NCT04205565Unknown3 期
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
Nanjing Yoko Biomedical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 591 人开始时间: 2019年9月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 591
- 试验地点
- 1
- 主要终点
- The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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