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

NCT ID: NCT00750061

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-12-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Lithium carbonate

Lithium Carbonate tablet, 250mg

Group Type: EXPERIMENTAL

Lithium Carbonate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Rehabilitation Research Center

OTHER_GOV

Sponsor Role: collaborator

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: collaborator

China Spinal Cord Injury Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingliang Yang, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

China Rehabilitation and Research Center

Tzu-Yung Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospita, Taichung Branch

Locations

China Rehabilitation and Research Center

Beijing, , China

Buddhist Tzu Chi General Hospital, Taichung Branch

Taichung, , Taiwan

Countries

China; Taiwan

References

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.

Reference Type: RESULT

PMID: 22105463 (View on PubMed)

Other Identifiers

CN102A

Identifier Type: -

Identifier Source: org_study_id