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Neuropathic PainPhase 2NCT01855594

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

A Phase 2 study testing Lithium Carbonate in people with Neuropathic Pain and Neuralgia, run by China Spinal Cord Injury Network at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Neuropathic Pain, Neuralgia, Spinal Cord Injuries
What is being tested?
Lithium Carbonate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesChina
Study dates
May 2013to Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • China Rehabilitation Research Center

    Beijing

  • Xi'an Jiaotong University Second Affiliated Hospital

    Xi’an, Shanxi

Other trials in China

About this study

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

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

Read the 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

Being tested
Lithium Carbonate, Placebo
Medical subject headings
Neuralgia, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lithium CarbonateDrug

    250 mg/tablet, 6 weeks course of oral administration

  • PlaceboDrug

    placebo tablet, 6 week course of oral administration

Study groups in NCT01855594
Study groupRoleWhat they receive
Lithium treatment groupExperimentalLithium 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.
Receives: Drug: Lithium Carbonate
Control groupPlacebo comparatorThe dose of the placebo will be adjusted according to the dummy serum level report.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    pain severity level

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

Secondary outcomes (10)

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

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

  2. Change in Short-Form 36 single question

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

  3. Change in Sleep Interference Assessment score

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

  4. Change in weekly number of days with pain attack

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

  5. Change in the Patient Global Impression of Change (PGIC)

    Measured: Wk 1, 2, 6, and 12

  6. Change in Patient Health Questionnaire (PHQ-9)

    Measured: D0, Wk 1, 2, 6 and 12

  7. Change in sensory score, motor score and ASIA impairment (AIS) scale

    Measured: D0, Wk 6 and 12

  8. Change in Modified Ashworth Scale

    Measured: D0, Wk 6 and 12

  9. Magnetic resonance diffusion tensor imaging (optional)

    Measured: D0, Wk 6 and 12

  10. Electrophysiology (optional)

    Measured: D0, Wk 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01855594
Sponsor's protocol ID
CN302
Status last verified
Jan 2016
First submitted
12 May 2013
Last updated
28 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22105463

  • 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.

    PubMed 20531359

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lithium Carbonate in people with Neuropathic Pain and Neuralgia, run by China Spinal Cord Injury Network at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Numeric Rating Scale (NRS) at 24 weeks (time frame: D0, Wk 1, 2, 6, 12, and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01855594, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.

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