Study on Clinical Effectiveness of L-Oxiracetam Injection

Study Overview
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Brief Summary
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A randomized, double-blind, positive drug/placebo parallel controlled, multicenter, phase II exploratory clinical trial of L-oxiracetam injection to improve memory and cognitive Impairment in patients with craniocerebral injury.

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

Conditions
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Craniocerebral Injury

Intervention / Treatment
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* Drug: High dose group: L-oxiracetam Injection
* Drug: Low dose group: L-oxiracetam Injection
* Drug: Control group: Oxiracetam Injection
* Drug: Placebo group: Placebo Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years old (including upper and lower limits), male or female 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. Within 72 hours after head injury, patients with stable and mentally handicapped mental state examination (MMSE) scores are lower than normal. The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form. Exclusion Criteria: People who are known or suspected to be allergic to the test drug and its ingredients. After the injury, drugs that improve cognitive function such as the prohibited drugs listed in the protocol have been used. With a history of severe traumatic brain injury, a history of cerebrovascular accidents, and structural craniocerebral lesions. With diseases such as speech and hearing impairment that cannot cooperate with the completion of cognitive function assessment. A secondary brain injury occurred after the craniocerebral injury. Those who need craniotomy or extraventricular drainage. Combining with other serious large organ damage or serious complications may affect the test Life. Patients with active epilepsy who had seizures within 1 year. Patients with severe liver and kidney disease. Complicated with severe heart disease, lung disease, blood and hematopoietic diseases, gastrointestinal disease, serious or progressive disease. Past or present with a malignant tumor Combining neurological and mental disorders that make it impossible or unwilling to cooperate. Women who are pregnant, breastfeeding or have a recent birth plan. Researchers do not consider it appropriate to participate in the clinical trial. Those who have participated in other clinical trials and used test drugs 3 months before the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-oxiracetam<br> | Drug: High dose group: L-oxiracetam Injection<br>* L-oxiracetam injection, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.<br>Drug: Low dose group: L-oxiracetam Injection<br>* L-oxiracetam injection, 3 vials, once a day, IV. Placebo injection of l-oxiracetam, 1 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.<br>|
| Active Comparator: Oxiracetam<br> | Drug: Control group: Oxiracetam Injection<br>* Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Oxiracetam injection, 6 vials, once a day, IV.<br>|
| Placebo Comparator: Plaecbo<br> | Drug: Placebo group: Placebo Injection<br>* Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L-oxiracetam, Cognitive Impairment, Craniocerebral Injury