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

NCT00750061 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-04

Study results available
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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

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

Sponsors & Collaborators

  • China Rehabilitation Research Center

    collaborator OTHER_GOV

  • Buddhist Tzu Chi General Hospital

    collaborator OTHER

  • China Spinal Cord Injury Network

    lead NETWORK

Principal Investigators

  • Mingliang Yang, MD, Ph.D · China Rehabilitation and Research Center

  • Tzu-Yung Chen, MD · Buddhist Tzu Chi General Hospita, Taichung Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-05-31
Completion
2010-12-31

Countries

  • China
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT00750061 on ClinicalTrials.gov