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

Brigham and Women's Hospital26 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Central Neuropathic Pain Allodynia Spinal Cord Injury

Interventions

DextromethorphanDRUG

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

LidocaineDRUG

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)

Placebo (Dextromethorphan)DRUG

0mg Dextromethorphan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Translational Pain Research, Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 minutes post-infusion (Cmax)

Data from ClinicalTrials.gov

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