Study on Clinical Effectiveness of L-Oxiracetam Injection

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: Recruiting
• Conditions: Craniocerebral Injury
• Intervention / Treatment: Drug: Control group: Oxiracetam Injection; Drug: Placebo group: Placebo Injection; Drug: Test group: L-oxiracetam Injection

• Study Type: Interventional
• Enrollment (Estimated): 591
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tie Xu, Master; Phone Number: 86-18036618680; Email: xutie@yoko-bio.com
• Study Contact Backup: Name: Huiwen Jiao, Master; Phone Number: 86-15850633389; Email: jiaohuiwen@yoko-bio.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Nanjing Yoko Biomedical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Craniocerebral Injury; L-oxiracetam
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma; Psychotropic Drugs; Nootropic Agents; Oxiracetam
• Other Study ID 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