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

NCT02218203 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2000p001387R01NS041503
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Neuropathic Pain; Allodynia; Spinal Cord Injury

Keywords

chronic pain; central neuropathic pain; spinal cord injury; dextromethorphan; lidocaine; combination therapy; analgesia

Outcome Measures

Primary Outcomes (1)

• Percent Change in Peak Pain Intensity

  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)

Study Arms (16)

Placebo- 0mg/kg Lido

PLACEBO COMPARATOR

Placebo in combination with 0mg/kg LBM lidocaine

Drug: Placebo (Dextromethorphan); Drug: Placebo (Lidocaine)

Placebo - 1mg/kg Lido

EXPERIMENTAL

Placebo in combination with 1mg/kg LBM lidocaine

Drug: Lidocaine; Drug: Placebo (Dextromethorphan)

Placebo - 2mg/kg Lido

EXPERIMENTAL

Placebo in combination with 2mg/kg LBM lidocaine

Drug: Lidocaine; Drug: Placebo (Dextromethorphan)

Placebo - 4mg/kg Lido

EXPERIMENTAL

Placebo in combination with 4mg/kg LBM lidocaine

Drug: Lidocaine; Drug: Placebo (Dextromethorphan)

Low Dose Dex - 0mg/kg Lido

EXPERIMENTAL

Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Placebo (Lidocaine)

Low Dose Dex - 1mg/kg Lido

EXPERIMENTAL

Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

Low Dose Dex - 2mg/kg Lido

EXPERIMENTAL

Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

Low Dose Dex - 4mg/kg Lido

EXPERIMENTAL

Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

Medium Dose Dex - 0mg/kg Lido

EXPERIMENTAL

Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Placebo (Lidocaine)

Medium Dose Dex - 1mg/kg Lido

EXPERIMENTAL

Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

Medium Dose Dex - 2mg/kg Lido

EXPERIMENTAL

Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

Medium Dose Dex - 4mg/kg Lido

EXPERIMENTAL

Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

High Dose Dex - 0mg/kg Lido

EXPERIMENTAL

High dose dextromethorphan in combination with 0mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Placebo (Lidocaine)

High Dose Dex - 1mg/kg Lido

EXPERIMENTAL

High dose dextromethorphan in combination with 1mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

High Dose Dex - 2mg/kg Lido

EXPERIMENTAL

High dose dextromethorphan in combination with 2mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

High Dose Dex - 4mg/kg Lido

EXPERIMENTAL

High dose dextromethorphan in combination with 4mg/kg LBM lidocaine

Drug: Dextromethorphan; Drug: Lidocaine

Interventions

Lidocaine DRUG

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)

High Dose Dex - 1mg/kg Lido; High Dose Dex - 2mg/kg Lido; High Dose Dex - 4mg/kg Lido; Low Dose Dex - 1mg/kg Lido; Low Dose Dex - 2mg/kg Lido; Low Dose Dex - 4mg/kg Lido; Medium Dose Dex - 1mg/kg Lido; Medium Dose Dex - 2mg/kg Lido; Medium Dose Dex - 4mg/kg Lido; Placebo - 1mg/kg Lido; Placebo - 2mg/kg Lido; Placebo - 4mg/kg Lido

Dextromethorphan DRUG

Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)

High Dose Dex - 0mg/kg Lido; High Dose Dex - 1mg/kg Lido; High Dose Dex - 2mg/kg Lido; High Dose Dex - 4mg/kg Lido; Low Dose Dex - 0mg/kg Lido; Low Dose Dex - 1mg/kg Lido; Low Dose Dex - 2mg/kg Lido; Low Dose Dex - 4mg/kg Lido; Medium Dose Dex - 0mg/kg Lido; Medium Dose Dex - 1mg/kg Lido; Medium Dose Dex - 2mg/kg Lido; Medium Dose Dex - 4mg/kg Lido

Placebo (Dextromethorphan) DRUG

0mg Dextromethorphan

Placebo - 1mg/kg Lido; Placebo - 2mg/kg Lido; Placebo - 4mg/kg Lido; Placebo- 0mg/kg Lido

Placebo (Lidocaine) DRUG

0mg/kg LBM Lidocaine

High Dose Dex - 0mg/kg Lido; Low Dose Dex - 0mg/kg Lido; Medium Dose Dex - 0mg/kg Lido; Placebo- 0mg/kg Lido

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
• Serum laboratory examination obtained at study entry:
• Normal cognitive function.
• Signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Translational Pain Research, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

• Translational Pain Research, Brigham and Women's Hospital

MeSH Terms

Conditions

Hyperalgesia; Spinal Cord Injuries; Chronic Pain; Agnosia

Interventions

Dextromethorphan; Lidocaine

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Christine N. Sang, MD, MPH
• Organization: Translational Pain Research, Brigham and Women's Hospital

paintrials@partners.org

617-525-7246

Study Officials

• Christine N. Sang, MD, MPH

  Translational Pain Research, Brigham and Women's Hospital (Disclosure: Patent)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Translational Pain Research

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 18, 2014
• Study Start: April 1, 2003
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 8, 2025
• Results First Posted: March 22, 2018

Record last verified: 2025-11

Locations

US (1)