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Study on Clinical Effectiveness of L-Oxiracetam Injection

NCT04205565 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 591

Last updated 2024-02-15

No results posted yet for this study

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

Interventions

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.

DRUG

Control group: Oxiracetam Injection

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

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.

Sponsors & Collaborators

  • Nanjing Yoko Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2024-08-30
Completion
2024-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205565 on ClinicalTrials.gov