NCT00750061

Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries

Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: China Spinal Cord Injury Network · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo. Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment. The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Lithium Carbonate	The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM. The course of medication is 6 weeks.
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-05-01
• Completion: 2010-12-01
• First posted: 2008-09-10
• Last updated: 2015-05-04
• Results posted: 2015-05-04

Locations

2 sites across 2 countries: China, Taiwan