NCT01435798

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response 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 three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (MTD) were first determined to establish individual dose-analgesic response relationships in a run-in period; following a washout period, subjects were then randomized to receive an order of four doses of dextromethorphan (including placebo) in a 4x4 Latin square cross-over design.

Conditions

• Central Neuropathic Pain
• Allodynia
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Dextromethorphan	0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2011-09-19
• Last updated: 2025-12-08
• Results posted: 2017-04-04

Locations

1 site across 1 country: United States