Acute Ischemic StrokePhase 2NCT06020898
Sodium Valproate in Patients With Acute Ischemic Stroke
A Phase 2 study testing Sodium valproate and Normal saline in people with Acute Ischemic Stroke, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this pilot trial is to investigate the feasibility, safety, and efficacy of sodium valproate in patients with acute ischemic stroke, and also explore the mechanism: whether valproate increases peripheral anti-inflammatory CD177+ neutrophil levels. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Sodium valproate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Apr 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18≤age<75 years;
- Admitted to hospital within 24 hours after the onset of neurological impairment symptoms consequent to acute ischemic stroke diagnosed by CT or MRI;
- Not suitable for thrombolysis and mechanical thrombectomy;
- Written informed consent.
Who cannot join
- mRS ≥ 2 before the disease onset;
- Refractory hypertension (SBP>180mmHg or DBP>110mmHg after antihypertensive treatment);
- History of cerebral hemorrhage, intracranial tumor, cerebral arteriovenous malformation and aneurysm;
- History of brain trauma, intracranial or spinal surgery within 3 months, major surgery or severe physical trauma within 1 month;
- Signs of infection at time of admission;
- History of malignancy or active autoimmune disease;
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- Use of glucocorticoids or other immunosuppressive medications;
- Contraindications to sodium valproate: pregnancy; liver disease or severe hepatic insufficiency (ALT, AST 3 times higher than the upper normal limit); hemorrhagic risk (such as platelet count <100x109/L, APTT≥35s); allergy to sodium valproate, sodium divalproate, or valproamide; hepatic porphyria; combined use of mefloquine; mitochondrial diseases related to POLG mutations; known disorders of the urea cycle;
- Use of medications containing active ingredients that can be converted to valproic acid, including sodium divalproate and valproamide;
- Contraindications or intolerance for CT perfusion imaging;
- Participating in other conflicting clinical trials;
- Any other condition that investigators consider unsuitable such as mental illness, cognitive impairment, or inability to follow trial procedures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Peiying Li, Doctor, +8615800616866, peiyingli.md@gmail.com
About this study
Official title: Sodium Valproate in Patients With Acute Ischemic Stroke: a Pilot Randomized Trial
The purpose of this pilot trial is to investigate the feasibility, safety, and efficacy of sodium valproate in patients with acute ischemic stroke, and also explore the mechanism: whether valproate increases peripheral anti-inflammatory CD177+ neutrophil levels.
Read the detailed description
Ischemic stroke is one of the leading causes of disability and mortality worldwide, which imposes a huge burden on families and society. Currently, the effective treatment strategies of ischemic stroke are limited. It is of great clinical value and significance to explore effective neuroprotective medications besides reperfusion therapy.
Sodium valproate is widely used in clinical practice, and its safety and tolerability has been confirmed. It is mainly used in the treatment of epilepsy, bipolar disorder, neuropathic pain and other diseases. In recent years, a number of preclinical studies have found that valproic acid has a potential neuroprotective effect in acute ischemic brain injury, which can decrease infarct volume, reduce blood-brain barrier damage, and improve neurological function. However, the neuroprotective mechanism of sodium valproate has not been fully revealed, and there is still a lack of clinical studies to clarify the neuroprotective effect of sodium valproate in patients with ischemic stroke.
The goal of this study is to test whether sodium valproate could become a new therapeutic approach for ischemic stroke. This prospective pilot study is intended to investigate the feasibility, safety, and efficacy of sodium valproate in patients with acute ischemic stroke, thus support the estimate of sample size for a future full trial. In addition, we will test the hypotheses that valproate increases peripheral anti-inflammatory CD177+ neutrophil levels.
Patients with acute ischemic stroke included in the study will be randomly assigned to sodium valproate group (20 mg/kg/d) or saline placebo group. Treatment will be started within 24 hours after stroke onset. The trial drug will be given intravenously for 3 consecutive days. The investigators evaluate whether sodium valproate can improve clinical outcomes and increase peripheral CD177+ neutrophil levels.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Sodium valproate, Normal saline
- Keywords
- Sodium valproate, 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.
Sodium valproateDrug
Patients with acute ischemic stroke included in the study are randomly assigned to low-dose sodium valproate group, high-dose sodium valproate group and placebo group. Besides receiving conventional treatment for stroke, 10mg/kg sodium valproate, 20mg/kg sodium valproate or normal saline were given intravenously for 3 consecutive days, respectively.
Normal salineDrug
Patients with acute ischemic stroke included in the study are randomly assigned to low-dose sodium valproate group, high-dose sodium valproate group and placebo group. Besides receiving conventional treatment for stroke, 10mg/kg sodium valproate, 20mg/kg sodium valproate or normal saline were given intravenously for 3 consecutive days, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Sodium valproate group | Experimental | Within 3 days after admission, 20mg/kg sodium valproate will be given daily. Specifically, 400mg sodium valproate will be infused within 5 minutes, followed by intravenous drip with 1mg/kg/h. Receives: Drug: Sodium valproate |
| Placebo group | Placebo comparator | Within 3 days after admission, normal saline will be given daily in the same way. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable outcome at 90 days (the Modified Rankin Scale (mRS) score≤2)
The proportion of patients with favorable outcome, which is defined as the Modified Rankin Scale (mRS) score 0-2.
Measured: Day 90
Secondary outcomes (4)
Favorable outcome at 30 days (the Modified Rankin Scale (mRS) score≤2)
The proportion of patients with favorable outcome, which is defined as the Modified Rankin Scale (mRS) score 0-2.
Measured: Day 30
NIH Stroke Scale (NIHSS) score at 3 days
The NIH Stroke Scale (NIHSS) score ranges from 0 to 42, where high scores mean a worse outcome.
