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

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ClinicalTrials.gov Identifier: NCT01855594
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : January 28, 2016
Sponsor:
Collaborators:
China Rehabilitation Research Center
Second Affiliated Hospital of Xi'an Jiaotong University
Information provided by (Responsible Party):
China Spinal Cord Injury Network

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Neuralgia Spinal Cord Injuries Drug: Lithium Carbonate Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks [ Time Frame: D0, Wk 1, 2, 6, 12, and 24 ]
    pain severity level


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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855594


Locations
China, Shanxi
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an, Shanxi, China
China
China Rehabilitation Research Center
Beijing, China
Sponsors and Collaborators
China Spinal Cord Injury Network
China Rehabilitation Research Center
Second Affiliated Hospital of Xi'an Jiaotong University
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:
Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT01855594     History of Changes
Other Study ID Numbers: CN302
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs