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

NCT01855594 | Completed Phase 2 DMC

• 1 other identifier: CN302
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Neuropathic Pain; Neuralgia; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks

  pain severity level

  D0, Wk 1, 2, 6, 12, and 24

Secondary Outcomes (10)

• Change in Multidimensional Pain Inventory Life Interference Subscale (MPI-LIS)

  D0, Wk 1, 2, 6, 12 and 24

• Change in Short-Form 36 single question

  D0, Wk 1, 2, 6, 12, and 24

• Change in Sleep Interference Assessment score

  D0, Wk 1, 2, 6, 12 and 24

• Change in weekly number of days with pain attack

  D0, Wk 1, 2, 6, 12 and 24

• Change in the Patient Global Impression of Change (PGIC)

  Wk 1, 2, 6, and 12

Study Arms (2)

Lithium treatment group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

The dose of the placebo will be adjusted according to the dummy serum level report.

Drug: Placebo

Interventions

Lithium Carbonate DRUG

250 mg/tablet, 6 weeks course of oral administration

Lithium treatment group

Placebo DRUG

placebo tablet, 6 week course of oral administration

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Spinal Cord Injury Network: lead
• China Rehabilitation Research Center: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator

Study Sites (2)

Xi'an Jiaotong University Second Affiliated Hospital

Xi’an, Shanxi, China

Location

China Rehabilitation Research Center

Beijing, China

Location

Related Publications (2)

• 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.

  PMID: 22105463 BACKGROUND

• 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.

  PMID: 20531359 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Study Officials

• Xijing He, M.D.

  Xi'an Jiaotong University Second Affiliated Hospital

  PRINCIPAL INVESTIGATOR

• Jianjun Li, M.D.

  China Rehabilitaition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2013
• First Posted: May 16, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CN (2)