhage;
- Patients with previous hypotension or blood pressure of less than 90/60mmhg measured for 3 consecutive times;
- Patients with severe injuries and surgical history within 3 months;
- People with consciousness disorder can be defined as "NIHSS score Ia ≥2 points";
- Bradycardia with complete atrioventricular block;
- According to the New York heart association (NYHA) grade of cardiac function, cardiac function rating above Ⅱ level, a history of congestive heart failure (CHF).
- Patients with primary liver and kidney diseases, AST or ALT twice as high as the normal upper limit, serum creatinine >2.0 mg/dL or >176.8 mol/L;
- Where the INR is greater than 1.7 or where an oral anticoagulant is currently used, except aspirin, clopidogrel, subcutaneous heparin or Wartamine;
- Patients with bleeding tendency diseases (such as hemophilia), and partial thromboplastin time (PTT) is more than 3 times of the normal upper limit;
- Having a current drug or alcohol problem or experience;
- Has the experience of allergic reaction to the research drugs or drugs with similar chemical structure;
- Participated in other clinical trials or clinical study participants within 3 months before the start of this study;
- The researcher considered it inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke
To evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke
Read the detailed description
The limited therapeutic time window for neuroprotection has prevented all clinical trials using NMDA receptor antagonists in subjects with ischemic stroke from showing efficacy. In animal models of ischemic stroke, antioxidants showed a longer neuroprotective time window than NMDA receptor antagonists, and also showed therapeutic potential in clinical trials in subjects with ischemic stroke. Sophadil showed good neuroprotective effects against NMDA and free-radical mediated cell death, NR2B-selectivity, moderate NMDA receptor antagonism, and effective cellular osmotic antioxidant activity even at nanoscale molarity. Non-clinical and phase I human clinical studies have shown that Sofadil is helpful in treating ischemic stroke subjects with better efficacy and therapeutic time windows. So we designed the clinical trial to evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke
- Conditions
- Acute Ischemic Stroke
- Being tested
- sofadil【Neu2000KW】, Sofadil, placebo
- Keywords
- Sofadil; Acute ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofadil【Neu2000KW】Drug
Also called low dose
500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
SofadilDrug
Also called Medium dose
750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
SofadilDrug
Also called high dose
1500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
placeboOther
Saline was administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Group A ：low dose sofadil | Experimental | 500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours Receives: Drug: sofadil【Neu2000KW】 |
| Group B: Medium dose group | Experimental | 750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours Receives: Drug: Sofadil |
| Group C: high dose group | Experimental | 1500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours Receives: Drug: Sofadil |
| Group D: placebo group | Placebo comparator | Saline was administered intravenously Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a NIHSS score
Proportion of subjects with a NIHSS score of 0 ~ 1 or 4 or more points less than baseline NIHSS at 14±2 days of treatment
Measured: 14±2 days of treatment
Secondary outcomes (1)
Changes in NIHSS score
Changes in NIHSS score at 14±2, 30±2, and 90±7 days after treatment compared to baseline
Measured: at 14±2, 30±2, and 90±7 days after treatment compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Oct 2016
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongsheng Fan, MD.PHD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453800
- Sponsor's protocol ID
- PUTH2017013
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04453800
- Acronym / sponsor ID
- PUTH2017013
- Conditions
- Acute Ischemic Stroke
- Keywords
- Sofadil; Acute ischemic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 1 Jul 2020 (actual)
- 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.
To evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke
Detailed description
The limited therapeutic time window for neuroprotection has prevented all clinical trials using NMDA receptor antagonists in subjects with ischemic stroke from showing efficacy. In animal models of ischemic stroke, antioxidants showed a longer neuroprotective time window than NMDA receptor antagonists, and also showed therapeutic potential in clinical trials in subjects with ischemic stroke. Sophadil showed good neuroprotective effects against NMDA and free-radical mediated cell death, NR2B-selectivity, moderate NMDA receptor antagonism, and effective cellular osmotic antioxidant activity even at nanoscale molarity. Non-clinical and phase I human clinical studies have shown that Sofadil is helpful in treating ischemic stroke subjects with better efficacy and therapeutic time windows. So we designed the clinical trial to evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A ：low dose sofadil | Experimental | Drug: sofadil【Neu2000KW】500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours |
| Group B: Medium dose group | Experimental | Drug: Sofadil750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours |
| Group C: high dose group | Experimental | Drug: Sofadil1500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours |
| Group D: placebo group | Placebo comparator | Other: placeboSaline was administered intravenously |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The target population is 35-75 years old, regardless of gender;
- within 6h of onset, ischemic stroke of the internal carotid artery system;
- Neurological deficits, including limb weakness, with acute brain injury (NIHSS score) (4-22 points), or NIHSS item 5 upper limb or 6 lower limb score ≥2 points;
- Be able to initiate study treatment within 6 hours of onset of symptoms or within 6 hours of last appearing normal (6 hours after sleep in subjects with ischemic stroke who developed during sleep) and complete post-onset CT examination prior to study treatment;
- Obtain the informed consent signed by the subject or the subject's legal representative;
Key exclusion criteria (21 listed)
- Any contraindications to CT or MRI (such as metal implants such as pacemaker, claustrophobia, etc
- Stroke caused by posterior circulation ischemia, or TIA;
- Acute intracranial hemorrhage, intracranial tumor, subarachnoid hemorrhage, encephalitis or other non-acute ischemic stroke (onset less than 6 hours), intracranial arteriovenous malformations;
- Patients who plan to undergo endovascular treatment, such as mechanical thrombectomy, stenting or arteriovenous bridging, within 6 hours after onset;
- Pregnant or lactating women. Note: The blood pregnancy test for fertile women before randomization must be negative and appropriate contraception should be used at least 3 weeks before randomization until 7 days after study drug infusion
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 |
|---|---|---|
| sofadil【Neu2000KW】Also: low dose500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours | Drug | Group A ：low dose sofadil |
| SofadilAlso: Medium dose750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours | Drug | Group B: Medium dose group |
| SofadilAlso: high dose1500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours | Drug | Group C: high dose group |
| placeboSaline was administered intravenously | Other | Group D: placebo group |
Primary outcome
Proportion of subjects with a NIHSS score
Time frame: 14±2 days of treatment
Proportion of subjects with a NIHSS score of 0 ~ 1 or 4 or more points less than baseline NIHSS at 14±2 days of treatment
1 secondary outcome
Changes in NIHSS score
Time frame: at 14±2, 30±2, and 90±7 days after treatment compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Dongsheng Fan, MD.PHD principal investigator
Peking University Third 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 sofadil【Neu2000KW】 and Sofadil in people with Acute Ischemic Stroke, run by Peking University Third 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 10 inclusion and 21 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: finished, as of the sponsor's last update on 1 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with a NIHSS score (time frame: 14±2 days of treatment). 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 1 Jul 2020.