Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries - Full Text View

Sponsor:	China Spinal Cord Injury Network
Collaborators:	China Rehabilitation Research Center Buddhist Tzu Chi General Hospital
Information provided by (Responsible Party):	China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:	NCT00750061

Purpose

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.

Condition	Intervention	Phase
Spinal Cord Injury	Drug: Lithium Carbonate Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Lithium carbonate Lithium citrate

U.S. FDA Resources

Further study details as provided by China Spinal Cord Injury Network:

Primary Outcome Measures:

The changes in the neurological scoring: means of changed motor scores; means of changed sensory scores (light touch and pinprick); and ASIA Impairment Scale grading change. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The changes in the following parameters:Functional Independence Measure; Visual Analog Scale- pain; Modified Ashworth Scale - spasticity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	57
Study Start Date:	August 2008
Study Completion Date:	December 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 2 Placebo	Drug: Placebo Matching placebo
Experimental: 1 Lithium Carbonate	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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750061

Locations

China
China Rehabilitation and Research Center
Beijing, China
Taiwan
Buddhist Tzu Chi General Hospital, Taichung Branch
Taichung, Taiwan

Sponsors and Collaborators

China Spinal Cord Injury Network

China Rehabilitation Research Center

Buddhist Tzu Chi General Hospital

Investigators

Principal Investigator:	Mingliang Yang, MD, Ph.D	China Rehabilitation and Research Center
Principal Investigator:	Tzu-Yung Chen, MD	Buddhist Tzu Chi General Hospita, Taichung Branch

More Information

Publications:

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. 2011 Nov 22; [Epub ahead of print]

Responsible Party:	China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:	NCT00750061 History of Changes
Other Study ID Numbers:	CN102A
Study First Received:	August 30, 2008
Last Updated:	December 1, 2011
Health Authority:	China: Ethics Committee Taiwan: Institutional Review Board

Keywords provided by China Spinal Cord Injury Network:

Spinal Cord Injury

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Lithium Carbonate
Lithium
Antidepressive Agents
Psychotropic Drugs

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on May 23, 2012