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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855594
• Other study ID #: CN302
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2013
• Last updated: January 26, 2016
• Start date: May 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: China Spinal Cord Injury Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries

Intervention

Drug:
• Lithium Carbonate
250 mg/tablet, 6 weeks course of oral administration
• Placebo
placebo tablet, 6 week course of oral administration

Locations

Country	Name	City	State
China	China Rehabilitation Research Center	Beijing
China	Xi'an Jiaotong University Second Affiliated Hospital	Xi'an	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
China Spinal Cord Injury Network	China Rehabilitation Research Center, Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks	pain severity level	D0, Wk 1, 2, 6, 12, and 24	No
Secondary	Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS)		D0, Wk 1, 2, 6, 12 and 24	No
Secondary	Change in Short-Form 36 single question		D0, Wk 1, 2, 6, 12, and 24	No
Secondary	Change in Sleep Interference Assessment score		D0, Wk 1, 2, 6, 12 and 24	No
Secondary	Change in weekly number of days with pain attack		D0, Wk 1, 2, 6, 12 and 24	No
Secondary	Change in the Patient Global Impression of Change (PGIC)		Wk 1, 2, 6, and 12	No
Secondary	Change in Patient Health Questionnaire (PHQ-9)		D0, Wk 1, 2, 6 and 12	No
Secondary	Change in sensory score, motor score and ASIA impairment (AIS) scale		D0, Wk 6 and 12	No
Secondary	Change in Modified Ashworth Scale		D0, Wk 6 and 12	No
Secondary	Magnetic resonance diffusion tensor imaging (optional)		D0, Wk 6 and 12	No
Secondary	Electrophysiology (optional)		D0, Wk 6 and 12	No