CompletedPhase 2

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

United States26 participantsStarted 2003-04

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Percent Change in Peak Pain Intensity

Timeframe: 30 minutes post-infusion (Cmax)

Trial details

NCT IDNCT02218203

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-01

Results submitted2017-03-29

View on ClinicalTrials.gov More Central Neuropathic Pain trials