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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Dextromethorphan; Lidocaine

Criteria

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.