Using sodium valproate to treat acute ischemic stroke

Sodium Valproate in Patients With Acute Ischemic Stroke: a Pilot Randomized Trial

This study is testing if sodium valproate can help improve recovery in people who have just had an acute ischemic stroke by looking at its safety and effects on inflammation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06020898 on ClinicalTrials.gov

What this trial studies

This pilot trial aims to evaluate the feasibility, safety, and efficacy of sodium valproate in patients suffering from acute ischemic stroke. The study will investigate whether sodium valproate can enhance peripheral anti-inflammatory CD177+ neutrophil levels, which may contribute to its neuroprotective effects. Participants will be treated with sodium valproate or normal saline within 24 hours of stroke onset, and the study will help inform the design of future larger trials. The research is significant due to the limited effective treatment options currently available for ischemic stroke.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have been diagnosed with acute ischemic stroke and are not suitable for thrombolysis or mechanical thrombectomy.

Not a fit: Patients with a history of cerebral hemorrhage, severe hypertension, or contraindications to sodium valproate will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with acute ischemic stroke.

How similar studies have performed: While sodium valproate has shown potential neuroprotective effects in preclinical studies, this approach is novel in the context of acute ischemic stroke treatment.

Eligibility criteria

Inclusion Criteria:

1. 18≤age\<75 years;
2. Admitted to hospital within 24 hours after the onset of neurological impairment symptoms consequent to acute ischemic stroke diagnosed by CT or MRI;
3. Not suitable for thrombolysis and mechanical thrombectomy;
4. Written informed consent.

Exclusion Criteria:

1. mRS ≥ 2 before the disease onset;
2. Refractory hypertension (SBP\>180mmHg or DBP\>110mmHg after antihypertensive treatment);
3. History of cerebral hemorrhage, intracranial tumor, cerebral arteriovenous malformation and aneurysm;
4. History of brain trauma, intracranial or spinal surgery within 3 months, major surgery or severe physical trauma within 1 month;
5. Signs of infection at time of admission;
6. History of malignancy or active autoimmune disease;
7. Use of glucocorticoids or other immunosuppressive medications;
8. 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;
9. Use of medications containing active ingredients that can be converted to valproic acid, including sodium divalproate and valproamide;
10. Contraindications or intolerance for CT perfusion imaging;
11. Participating in other conflicting clinical trials;
12. Any other condition that investigators consider unsuitable such as mental illness, cognitive impairment, or inability to follow trial procedures.

Where this trial is running

Shanghai, Shanghai

• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Peiying Li, Doctor — RenJi Hospital
• Study coordinator: Peiying Li, Doctor

Conditions Acute Ischemic Stroke; Sodium valproate; Acute ischemic stroke