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Completed

NCT Number: NCT00750061

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

China Rehabilitation and Research Center, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Drug

Matching placebo

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

China Spinal Cord Injury Network

Network

Collaborators

  • Buddhist Tzu Chi General Hospital
  • China Rehabilitation Research Center

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2008
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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