Study on Clinical Effectiveness of L-Oxiracetam Injection

Nanjing Yoko Biomedical

Status and phase: Enrolling; Phase 3

Conditions: Craniocerebral Injury

Treatments: Drug: Control group: Oxiracetam Injection; Drug: Placebo group: Placebo Injection; Drug: Test group: L-oxiracetam Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04205565

NJYK-L-ORCT-III

Details and patient eligibility

About

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.

Enrollment: 591 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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591 participants in 3 patient groups, including a placebo group

L-oxiracetam

Active Comparator group

Treatment:

Drug: Test group: L-oxiracetam Injection

Oxiracetam

Active Comparator group

Treatment:

Drug: Control group: Oxiracetam Injection

Plaecbo

Placebo Comparator group

Treatment:

Drug: Placebo group: Placebo Injection