Clinical trial NCT01855594: Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Neuralgia
Spinal Cord Injuries
Lead sponsor: China Spinal Cord Injury Network
Sponsor class: NETWORK
Collaborators: name: China Rehabilitation Research Center
name: Second Affiliated Hospital of Xi'an Jiaotong University
First posted: 2013-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks
timeFrame: D0, Wk 1, 2, 6, 12, and 24
Secondary outcomes:
measure: Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS)
timeFrame: D0, Wk 1, 2, 6, 12 and 24
measure: Change in Short-Form 36 single question
timeFrame: D0, Wk 1, 2, 6, 12, and 24
measure: Change in Sleep Interference Assessment score
timeFrame: D0, Wk 1, 2, 6, 12 and 24
measure: Change in weekly number of days with pain attack
timeFrame: D0, Wk 1, 2, 6, 12 and 24
measure: Change in the Patient Global Impression of Change (PGIC)
timeFrame: Wk 1, 2, 6, and 12
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: D0, Wk 1, 2, 6 and 12
measure: Change in sensory score, motor score and ASIA impairment (AIS) scale
timeFrame: D0, Wk 6 and 12
measure: Change in Modified Ashworth Scale
timeFrame: D0, Wk 6 and 12
measure: Magnetic resonance diffusion tensor imaging (optional)
timeFrame: D0, Wk 6 and 12
measure: Electrophysiology (optional)
timeFrame: D0, Wk 6 and 12
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Jiaotong University Second Affiliated Hospital
state: Shanxi
city: Beijing
country: China
facility: China Rehabilitation Research Center
Study officials:
affiliation: Xi'an Jiaotong University Second Affiliated Hospital
name: Xijing He, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Rehabilitaition Research Center
name: Jianjun Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.