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Study on Clinical Effectiveness of L-Oxiracetam Injection

Primary Purpose

Craniocerebral Injury

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

High dose group: L-oxiracetam Injection

Low dose group: L-oxiracetam Injection

Control group: Oxiracetam Injection

Placebo group: Placebo Injection

About this trial

This is an interventional treatment trial for Craniocerebral Injury focused on measuring L-oxiracetam, Cognitive Impairment, Craniocerebral Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

General Hospital of Tianjin Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

L-oxiracetam

Oxiracetam

Plaecbo

Arm Description

Outcomes

Primary Outcome Measures

The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs.

Secondary Outcome Measures

Full Information

NCT ID

NCT04205565

First Posted

December 18, 2019

Last Updated

March 19, 2021

Sponsor

Nanjing Yoko Biomedical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04205565

Brief Title

Study on Clinical Effectiveness of L-Oxiracetam Injection

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 8, 2017 (Actual)

Primary Completion Date

January 3, 2020 (Actual)

Study Completion Date

January 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanjing Yoko Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Craniocerebral Injury

Keywords

L-oxiracetam, Cognitive Impairment, Craniocerebral Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

L-oxiracetam

Arm Type

Active Comparator

Arm Title

Oxiracetam

Arm Type

Active Comparator

Arm Title

Plaecbo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

High dose group: L-oxiracetam Injection

Intervention Description

L-oxiracetam injection, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.

Intervention Type

Drug

Intervention Name(s)

Low dose group: L-oxiracetam Injection

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Control group: Oxiracetam Injection

Intervention Description

Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Oxiracetam injection, 6 vials, once a day, IV.

Intervention Type

Drug

Intervention Name(s)

Placebo group: Placebo Injection

Intervention Description

Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.

Primary Outcome Measure Information:

Title

The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

General Hospital of Tianjin Medical University

City

Tianjing

State/Province

Tianjing

Country

China

12. IPD Sharing Statement

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Study on Clinical Effectiveness of L-Oxiracetam Injection

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