Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 12, 2013
First Posted Date  ICMJE May 16, 2013
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE May 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks [ Time Frame: D0, Wk 1, 2, 6, 12, and 24 ]
pain severity level
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2014)
  • Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS) [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
  • Change in Short-Form 36 single question [ Time Frame: D0, Wk 1, 2, 6, 12, and 24 ]
  • Change in Sleep Interference Assessment score [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
  • Change in weekly number of days with pain attack [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
  • Change in the Patient Global Impression of Change (PGIC) [ Time Frame: Wk 1, 2, 6, and 12 ]
  • Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: D0, Wk 1, 2, 6 and 12 ]
  • Change in sensory score, motor score and ASIA impairment (AIS) scale [ Time Frame: D0, Wk 6 and 12 ]
  • Change in Modified Ashworth Scale [ Time Frame: D0, Wk 6 and 12 ]
  • Magnetic resonance diffusion tensor imaging (optional) [ Time Frame: D0, Wk 6 and 12 ]
  • Electrophysiology (optional) [ Time Frame: D0, Wk 6 and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
  • Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS) [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
  • Change in Short-Form 36 single question [ Time Frame: D0, Wk 1, 2, 6, 12, and 24 ]
  • Change in Sleep Interference Assessment score [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
  • Change in weekly number of days with pain attack [ Time Frame: D0, Wk 1, 2, 6, 12 and 24 ]
  • Change in the Patient Global Impression of Change (PGIC) [ Time Frame: Wk 1, 2, 6, and 12 ]
  • Change in PHQ-9 [ Time Frame: D0, Wk 1, 2, 6 and 12 ]
  • Change in AISA sensory scores, motor scores and AISA impairment scale [ Time Frame: D0, Wk 6 and 12 ]
  • Change in Modified Asworth Scale [ Time Frame: D0, Wk 6 and 12 ]
  • Magnetic resonance diffusion tensor imaging (optional) [ Time Frame: D0, Wk 6 and 12 ]
  • Electrophysiology (optional) [ Time Frame: D0, Wk 6 and 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathic Pain
  • Neuralgia
  • Spinal Cord Injuries
Intervention  ICMJE
  • Drug: Lithium Carbonate
    250 mg/tablet, 6 weeks course of oral administration
  • Drug: Placebo
    placebo tablet, 6 week course of oral administration
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Lithium Carbonate
  • Placebo Comparator: Control group
    The dose of the placebo will be adjusted according to the dummy serum level report.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01855594
Other Study ID Numbers  ICMJE CN302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Spinal Cord Injury Network
Study Sponsor  ICMJE China Spinal Cord Injury Network
Collaborators  ICMJE
  • China Rehabilitation Research Center
  • Second Affiliated Hospital of Xi'an Jiaotong University
Investigators  ICMJE
Principal Investigator: Xijing He, M.D. Xi'an Jiaotong University Second Affiliated Hospital
Principal Investigator: Jianjun Li, M.D. China Rehabilitaition Research Center
PRS Account China Spinal Cord Injury Network
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP