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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750061
• Other study ID #: CN102A
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2008
• Last updated: April 28, 2015
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2015
• Source: China Spinal Cord Injury Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeTaiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• 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.
• Placebo
Matching placebo

Locations

Country	Name	City	State
China	China Rehabilitation and Research Center	Beijing
Taiwan	Buddhist Tzu Chi General Hospital, Taichung Branch	Taichung

Sponsors (3)

Lead Sponsor	Collaborator
China Spinal Cord Injury Network	Buddhist Tzu Chi General Hospital, China Rehabilitation Research Center

Countries where clinical trial is conducted

China,  Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	Yes
Secondary	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)	6 months	Yes