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

NCT00750061 | Completed Phase 2 Results DMC

• 1 other identifier: CN102A
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Lithium carbonate

EXPERIMENTAL

Lithium Carbonate tablet, 250mg

Drug: Lithium Carbonate

Interventions

Lithium Carbonate 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.

Lithium carbonate

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Spinal Cord Injury Network: lead
• China Rehabilitation Research Center: collaborator
• Buddhist Tzu Chi General Hospital: collaborator

Study Sites (2)

China Rehabilitation and Research Center

Beijing, China

Location

Buddhist Tzu Chi General Hospital, Taichung Branch

Taichung, Taiwan

Location

Related 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. doi: 10.1038/sc.2011.126. Epub 2011 Nov 22.

  PMID: 22105463 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Results Point of Contact

• Title: Dr. Wendy Cheng
• Organization: China Spinal Cord Injury Network

wendycheng@chinasci.net

+852 28660829

Study Officials

• Mingliang Yang, MD, Ph.D

  China Rehabilitation and Research Center

  PRINCIPAL INVESTIGATOR

• Tzu-Yung Chen, MD

  Buddhist Tzu Chi General Hospita, Taichung Branch

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2008
• First Posted: September 10, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 4, 2015
• Results First Posted: May 4, 2015

Record last verified: 2015-04

Locations

TW (1); CN (1)