Craniocerebral InjuryPhase 3NCT04205565
Study on Clinical Effectiveness of L-Oxiracetam Injection
A Phase 3 study testing Test group: L-oxiracetam Injection in people with Craniocerebral Injury, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Craniocerebral Injury
- What is being tested?
- Test group: L-oxiracetam Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 591 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2019to 31 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Tianjin Medical University
Tianjing, Tianjing
Rongcai Jiang, doctor
About this study
Official title: 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.
- Conditions
- Craniocerebral Injury
- Being tested
- Test group: L-oxiracetam Injection, Control group: Oxiracetam Injection, Placebo group: Placebo Injection
- Keywords
- L-oxiracetam, Cognitive Impairment, Craniocerebral Injury
- Medical subject headings
- Craniocerebral Trauma, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test group: L-oxiracetam InjectionDrug
L-oxiracetam injection, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.
Control group: Oxiracetam InjectionDrug
Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Oxiracetam injection, 6 vials, once a day, IV.
Placebo group: Placebo InjectionDrug
Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.
| Study group | Role | What they receive |
|---|---|---|
| L-oxiracetam | Active comparator | Not described Receives: Drug: Test group: L-oxiracetam Injection |
| Oxiracetam | Active comparator | Not described Receives: Drug: Control group: Oxiracetam Injection |
| Plaecbo | Placebo comparator | Not described Receives: Drug: Placebo group: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start30 Sep 2019
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Craniocerebral InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 591 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205565
- Sponsor's protocol ID
- NJYK-L-ORCT-III
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41381424Liu 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.
PubMed 38975302
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04205565
- Acronym / sponsor ID
- NJYK-L-ORCT-III
- Conditions
- Craniocerebral Injury
- Keywords
- L-oxiracetam, Cognitive Impairment, Craniocerebral Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 591 participants (estimated)
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test group: L-oxiracetam InjectionL-oxiracetam injection, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV. | Drug | L-oxiracetam |
| Control group: Oxiracetam InjectionPlacebo injection of l-oxiracetam, 4 vials, once a day, IV. Oxiracetam injection, 6 vials, once a day, IV. | Drug | Oxiracetam |
| Placebo group: Placebo InjectionPlacebo injection of l-oxiracetam, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV. | Drug | Plaecbo |
Primary outcome
The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 41381424Liu 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.
- Derived from this study: PubMed 38975302Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test group: L-oxiracetam Injection in people with Craniocerebral Injury, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tie Xu, Master (86-18036618680, xutie@yoko-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of Loewenstein Occupational Therapy Cognitive Assessment (LOCTA) scores between baseline and 3 months after administration of drugs. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04205565, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.