Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Spinal Cord Injury Network
• Collaborators: China Rehabilitation Research Center; Second Affiliated Hospital of Xi'an Jiaotong University
• Treatments: Lithium Carbonate

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.