Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
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| ClinicalTrials.gov Identifier: NCT00750061 |
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Recruitment Status :
Completed
First Posted : September 10, 2008
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
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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
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Spinal Cord Injury |
| Interventions |
Drug: Lithium Carbonate Drug: Placebo |
| Enrollment | 40 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Placebo | Lithium Carbonate Tablet |
|---|---|---|
 Arm/Group Description |
Placebo: Matching placebo |
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. |
| Period Title: Overall Study | ||
| Started | 20 | 20 |
| Completed | 18 | 18 |
| Not Completed | 2 | 2 |
| Reason Not Completed | ||
| Adverse Event | 2 | 0 |
| Withdrawal by Subject | 0 | 1 |
| Physician Decision | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Placebo | Lithium Carbonate | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Placebo Placebo: Matching placebo |
Lithium Carbonate 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. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 20 | 20 | 40 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Year |
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| Number Analyzed | 20 participants | 20 participants | 40 participants | |
| 38.05 (10.092) | 41.4 (6.785) | 39.624 (8.617) | ||
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 20 participants | 20 participants | 40 participants |
| 18-30 years-old | 4 | 1 | 5 | |
| 31-40 years-old | 9 | 8 | 17 | |
| 41-50 years-old | 4 | 10 | 14 | |
| 51-60 years-old | 3 | 1 | 4 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 20 participants | 20 participants | 40 participants | |
| Female |
1 5.0%
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1 5.0%
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2 5.0%
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| Male |
19 95.0%
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19 95.0%
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38 95.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Dr. Wendy Cheng |
| Organization: | China Spinal Cord Injury Network |
| Phone: | +852 28660829 |
| EMail: | wendycheng@chinasci.net |
| Responsible Party: | China Spinal Cord Injury Network |
| ClinicalTrials.gov Identifier: | NCT00750061 |
| Other Study ID Numbers: |
CN102A |
| First Submitted: | August 30, 2008 |
| First Posted: | September 10, 2008 |
| Results First Submitted: | January 6, 2015 |
| Results First Posted: | May 4, 2015 |
| Last Update Posted: | May 4, 2015 |