Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical… (NCT01435798) | Clinical Trial Compass
CompletedPhase 2
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response 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 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.
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:
✓. Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
✓. Normal cognitive function.
✓. Normal communicative ability (English).
✓. Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires.
✓. Signed informed consent.
Exclusion criteria
What they're measuring
1
Mean Pain Intensity (Percent Change From Baseline)
Timeframe: 1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)