Study on Clinical Effectiveness of L-Oxiracetam Injection

• Sponsor: Nanjing Yoko Biomedical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04205565
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 3
• Actual Duration (Months): 25.8
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

A randomized, double-blind, positive drug/placebo parallel controlled, multicenter, phase II exploratory clinical trial of L-oxiracetam injection to improve memory and cognitive Impairment in patients with craniocerebral injury.

Condition or Disease	Intervention/Treatment	Phase
Craniocerebral Injury	Drug: High dose group: L-oxiracetam Injection; Drug: Low dose group: L-oxiracetam Injection; Drug: Control group: Oxiracetam Injection; Drug: Placebo group: Placebo Injection	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Positive Drug/Placebo Parallel Controlled, Multicenter, Phase II Exploratory Clinical Trial of L-oxiracetam Injection to Improve Memory and Cognitive Impairment in Patients With Craniocerebral Injury
• Actual Study Start Date: Nov 8, 2017
• Actual Primary Completion Date: Jan 3, 2020
• Actual Study Completion Date: Jan 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: L-oxiracetam	Drug: High dose group: L-oxiracetam Injection; L-oxiracetam injection, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.; Drug: Low dose group: L-oxiracetam Injection; L-oxiracetam injection, 3 vials, once a day, IV. Placebo injection of l-oxiracetam, 1 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Tianjin Medical University	Tianjing	Tianjing	China

Sponsors and Collaborators

• Nanjing Yoko Biomedical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nanjing Yoko Biomedical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04205565
• Other Study ID Numbers: PHMS201614F
• First Posted: Dec 19, 2019
• Last Update Posted: Mar 22, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nanjing Yoko Biomedical Co., Ltd.: L-oxiracetam; Cognitive Impairment; Craniocerebral Injury
• Additional relevant MeSH terms: Craniocerebral Trauma; Oxiracetam

Study Results

No Results Posted as of Mar 22, 2021