NCT02218203

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Central Neuropathic Pain
• Allodynia
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Dextromethorphan	Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
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	Placebo (Dextromethorphan)	0mg Dextromethorphan
DRUG	Placebo (Lidocaine)	0mg/kg LBM Lidocaine

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2014-08-18
• Last updated: 2025-12-08
• Results posted: 2018-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study