NCT01855594

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: China Spinal Cord Injury Network · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neuropathic Pain
• Neuralgia
• Spinal Cord Injuries

Interventions

Type	Name	Description
DRUG	Lithium Carbonate	250 mg/tablet, 6 weeks course of oral administration
DRUG	Placebo	placebo tablet, 6 week course of oral administration

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-05-16
• Last updated: 2016-01-28

Locations

2 sites across 1 country: China