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Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial

CompletedPhase 2NCT01435798
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial
Conditions
Interventions
  • Drug: Dextromethorphan
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Start date
2003-04
Primary completion
2008-01
Sex
All
Age range
from 18 Years to 70 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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: * Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal). * For women of childbearing age: negative serum beta HCG. 4. Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control. 5. Normal cognitive function. 6. Normal communicative ability (English). 7. Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires. 8. 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. Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry. 7. Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers. 8. History of hypersensitivity or intolerance to dextromethorphan or lidocaine. 9. Chronic substance abuse, including alcohol. 10. Participation in a study of an investigational drug or device within 30 days prior to screening for this study. 11. Poor metabolizer of P450 2D6 substrates.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01435798