Spinal Cord Injury Clinical Trial
Official title:
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial
Verified date | March 2018 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions 3. Serum laboratory examination obtained at study entry: 4. Normal cognitive function. 5. Signed informed consent. Exclusion Criteria: 1. Pregnancy or breast-feeding. 2. Renal or hepatic dysfunction. 3. Significant cardiac disease (e.g. MI within 1 year). 4. Signs or symptoms of central neurological disorder, excluding SCI. 5. Severe psychological disorder requiring treatment. 6. History of hypersensitivity or intolerance to dextromethorphan or lidocaine. 7. Participation in a study of an investigational drug or device within 30 days prior to screening for this study. |
Country | Name | City | State |
---|---|---|---|
United States | Translational Pain Research, Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change in Peak Pain Intensity | Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity. | 30 minutes post-infusion (Cmax) |
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