Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| China Rehabilitation Research Center | OTHER_GOV |
| Buddhist Tzu Chi General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Lithium carbonate | Experimental | Lithium Carbonate tablet, 250mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Neurological Scores for Baseline | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | 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) | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mingliang Yang, MD, Ph.D | China Rehabilitation and Research Center | Principal Investigator |
| Tzu-Yung Chen, MD | Buddhist Tzu Chi General Hospita, Taichung Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Rehabilitation and Research Center | Beijing | China | ||||
| Buddhist Tzu Chi General Hospital, Taichung Branch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22105463 | Result | Yang ML, Li JJ, So KF, Chen JY, Cheng WS, Wu J, Wang ZM, Gao F, Young W. Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial. Spinal Cord. 2012 Feb;50(2):141-6. doi: 10.1038/sc.2011.126. Epub 2011 Nov 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Matching placebo |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo: Matching placebo |
| BG001 | Lithium Carbonate | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes of Neurological Scores for Baseline | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Matching placebo |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wendy Cheng | China Spinal Cord Injury Network | +852 28660829 | wendycheng@chinasci.net |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Matching placebo |
|
| Taichung |
| Taiwan |
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain | 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) | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| 0 |
| 20 |
| 14 |
| 20 |
| EG001 | 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. | 0 | 20 | 16 | 20 |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Gastrooesophageal disease | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Urogenital infection bacterial | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Urine output | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Blood glucose abnormal | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Urine sediment present | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Aspartate aminotransferase increase | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Self injurious behaviour | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Chromaturina | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
|
Not provided
Not provided
| D014947 | Wounds and Injuries |
| D017554 |
| Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| change in VAS (Wk6 - D0) |
|
| change in VAS (M6 - D0) |
|
| 0.168 |
| 2-Sided |
| No |
| Superiority or Other |
| VAS change (Wk6 - D0) | Wilcoxon (Mann-Whitney) | 0.013 | 2-Sided | No | Superiority or Other |
| VAS change (M6 - D0) | Wilcoxon (Mann-Whitney) | 0.137 | 2-Sided | No | Superiority or Other |