Phase 2
N=26
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial
Central Neuropathic Pain · Allodynia · Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02218203 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Percent Change in Peak Pain Intensity — -2.5; -7.9; -11.2; -19.2 percentage change from baseline — p=0.0322
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dextromethorphan (Drug); Lidocaine (Drug); Placebo (Dextromethorphan) (Drug); Placebo (Lidocaine) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Peak Pain Intensity |
-2.5; -7.9; -11.2; -19.2 | 0.0322 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02218203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.