Study on Clinical Effectiveness of L-Oxiracetam Injection

NCT04205565 | Recruiting Phase 3

• 1 other identifier: NJYK-L-ORCT-III
• Study Type: interventional
• Target: 591
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Craniocerebral Injury

Keywords

L-oxiracetam; Cognitive Impairment; Craniocerebral Injury

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (3)

L-oxiracetam

ACTIVE COMPARATOR

Drug: Test group: L-oxiracetam Injection

Oxiracetam

ACTIVE COMPARATOR

Drug: Control group: Oxiracetam Injection

Plaecbo

PLACEBO COMPARATOR

Drug: Placebo group: Placebo Injection

Interventions

Test group: L-oxiracetam Injection DRUG

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

L-oxiracetam

Control group: Oxiracetam Injection DRUG

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

Oxiracetam

Placebo group: Placebo Injection DRUG

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

Plaecbo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Yoko Biomedical Co., Ltd.: lead

Study Sites (1)

General Hospital of Tianjin Medical University

Tianjing, Tianjing, China

RECRUITING

Related Publications (2)

• Liu T, Wang J, Zhao Z, Jiang W, Zhang M, Yu Y, Liu Y, Liu M, Chen L, Zhang H, Hong Y, Li B, Yu R, Ji H, Mi L, Zhao B, Lv C, Liu C, Zhang J, Jiang R; LOCATE Trial Investigators. Efficacy and safety of L-oxiracetam on cognitive function in patients with traumatic brain injury: a multicentre, randomised, double-blind, phase 3 clinical trial. Signal Transduct Target Ther. 2025 Dec 12;10(1):401. doi: 10.1038/s41392-025-02492-5.

  PMID: 41381424 DERIVED

• Liu T, Liu M, Nie M, Zhao Z, Liu X, Qian Y, Yu Y, Sha Z, Wu C, Yuan J, Jiang W, Lv C, Mi L, Tian Y, Zhang J, Jiang R. Effect of l-oxiracetam and oxiracetam on memory and cognitive impairment in mild-to-moderate traumatic brain injury patients: Study protocol for a randomized controlled trial. Aging Med (Milton). 2024 Jun 14;7(3):341-349. doi: 10.1002/agm2.12335. eCollection 2024 Jun.

  PMID: 38975302 DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Tie Xu, Master

CONTACT

86-18036618680; xutie@yoko-bio.com

Huiwen Jiao, Master

CONTACT

86-15850633389; jiaohuiwen@yoko-bio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 19, 2019
• Study Start: September 30, 2019
• Primary Completion: August 30, 2024
• Study Completion: October 31, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

CN (1)