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

Information source: China Spinal Cord Injury Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinal Cord Injury

Intervention: Lithium Carbonate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: China Spinal Cord Injury Network

Official(s) and/or principal investigator(s):
Mingliang Yang, MD, Ph.D, Principal Investigator, Affiliation: China Rehabilitation and Research Center
Tzu-Yung Chen, MD, Principal Investigator, Affiliation: Buddhist Tzu Chi General Hospita, Taichung Branch

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Changes of Neurological Scores for Baseline

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

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

China Rehabilitation and Research Center, Beijing, China

Buddhist Tzu Chi General Hospital, Taichung Branch, Taichung, Taiwan

Additional Information

Starting date: August 2008
Last updated: April 28, 2015

Page last updated: August 23, 2015

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