NCT04205565

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 591 (estimated)
• Sponsor: Nanjing Yoko Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-09-30
• Primary completion: 2024-08-30
• Completion: 2024-10-31
• First posted: 2019-12-19
• Last updated: 2024-02-15

Locations

1 site across 1 country: China