Measured: Day 3
NIH Stroke Scale (NIHSS) score at 7 days
The NIH Stroke Scale (NIHSS) score ranges from 0 to 42, where high scores mean a worse outcome.
Measured: Day 7
Changes of lesion volume from baseline to day 7
The infarct lesion volume will be measures on magnetic resonance imaging DWI and FLAIR.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
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 RenJi 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiying Li, RenJi Hospital
- Investigators
- Peiying Li, Doctor, Principal investigator, RenJi HospitalJieqing Wan, Doctor, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020898
- Sponsor's protocol ID
- LY2023-138-A
- Status last verified
- Feb 2024
- First submitted
- 14 Aug 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Valproate in Patients With Acute Ischemic Stroke: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT06020898
- Acronym / sponsor ID
- LY2023-138-A
- Conditions
- Acute Ischemic Stroke
- Keywords
- Sodium valproate, Acute ischemic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 1 Sep 2023 (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.
The purpose of this pilot trial is to investigate the feasibility, safety, and efficacy of sodium valproate in patients with acute ischemic stroke, and also explore the mechanism: whether valproate increases peripheral anti-inflammatory CD177+ neutrophil levels.
Detailed description
Ischemic stroke is one of the leading causes of disability and mortality worldwide, which imposes a huge burden on families and society. Currently, the effective treatment strategies of ischemic stroke are limited. It is of great clinical value and significance to explore effective neuroprotective medications besides reperfusion therapy.
Sodium valproate is widely used in clinical practice, and its safety and tolerability has been confirmed. It is mainly used in the treatment of epilepsy, bipolar disorder, neuropathic pain and other diseases. In recent years, a number of preclinical studies have found that valproic acid has a potential neuroprotective effect in acute ischemic brain injury, which can decrease infarct volume, reduce blood-brain barrier damage, and improve neurological function. However, the neuroprotective mechanism of sodium valproate has not been fully revealed, and there is still a lack of clinical studies to clarify the neuroprotective effect of sodium valproate in patients with ischemic stroke.
The goal of this study is to test whether sodium valproate could become a new therapeutic approach for ischemic stroke. This prospective pilot study is intended to investigate the feasibility, safety, and efficacy of sodium valproate in patients with acute ischemic stroke, thus support the estimate of sample size for a future full trial. In addition, we will test the hypotheses that valproate increases peripheral anti-inflammatory CD177+ neutrophil levels.
Patients with acute ischemic stroke included in the study will be randomly assigned to sodium valproate group (20 mg/kg/d) or saline placebo group. Treatment will be started within 24 hours after stroke onset. The trial drug will be given intravenously for 3 consecutive days. The investigators evaluate whether sodium valproate can improve clinical outcomes and increase peripheral CD177+ neutrophil levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium valproate group | Experimental | Drug: Sodium valproateWithin 3 days after admission, 20mg/kg sodium valproate will be given daily. Specifically, 400mg sodium valproate will be infused within 5 minutes, followed by intravenous drip with 1mg/kg/h. |
| Placebo group | Placebo comparator | Drug: Normal salineWithin 3 days after admission, normal saline will be given daily in the same way. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18≤age<75 years;
- Admitted to hospital within 24 hours after the onset of neurological impairment symptoms consequent to acute ischemic stroke diagnosed by CT or MRI;
- Not suitable for thrombolysis and mechanical thrombectomy;
- Written informed consent.
Key exclusion criteria (12 listed)
- mRS ≥ 2 before the disease onset;
- Refractory hypertension (SBP>180mmHg or DBP>110mmHg after antihypertensive treatment);
- History of cerebral hemorrhage, intracranial tumor, cerebral arteriovenous malformation and aneurysm;
- History of brain trauma, intracranial or spinal surgery within 3 months, major surgery or severe physical trauma within 1 month;
- Signs of infection at time of admission;
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 |
|---|---|---|
| Sodium valproatePatients with acute ischemic stroke included in the study are randomly assigned to low-dose sodium valproate group, high-dose sodium valproate group and placebo group. Besides receiving conventional treatment for stroke, 10mg/kg sodium valproate, 20mg/kg sodium valproate or normal saline were given intravenously for 3 consecutive days, respectively. | Drug | Sodium valproate group |
| Normal salinePatients with acute ischemic stroke included in the study are randomly assigned to low-dose sodium valproate group, high-dose sodium valproate group and placebo group. Besides receiving conventional treatment for stroke, 10mg/kg sodium valproate, 20mg/kg sodium valproate or normal saline were given intravenously for 3 consecutive days, respectively. | Drug | Placebo group |
Primary outcome
Favorable outcome at 90 days (the Modified Rankin Scale (mRS) score≤2)
Time frame: Day 90
The proportion of patients with favorable outcome, which is defined as the Modified Rankin Scale (mRS) score 0-2.
4 secondary outcomes
Favorable outcome at 30 days (the Modified Rankin Scale (mRS) score≤2)
Time frame: Day 30
NIH Stroke Scale (NIHSS) score at 3 days
Time frame: Day 3
NIH Stroke Scale (NIHSS) score at 7 days
Time frame: Day 7
Changes of lesion volume from baseline to day 7
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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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.
Peiying Li, Doctor principal investigator
RenJi Hospital
Jieqing Wan, Doctor principal investigator
RenJi 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 Sodium valproate and Normal saline in people with Acute Ischemic Stroke, run by RenJi 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 4 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. 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 Peiying Li, Doctor (+8615800616866, peiyingli.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable outcome at 90 days (the Modified Rankin Scale (mRS) score≤2) (time frame: Day 90). 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 21 Feb 2024.