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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lithium Carbonate
Placebo
Sponsored by
China Spinal Cord Injury Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lithium carbonate

Arm Description

Placebo tablet

Lithium Carbonate tablet, 250mg

Outcomes

Primary Outcome Measures

Changes of Neurological Scores for Baseline
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.

Secondary Outcome Measures

Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
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)

Full Information

First Posted
August 30, 2008
Last Updated
April 28, 2015
Sponsor
China Spinal Cord Injury Network
Collaborators
China Rehabilitation Research Center, Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00750061
Brief Title
Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Official Title
Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Spinal Cord Injury Network
Collaborators
China Rehabilitation Research Center, Buddhist Tzu Chi General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Arm Title
Lithium carbonate
Arm Type
Experimental
Arm Description
Lithium Carbonate tablet, 250mg
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Changes of Neurological Scores for Baseline
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingliang Yang, MD, Ph.D
Organizational Affiliation
China Rehabilitation and Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tzu-Yung Chen, MD
Organizational Affiliation
Buddhist Tzu Chi General Hospita, Taichung Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Rehabilitation and Research Center
City
Beijing
Country
China
Facility Name
Buddhist Tzu Chi General Hospital, Taichung Branch
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22105463
Citation
Yang ML, Li JJ, So KF, Chen JY, Cheng WS, Wu J, Wang ZM, Gao F, Young W. Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial. Spinal Cord. 2012 Feb;50(2):141-6. doi: 10.1038/sc.2011.126. Epub 2011 Nov 22.
Results Reference
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Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries

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