Study on Clinical Effectiveness of L-Oxiracetam Injection

February 14, 2024 updated by: Nanjing Yoko Biomedical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
591

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Tianjing
      • Tianjing, Tianjing, China
        • Recruiting
        • General Hospital of Tianjin Medical University
        • Contact:
          • Rongcai Jiang, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: L-oxiracetam
Drug: Test group: L-oxiracetam Injection
L-oxiracetam injection, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.
Active Comparator: Oxiracetam
Drug: Control group: Oxiracetam Injection
Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Oxiracetam injection, 6 vials, once a day, IV.
Placebo Comparator: Plaecbo
Drug: Placebo group: Placebo Injection
Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Yoko Biomedical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NJYK-L-ORCT-III

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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