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

Condition(s) targeted: Neuropathic Pain; Neuralgia; Spinal Cord Injuries

Intervention: Lithium Carbonate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: China Spinal Cord Injury Network

Official(s) and/or principal investigator(s):
Xijing He, M.D., Principal Investigator, Affiliation: Xi'an Jiaotong University Second Affiliated Hospital
Jianjun Li, M.D., Principal Investigator, Affiliation: China Rehabilitaition Research Center

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

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks

Secondary outcome:

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)

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

China Rehabilitation Research Center, Beijing, China

Xi'an Jiaotong University Second Affiliated Hospital, Xi'an, Shanxi, China

Related 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.

Starting date: May 2013
Last updated: April 14, 2015