Clinical trial NCT00750061: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Lead sponsor: China Spinal Cord Injury Network
Sponsor class: NETWORK
Collaborators: name: China Rehabilitation Research Center
name: Buddhist Tzu Chi General Hospital
First posted: 2008-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes of Neurological Scores for Baseline
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Rehabilitation and Research Center
city: Taichung
country: Taiwan
facility: Buddhist Tzu Chi General Hospital, Taichung Branch
Study officials:
affiliation: China Rehabilitation and Research Center
name: Mingliang Yang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Buddhist Tzu Chi General Hospita, Taichung Branch
name: Tzu-Yung Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.