Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial

November 20, 2025 updated by: Christine N. Sang, MD, MPH, Brigham and Women's Hospital

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial

This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain following spinal cord injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial has several objectives:

Primary Objective To determine which combination (dose-ratio) of dextromethorphan and lidocaine provides the best balance of pain reduction and toxicity.

Secondary Objectives include To evaluate the analgesic efficacy of both dextromethorphan and lidocaine in attenuating pain related to central nervous system sensitization, specifically spontaneous pain, mechanical allodynia, and hyperalgesia.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Translational Pain Research, Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
  2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
  3. Serum laboratory examination obtained at study entry:
  4. Normal cognitive function.
  5. Signed informed consent.

Exclusion Criteria:

  1. Pregnancy or breast-feeding.
  2. Renal or hepatic dysfunction.
  3. Significant cardiac disease (e.g. MI within 1 year).
  4. Signs or symptoms of central neurological disorder, excluding SCI.
  5. Severe psychological disorder requiring treatment.
  6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
  7. Participation in a study of an investigational drug or device within 30 days prior to screening for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo- 0mg/kg Lido
Placebo in combination with 0mg/kg LBM lidocaine
Drug: Placebo (Dextromethorphan)
0mg Dextromethorphan
Drug: Placebo (Lidocaine)
0mg/kg LBM Lidocaine
Experimental: Placebo - 1mg/kg Lido
Placebo in combination with 1mg/kg LBM lidocaine
Drug: Placebo (Dextromethorphan)
0mg Dextromethorphan
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Experimental: Placebo - 2mg/kg Lido
Placebo in combination with 2mg/kg LBM lidocaine
Drug: Placebo (Dextromethorphan)
0mg Dextromethorphan
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Experimental: Placebo - 4mg/kg Lido
Placebo in combination with 4mg/kg LBM lidocaine
Drug: Placebo (Dextromethorphan)
0mg Dextromethorphan
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Experimental: Low Dose Dex - 0mg/kg Lido
Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Drug: Placebo (Lidocaine)
0mg/kg LBM Lidocaine
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: Low Dose Dex - 1mg/kg Lido
Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: Low Dose Dex - 2mg/kg Lido
Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: Low Dose Dex - 4mg/kg Lido
Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: Medium Dose Dex - 0mg/kg Lido
Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Drug: Placebo (Lidocaine)
0mg/kg LBM Lidocaine
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: Medium Dose Dex - 1mg/kg Lido
Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: Medium Dose Dex - 2mg/kg Lido
Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: Medium Dose Dex - 4mg/kg Lido
Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: High Dose Dex - 0mg/kg Lido
High dose dextromethorphan in combination with 0mg/kg LBM lidocaine
Drug: Placebo (Lidocaine)
0mg/kg LBM Lidocaine
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: High Dose Dex - 1mg/kg Lido
High dose dextromethorphan in combination with 1mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: High Dose Dex - 2mg/kg Lido
High dose dextromethorphan in combination with 2mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
Experimental: High Dose Dex - 4mg/kg Lido
High dose dextromethorphan in combination with 4mg/kg LBM lidocaine
Drug: Lidocaine
0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
Drug: Dextromethorphan
Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Peak Pain Intensity
Time Frame: 30 minutes post-infusion (Cmax)
Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.
30 minutes post-infusion (Cmax)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Christine N. Sang, MD, MPH, Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimated)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000p001387
  • R01NS041503 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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