Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CN102a
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00750061
Recruitment Status : Completed
First Posted : September 10, 2008
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Sponsor:
Collaborators:
China Rehabilitation Research Center
Buddhist Tzu Chi General Hospital
Information provided by (Responsible Party):
China Spinal Cord Injury Network

Tracking Information
First Submitted Date  ICMJE August 30, 2008
First Posted Date  ICMJE September 10, 2008
Results First Submitted Date  ICMJE January 6, 2015
Results First Posted Date  ICMJE May 4, 2015
Last Update Posted Date May 4, 2015
Study Start Date  ICMJE August 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2008)
The changes in the neurological scoring: means of changed motor scores; means of changed sensory scores (light touch and pinprick); and ASIA Impairment Scale grading change. [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00750061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2008)
The changes in the following parameters:Functional Independence Measure; Visual Analog Scale- pain; Modified Ashworth Scale - spasticity [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Official Title  ICMJE Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo tablet
    Intervention: Drug: Placebo
  • Experimental: Lithium carbonate
    Lithium Carbonate tablet, 250mg
    Intervention: Drug: Lithium Carbonate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00750061
Other Study ID Numbers  ICMJE CN102A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Spinal Cord Injury Network
Study Sponsor  ICMJE China Spinal Cord Injury Network
Collaborators  ICMJE
  • China Rehabilitation Research Center
  • Buddhist Tzu Chi General Hospital
Investigators  ICMJE
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
PRS Account China Spinal Cord Injury Network
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP