Clinical Neuropharmacology of Pain in Spinal Cord Injury

Status Completed

Clinical Trial Summary

This study is an NIH-funded two-part clinical trial to determine the best dose-ratio of individual subjects with central neuropathic pain following spinal cord injury (SCI), when two compounds with different target mechanisms are administered as combination therapy. The investigators will first determine each subjects' maximally tolerated dose (MTD) of chronic oral (PO) administration of dextromethorphan (Dex); the investigators will then randomize subjects to receive multiple dose-combinations of dextromethorphan and lidocaine (Lido). The investigators will be able to determine each subject's individual dose-response relationship for the separate compounds with adequate power, and thus also confirm the analgesic efficacy of high dose dextromethorphan and lidocaine, each in central neuropathic pain.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01435798
Study type	Interventional
Source	Brigham and Women's Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	August 2000
Completion date	January 2008

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See also
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