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

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ClinicalTrials.gov Identifier: NCT00750061
Recruitment Status : Completed
First Posted : September 10, 2008
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Sponsor:
Collaborators:
China Rehabilitation Research Center
Buddhist Tzu Chi General Hospital
Information provided by (Responsible Party):
China Spinal Cord Injury Network

Study Description
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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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Lithium Carbonate Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablet
 Drug: Placebo
Matching placebo
Experimental: Lithium carbonate
Lithium Carbonate tablet, 250mg
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes of Neurological Scores for Baseline [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain [ Time Frame: 6 months ]
    Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 ~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 ~ 100, the less the better)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750061


Locations
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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
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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
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Publications of Results:

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Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT00750061    
Other Study ID Numbers: CN102A
First Posted: September 10, 2008    Key Record Dates
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015
Last Verified: April 2015
Keywords provided by China Spinal Cord Injury Network:
Spinal Cord Injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Lithium Carbonate
Antidepressive Agents
 Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs