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

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

Study Overview

• Status: Completed
• Conditions: Neuralgia; Neuropathic Pain; Spinal Cord Injuries
• Intervention / Treatment: Drug: Lithium Carbonate; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • China Rehabilitation Research Center
  • Shanxi
    • Xi'an, Shanxi, China
      • Xi'an Jiaotong University Second Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Lithium Carbonate; 250 mg/tablet, 6 weeks course of oral administration
PLACEBO_COMPARATOR: Control group; The dose of the placebo will be adjusted according to the dummy serum level report.	Drug: Placebo; placebo tablet, 6 week course of oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks	pain severity level	D0, Wk 1, 2, 6, 12, and 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS)	D0, Wk 1, 2, 6, 12 and 24
Change in Short-Form 36 single question	D0, Wk 1, 2, 6, 12, and 24
Change in Sleep Interference Assessment score	D0, Wk 1, 2, 6, 12 and 24
Change in weekly number of days with pain attack	D0, Wk 1, 2, 6, 12 and 24
Change in the Patient Global Impression of Change (PGIC)	Wk 1, 2, 6, and 12
Change in Patient Health Questionnaire (PHQ-9)	D0, Wk 1, 2, 6 and 12
Change in sensory score, motor score and ASIA impairment (AIS) scale	D0, Wk 6 and 12
Change in Modified Ashworth Scale	D0, Wk 6 and 12
Magnetic resonance diffusion tensor imaging (optional)	D0, Wk 6 and 12
Electrophysiology (optional)	D0, Wk 6 and 12

Collaborators and Investigators

• Sponsor: China Spinal Cord Injury Network
• Collaborators: Second Affiliated Hospital of Xi'an Jiaotong University; China Rehabilitation Research Center
• Investigators: Principal Investigator: Xijing He, M.D., Xi'an Jiaotong University Second Affiliated Hospital; Principal Investigator: Jianjun Li, M.D., China Rehabilitaition Research Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: May 12, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (ESTIMATE): May 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Wounds and Injuries; Spinal Cord Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: CN302