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

April 28, 2015 updated by: China Spinal Cord Injury Network

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • China Rehabilitation and Research Center
      • Taichung, Taiwan
        • Buddhist Tzu Chi General Hospital, Taichung Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects of either gender and 18-60 years of age;
  • Subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer);
  • Subjects with ASIA - classification of A, B, or C for at least 6 months unchanged;
  • Spinal cord injury vertebral level should be between C4 and T10;
  • Subjects must be able to read, understand, and complete the VAS;
  • Subjects who have voluntarily signed and dated an informed consent form, approved by an IRB/IEC, prior to any study specific procedures.

Exclusion Criteria:

  • A history of hypersensitivity or other adverse reaction to lithium;
  • Significant renal, cardiovascular, hepatic and psychiatric disease;
  • Significant medical diseases or infection;
  • Addison's disease;
  • Debilitation or dehydration;
  • Recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines;
  • A history of alcohol abuse or drug abuse;
  • Pregnant or lactating women;
  • Female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study;
  • Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study;
  • Subjects who have taken lithium for manic depression or other psychiatric conditions,and finally;
  • Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo tablet
Matching placebo
Experimental: Lithium carbonate
Lithium Carbonate tablet, 250mg

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Neurological Scores for Baseline
Time Frame: 6 months
Changes of Motor Scores (0 ~ 100), Pin Prick Scores (0 ~ 112) and Light Touch Scores (0 ~ 112) from Baseline to Week 6 and Month 6. The higher the changes the better the functional improvement.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
Time Frame: 6 months
Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 ~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 ~ 100, the less the better)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mingliang Yang, MD, Ph.D, China Rehabilitation and Research Center
  • Principal Investigator: Tzu-Yung Chen, MD, Buddhist Tzu Chi General Hospita, Taichung Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 30, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (Estimate)

September 10, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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