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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 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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Lithium Carbonate Tablet
Hide 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
Arm/Group Title Placebo Lithium Carbonate Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 20 participants 20 participants 40 participants
38.05  (10.092) 41.4  (6.785) 39.624  (8.617)
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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
1
   5.0%
1
   5.0%
2
   5.0%
Male
19
  95.0%
19
  95.0%
38
  95.0%
1.Primary Outcome
Title Changes of Neurological Scores for Baseline
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo Lithium Carbonate
Hide 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.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
change light touch score (wk6-d0) -0.158  (0.688) 0  (0)
change light touch score (m6-d0) 2.208  (7.141) -0.766  (6.014)
change pin-prick score (wk6-d0) 0.053  (0.229) 0.053  (0.229)
change pin-prick score (m6-d0) 1.906  (6.775) -0.982  (6.498)
change motor score (wk6-d0) -1  (4.607) 0  (0)
change motor score (m6-d0) 0.844  (6.471) 1.316  (2.657)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments change light touch score (wk6-d0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.343
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments change light touch score (m6-d0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments change pin-prick score (wk6-d0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments change pin-prick score (m6-d0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments change motor score (wk6-d0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments change motor score (m6-d0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.582
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
Hide Description 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)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo Lithium Carbonate
Hide 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.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
change in FIM (Wk6 - D0) 0.2  (0.4) -0.3  (1.6)
change in FIM (M6 - D0) 3.5  (7.3) 0.04  (5.4)
change in VAS (Wk6 - D0) 1.0  (4.0) -9.3  (16.6)
change in VAS (M6 - D0) -0.9  (17.1) -9.3  (15.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments FIM change (Wk6 - D0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments FIM change (M6 - D0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments VAS change (Wk6 - D0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Lithium Carbonate
Comments VAS change (M6 - D0)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lithium Carbonate Tablet
Hide 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.

All-Cause Mortality
Placebo Lithium Carbonate Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lithium Carbonate Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Lithium Carbonate Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/20 (70.00%)      16/20 (80.00%)    
Eye disorders     
Dry eye * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders     
Nausea * 1  1/20 (5.00%)  1 5/20 (25.00%)  5
Abdominal discomfort * 1  0/20 (0.00%)  0 3/20 (15.00%)  3
Diarrhoea * 1  1/20 (5.00%)  1 4/20 (20.00%)  4
Vomiting * 1  0/20 (0.00%)  0 2/20 (10.00%)  2
Salivary hypersecretion * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Toothache * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Gingival swelling * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Gastrooesophageal disease * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
General disorders     
Asthenia * 1  2/20 (10.00%)  2 1/20 (5.00%)  1
Thirst * 1  1/20 (5.00%)  1 4/20 (20.00%)  4
Pain * 1  4/20 (20.00%)  4 1/20 (5.00%)  1
Oedema * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Chest discomfort * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Infections and infestations     
Urogenital infection bacterial * 1  2/20 (10.00%)  2 2/20 (10.00%)  2
Upper respiratory tract infection * 1  1/20 (5.00%)  1 3/20 (15.00%)  3
Investigations     
Urine output * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Blood glucose abnormal * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Blood creatinine increased * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Alanine aminotransferase increased * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Urine sediment present * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Aspartate aminotransferase increase * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Glucose urine present * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Neutrophil count decreased * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Metabolism and nutrition disorders     
Polydipsia * 1  0/20 (0.00%)  0 3/20 (15.00%)  3
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Limb discomfort * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Muscle spasms * 1  3/20 (15.00%)  3 3/20 (15.00%)  3
Nervous system disorders     
Poor quality sleep * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Headache * 1  0/20 (0.00%)  0 2/20 (10.00%)  2
Dizziness * 1  1/20 (5.00%)  1 5/20 (25.00%)  5
Hypoaesthesia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Somnolence * 1  0/20 (0.00%)  0 2/20 (10.00%)  2
Tremor * 1  0/20 (0.00%)  0 3/20 (15.00%)  4
Hypotonia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Psychiatric disorders     
Self injurious behaviour * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Insomnia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders     
Polyuria * 1  1/20 (5.00%)  1 2/20 (10.00%)  2
Chromaturina * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders     
Decubitus ulcer * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Wendy Cheng
Organization: China Spinal Cord Injury Network
Phone: +852 28660829
EMail: wendycheng@chinasci.net
Layout table for additonal information
Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT00750061     History of Changes
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