Back to resultsStudy to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
Primary Purpose
Neuropathic Pain, Neuralgia, Spinal Cord Injuries
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lithium Carbonate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
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.
Sites / Locations
- Xi'an Jiaotong University Second Affiliated Hospital
- China Rehabilitation Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lithium treatment group
Control group
Arm Description
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.
The dose of the placebo will be adjusted according to the dummy serum level report.
Outcomes
Primary Outcome Measures
Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks
pain severity level
Secondary Outcome Measures
Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS)
Change in Short-Form 36 single question
Change in Sleep Interference Assessment score
Change in weekly number of days with pain attack
Change in the Patient Global Impression of Change (PGIC)
Change in Patient Health Questionnaire (PHQ-9)
Change in sensory score, motor score and ASIA impairment (AIS) scale
Change in Modified Ashworth Scale
Magnetic resonance diffusion tensor imaging (optional)
Electrophysiology (optional)
Full Information
NCT ID
NCT01855594
First Posted
May 12, 2013
Last Updated
January 26, 2016
Sponsor
China Spinal Cord Injury Network
Collaborators
China Rehabilitation Research Center, Second Affiliated Hospital of Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT01855594
Brief Title
Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Spinal Cord Injury Network
Collaborators
China Rehabilitation Research Center, Second Affiliated Hospital of Xi'an Jiaotong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Neuralgia, Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lithium treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The dose of the placebo will be adjusted according to the dummy serum level report.
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Intervention Description
250 mg/tablet, 6 weeks course of oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablet, 6 week course of oral administration
Primary Outcome Measure Information:
Title
Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks
Description
pain severity level
Time Frame
D0, Wk 1, 2, 6, 12, and 24
Secondary Outcome Measure Information:
Title
Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS)
Time Frame
D0, Wk 1, 2, 6, 12 and 24
Title
Change in Short-Form 36 single question
Time Frame
D0, Wk 1, 2, 6, 12, and 24
Title
Change in Sleep Interference Assessment score
Time Frame
D0, Wk 1, 2, 6, 12 and 24
Title
Change in weekly number of days with pain attack
Time Frame
D0, Wk 1, 2, 6, 12 and 24
Title
Change in the Patient Global Impression of Change (PGIC)
Time Frame
Wk 1, 2, 6, and 12
Title
Change in Patient Health Questionnaire (PHQ-9)
Time Frame
D0, Wk 1, 2, 6 and 12
Title
Change in sensory score, motor score and ASIA impairment (AIS) scale
Time Frame
D0, Wk 6 and 12
Title
Change in Modified Ashworth Scale
Time Frame
D0, Wk 6 and 12
Title
Magnetic resonance diffusion tensor imaging (optional)
Time Frame
D0, Wk 6 and 12
Title
Electrophysiology (optional)
Time Frame
D0, Wk 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xijing He, M.D.
Organizational Affiliation
Xi'an Jiaotong University Second Affiliated Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianjun Li, M.D.
Organizational Affiliation
China Rehabilitaition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xi'an Jiaotong University Second Affiliated Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
China Rehabilitation Research Center
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22105463
Citation
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.
Results Reference
background
PubMed Identifier
20531359
Citation
Wong YW, Tam S, So KF, Chen JY, Cheng WS, Luk KD, Tang SW, Young W. A three-month, open-label, single-arm trial evaluating the safety and pharmacokinetics of oral lithium in patients with chronic spinal cord injury. Spinal Cord. 2011 Jan;49(1):94-8. doi: 10.1038/sc.2010.69. Epub 2010 Jun 8.
Results Reference
background
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Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
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