Status:
COMPLETED
Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
Lead Sponsor:
China Spinal Cord Injury Network
Collaborating Sponsors:
China Rehabilitation Research Center
Second Affiliated Hospital of Xi'an Jiaotong University
Conditions:
Neuropathic Pain
Neuralgia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01855594
Start Date
May 1 2013
End Date
June 1 2015
Last Update
January 28 2016
Active Locations (2)
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1
Xi'an Jiaotong University Second Affiliated Hospital
Xi’an, Shanxi, China
2
China Rehabilitation Research Center
Beijing, China