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

• 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: China Spinal Cord Injury Network
• 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: August 30, 2008
• First Posted Date: September 10, 2008
• Results First Submitted Date: January 6, 2015
• Results First Posted Date: May 4, 2015
• Last Update Posted Date: May 4, 2015
• Study Start Date: August 2008
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Spinal Cord Injury

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 9, 2008): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, Taiwan

Administrative Information

• NCT Number: NCT00750061
• Other Study ID Numbers: CN102A
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: China Spinal Cord Injury Network
• Study Sponsor: China Spinal Cord Injury Network

Collaborators

• China Rehabilitation Research Center
• Buddhist Tzu Chi General Hospital

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

• PRS Account: China Spinal Cord Injury Network
• Verification Date: April 2015