Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
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| ClinicalTrials.gov Identifier: NCT01855594 |
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Recruitment Status :
Completed
First Posted : May 16, 2013
Last Update Posted : January 28, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuropathic Pain Neuralgia Spinal Cord Injuries | Drug: Lithium Carbonate Drug: Placebo | Phase 2 |
This is a randomized, placebo-controlled, double-blinded trial. Sixty spinal cord injured subjects with neuropathic pain will be randomized into two groups. The subject in the Treatment Group will receive lithium carbonate tablet, while the Control Group will receive placebo tablet. Neither the subjects nor the physicians know which group the subjects are allocated.
Each subject will receive 6 weeks of oral lithium carbonate or placebo. In the Treatment Group, the dose will be adjusted according to the serum lithium level. While in the Control Group, the dose will be adjusted based on the dummy serum level report.
The outcome will be assessed during visits at 1 week, 2 weeks, 6 weeks and 12 weeks, and a phone call follow-up at 24 weeks from the start of the medication. The primary outcome measure is the severity level of pain. The efficacy and safety will be analyzed by comparing the results of the Treatment Group with those of the Control Group
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Double Blind, Randomized Placebo-controlled Clinical Study Evaluating the Efficacy of Lithium Carbonate in the Treatment of Neuropathic Pain of Patients With Spinal Cord Injury |
| Study Start Date : | May 2013 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lithium treatment group
Lithium carbonate, 250mg/tablet. The dose starts with three times a day and one tablet each time for a week. The daily dose will then be adjusted according to serum lithium level and clinical finding. Target serum lithium level is 0.6 - 1.2mmol/L.
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Drug: Lithium Carbonate
250 mg/tablet, 6 weeks course of oral administration |
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Placebo Comparator: Control group
The dose of the placebo will be adjusted according to the dummy serum level report.
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Drug: Placebo
placebo tablet, 6 week course of oral administration |
- Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks [ Time Frame: D0, Wk 1, 2, 6, 12, and 24 ]pain severity level
- Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS) [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
- Change in Short-Form 36 single question [ Time Frame: D0, Wk 1, 2, 6, 12, and 24 ]
- Change in Sleep Interference Assessment score [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
- Change in weekly number of days with pain attack [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
- Change in the Patient Global Impression of Change (PGIC) [ Time Frame: Wk 1, 2, 6, and 12 ]
- Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: D0, Wk 1, 2, 6 and 12 ]
- Change in sensory score, motor score and ASIA impairment (AIS) scale [ Time Frame: D0, Wk 6 and 12 ]
- Change in Modified Ashworth Scale [ Time Frame: D0, Wk 6 and 12 ]
- Magnetic resonance diffusion tensor imaging (optional) [ Time Frame: D0, Wk 6 and 12 ]
- Electrophysiology (optional) [ Time Frame: D0, Wk 6 and 12 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 - 65;
- Diagnosis of traumatic spinal cord injury;
- Clinically diagnosed neuropathic pain;
- Pain severity is at least 4 on a 11-point numeric rating scale at screening;
- Pain present regularly for at least 6 weeks before enrollment;
- Able to understand instructions and provide reliable pain assessments;
- Subjects who are voluntarily signed and dated an Ethics Committee approved informed consent form;
Exclusion Criteria:
- Significant renal, cardiovascular, hepatic, infectious or psychiatric disease;
- Significant brain injury with neurological deficits;
- Debilitation or dehydration;
- Addison's disease;
- Recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines;
- A history of substance or alcohol abuse within past 1 year;
- A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period;
- Current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control;
- Participation in any drug study in the last three months;
- History of oral lithium intake for any reason; or
- any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855594
| China, Shanxi | |
| Xi'an Jiaotong University Second Affiliated Hospital | |
| Xi'an, Shanxi, China | |
| China | |
| China Rehabilitation Research Center | |
| Beijing, China | |
| Principal Investigator: | Xijing He, M.D. | Xi'an Jiaotong University Second Affiliated Hospital | |
| Principal Investigator: | Jianjun Li, M.D. | China Rehabilitaition Research Center |
| Responsible Party: | China Spinal Cord Injury Network |
| ClinicalTrials.gov Identifier: | NCT01855594 |
| Other Study ID Numbers: |
CN302 |
| First Posted: | May 16, 2013 Key Record Dates |
| Last Update Posted: | January 28, 2016 |
| Last Verified: | January 2016 |
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Spinal Cord Injuries Neuralgia Wounds and Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Peripheral Nervous System Diseases Neuromuscular Diseases Pain |
Neurologic Manifestations Lithium Carbonate Antidepressive Agents Psychotropic Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |