Study on Clinical Effectiveness of L-Oxiracetam Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

591 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease

NCT04643327

Parkinson Disease Mild Cognitive Impairment Memory Impairment

RECRUITING PHASE2

Treating Hyperexcitability in AD With Levetiracetam

NCT03875638

Alzheimer Dementia Alzheimer Disease Dementia of Alzheimer Type +1 more

RECRUITING PHASE2

Levetiracetam in Central Pain in Multiple Sclerosis(MS)

NCT00423527

Multiple Sclerosis

COMPLETED PHASE4

Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

NCT06866691

Traumatic Brain Injury

RECRUITING PHASE4

An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures

NCT01407523

Epilepsy Partial Onset Seizures

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Craniocerebral Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxiracetam

Group Type ACTIVE_COMPARATOR

Control group: Oxiracetam Injection

Intervention Type DRUG

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

Plaecbo

Group Type PLACEBO_COMPARATOR

Placebo group: Placebo Injection

Intervention Type DRUG

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

L-oxiracetam

Group Type ACTIVE_COMPARATOR

Test group: L-oxiracetam Injection

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Test group: L-oxiracetam Injection

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

Intervention Type DRUG

Control group: Oxiracetam Injection

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No