Status:
COMPLETED
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Central Neuropathic Pain
Allodynia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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) dextromethor...
Eligibility Criteria
Inclusion
- 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:
- Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal).
- For women of childbearing age: negative serum beta HCG.
- 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
- 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.
- Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry.
- Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers.
- History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
- Chronic substance abuse, including alcohol.
- Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
- Poor metabolizer of P450 2D6 substrates.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01435798
Start Date
April 1 2003
End Date
January 1 2008
Last Update
December 8 2025
Active Locations (1)
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1
Translational Pain Research, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115