Status:
COMPLETED
Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Lead Sponsor:
China Spinal Cord Injury Network
Collaborating Sponsors:
China Rehabilitation Research Center
Buddhist Tzu Chi General Hospital
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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, whil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00750061
Start Date
August 1 2008
End Date
December 1 2010
Last Update
May 4 2015
Active Locations (2)
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1
China Rehabilitation and Research Center
Beijing, China
2
Buddhist Tzu Chi General Hospital, Taichung Branch
Taichung, Taiwan