L-Oxiracetam injection for improving memory after brain injury

A Randomized, Double-blind, Positive Drug/Placebo Parallel Controlled, Multicenter, Phase III Clinical Trial of L-oxiracetam Injection to Improve Memory and Cognitive Impairment in Patients With Craniocerebral Injury

This study tests if an injection of L-oxiracetam can help improve memory and thinking skills in people who have had mild to moderate brain injuries.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 591 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing Yoko Biomedical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tianjing, Tianjing)
• Trial ID: NCT04205565 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial evaluates the effectiveness of L-oxiracetam injection in enhancing memory and cognitive function in patients who have suffered craniocerebral injuries. The study employs a randomized, double-blind, placebo-controlled design, with participants receiving either the L-oxiracetam injection, a control oxiracetam injection, or a placebo. The trial aims to assess cognitive improvements within 72 hours post-injury in patients with mild to moderate brain injuries confirmed by MRI or CT scans.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have sustained mild to moderate craniocerebral injuries and exhibit cognitive impairment.

Not a fit: Patients with known allergies to the study drug or those with severe cognitive impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cognitive recovery in patients with craniocerebral injuries.

How similar studies have performed: Previous studies on cognitive enhancers in brain injury have shown promise, but the specific use of L-oxiracetam in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years old (including upper and lower limits), male or female
2. Craniocerebral injury meets all of the following conditions: This diagnosis has a clear head trauma, closed head injury, or head injury with cerebrospinal fluid ear leak and / or nasal leak and / or intracranial gas accumulation; MRI or CT confirmed intracranial hemorrhage above the cerebellum (including cerebral contusion, subarachnoid hemorrhage, epidural hematoma, subdural hemorrhage, intracranial hematoma, etc.), with or without transient coma; Craniocerebral injury is classified as mild or moderate (GCS score 10-15 points); Conservative treatment.
3. Within 72 hours after head injury, patients with stable and mentally handicapped mental state examination (MMSE) scores are lower than normal.
4. The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

1. People who are known or suspected to be allergic to the test drug and its ingredients.
2. After the injury, drugs that improve cognitive function such as the prohibited drugs listed in the protocol have been used.
3. With a history of severe traumatic brain injury, a history of cerebrovascular accidents, and structural craniocerebral lesions.
4. With diseases such as speech and hearing impairment that cannot cooperate with the completion of cognitive function assessment.
5. A secondary brain injury occurred after the craniocerebral injury.
6. Those who need craniotomy or extraventricular drainage.
7. Combining with other serious large organ damage or serious complications may affect the test Life.
8. Patients with active epilepsy who had seizures within 1 year.
9. Patients with severe liver and kidney disease.
10. Complicated with severe heart disease, lung disease, blood and hematopoietic diseases, gastrointestinal disease, serious or progressive disease.
11. Past or present with a malignant tumor
12. Combining neurological and mental disorders that make it impossible or unwilling to cooperate.
13. Women who are pregnant, breastfeeding or have a recent birth plan.
14. Researchers do not consider it appropriate to participate in the clinical trial.
15. Those who have participated in other clinical trials and used test drugs 3 months before the trial.

Where this trial is running

Tianjing, Tianjing

• General Hospital of Tianjin Medical University — Tianjing, Tianjing, China (Recruiting)

Study contacts

• Study coordinator: Tie Xu, Master

Conditions Craniocerebral Injury; L-oxiracetam; Cognitive Impairment