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

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 II

MedlinePlus related topics:

Spinal Cord Injuries

ChemIDplus related topics:

Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial

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 ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Placebo	Drug: Placebo Matching placebo
1: Experimental 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	Recruiting
	Beijing, China
	Contact: Mingliang Yang, MD, Ph.D. 86-10-67563322 ext 4201
	Principal Investigator: Mingliang Yang, MD, Ph.D.

Sponsors and Collaborators

China Spinal Cord Injury Network

Investigators


Principal Investigator:	Mingliang Yang, MD, Ph.D	China Rehabilitation and Research Center

More Information

Responsible Party:	China Spinal Cord Injur Network ( Chief Executive Officer )
Study ID Numbers:	CN102A
First Received:	August 30, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750061
Health Authority:	China: Ethics Committee

Keywords provided by China Spinal Cord Injury Network:

Spinal Cord Injury

Study placed in the following topic categories:

Spinal Cord Injuries

Spinal Cord Diseases

Wounds and Injuries

Lithium Carbonate

Disorders of Environmental Origin

Central Nervous System Diseases

Trauma, Nervous System

Lithium

Additional relevant MeSH terms:

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Antimanic Agents

Antipsychotic Agents

Pharmacologic Actions

Therapeutic Uses

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	China Spinal Cord Injury Network
Information provided by:	China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:	NCT00750061