Trial Outcomes & Findings for Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries (NCT NCT00750061)
NCT ID: NCT00750061
Last Updated: 2015-05-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
6 months
Results posted on
2015-05-04
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Matching placebo
|
Lithium Carbonate Tablet
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 Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Matching placebo
|
Lithium Carbonate Tablet
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 Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Placebo
Placebo: Matching placebo
|
Lithium Carbonate
n=20 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.05 Year
STANDARD_DEVIATION 10.092 • n=5 Participants
|
41.4 Year
STANDARD_DEVIATION 6.785 • n=7 Participants
|
39.624 Year
STANDARD_DEVIATION 8.617 • n=5 Participants
|
|
Age, Customized
18-30 years-old
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age, Customized
31-40 years-old
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Age, Customized
41-50 years-old
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Age, Customized
51-60 years-old
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Full Analysis Set
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.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo
Placebo: Matching placebo
|
Lithium Carbonate
n=20 Participants
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.
|
|---|---|---|
|
Changes of Neurological Scores for Baseline
change light touch score (wk6-d0)
|
-0.158 units on a scale
Standard Deviation 0.688
|
0 units on a scale
Standard Deviation 0
|
|
Changes of Neurological Scores for Baseline
change light touch score (m6-d0)
|
2.208 units on a scale
Standard Deviation 7.141
|
-0.766 units on a scale
Standard Deviation 6.014
|
|
Changes of Neurological Scores for Baseline
change pin-prick score (wk6-d0)
|
0.053 units on a scale
Standard Deviation 0.229
|
0.053 units on a scale
Standard Deviation 0.229
|
|
Changes of Neurological Scores for Baseline
change pin-prick score (m6-d0)
|
1.906 units on a scale
Standard Deviation 6.775
|
-0.982 units on a scale
Standard Deviation 6.498
|
|
Changes of Neurological Scores for Baseline
change motor score (wk6-d0)
|
-1 units on a scale
Standard Deviation 4.607
|
0 units on a scale
Standard Deviation 0
|
|
Changes of Neurological Scores for Baseline
change motor score (m6-d0)
|
0.844 units on a scale
Standard Deviation 6.471
|
1.316 units on a scale
Standard Deviation 2.657
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full Analysis Set
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)
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo
Placebo: Matching placebo
|
Lithium Carbonate
n=20 Participants
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.
|
|---|---|---|
|
Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
change in VAS (Wk6 - D0)
|
1.0 units on a scale
Standard Deviation 4.0
|
-9.3 units on a scale
Standard Deviation 16.6
|
|
Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
change in FIM (Wk6 - D0)
|
0.2 units on a scale
Standard Deviation 0.4
|
-0.3 units on a scale
Standard Deviation 1.6
|
|
Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
change in FIM (M6 - D0)
|
3.5 units on a scale
Standard Deviation 7.3
|
0.04 units on a scale
Standard Deviation 5.4
|
|
Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain
change in VAS (M6 - D0)
|
-0.9 units on a scale
Standard Deviation 17.1
|
-9.3 units on a scale
Standard Deviation 15.3
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Lithium Carbonate Tablet
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo: Matching placebo
|
Lithium Carbonate Tablet
n=20 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Dry eye
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 6 months
|
25.0%
5/20 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • 6 months
|
15.0%
3/20 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • 6 months
|
20.0%
4/20 • Number of events 4 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • 6 months
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal disease
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
General disorders
Asthenia
|
10.0%
2/20 • Number of events 2 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
General disorders
Thirst
|
5.0%
1/20 • Number of events 1 • 6 months
|
20.0%
4/20 • Number of events 4 • 6 months
|
|
General disorders
Pain
|
20.0%
4/20 • Number of events 4 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
General disorders
Oedema
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Infections and infestations
Urogenital infection bacterial
|
10.0%
2/20 • Number of events 2 • 6 months
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • 6 months
|
15.0%
3/20 • Number of events 3 • 6 months
|
|
Investigations
Urine output
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Investigations
Blood creatinine increased
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Investigations
Urine sediment present
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Investigations
Aspartate aminotransferase increase
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Investigations
Glucose urine present
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/20 • 6 months
|
15.0%
3/20 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.0%
3/20 • Number of events 3 • 6 months
|
15.0%
3/20 • Number of events 3 • 6 months
|
|
Nervous system disorders
Poor quality sleep
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • 6 months
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • 6 months
|
25.0%
5/20 • Number of events 5 • 6 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • 6 months
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • 6 months
|
15.0%
3/20 • Number of events 4 • 6 months
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Self injurious behaviour
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Polyuria
|
5.0%
1/20 • Number of events 1 • 6 months
|
10.0%
2/20 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Chromaturina
|
5.0%
1/20 • Number of events 1 • 6 months
|
0.00%
0/20 • 6 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place