Dextromethorphan Versus Placebo for Neuropathic Pain
dextromethorphan
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Treatment Study
Summary
Study start date: March 1, 1993
Actual date on which the first participant was enrolled.In our current clinical trial, we are comparing the effects of two NMDA receptor antagonists to placebo in patients with painful distal symmetrical diabetic neuropathy or post-herpetic neuralgia. The treatments in this three-period crossover study are dextromethorphan, up to 920 mg/day (about 8 times the antitussive dose), memantine, 30-50 mg/day, and placebo. Memantine is an NMDA antagonist used in Europe to treat Parkinson's disease and Alzheimer's disease. The underlying hypothesis, based on studies of painful neuropathies in animal models, is that neuropathic pain is caused largely by sensitization of central nervous system neurons caused by excitatory amino acid neurotransmitters, acting largely through NMDA receptors. A previous small trial of dextromethorphan suggested efficacy in diabetic neuropathy pain. The study requires one visit to the NIH outpatient Pain Research Clinic, and consists of three 9-week treatment periods. Patients who respond to one of the medications will be invited to participate in further controlled studies of the medication followed by up to several years of open-label treatment under continued observation.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.129 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Patients must be over 18 years of age. Patients must have a definite diagnosis of diabetic neuropathy or post herpetic neuralgia or a diagnosis of neuropathic pain of various etiologies other than diabetic neuropathy or post herpetic neuralgia. Duration of symptoms must be at least 3 months. Severity of pain must be at least mild, if constant; or at least moderate, if intermittent and at least 2 hours duration a day. Patients using tricyclics, narcotics, or antiseizure medications, must keep the drug dosages constant throughout the study. No patients with unstable disease process; i.e., angina pectoris, accelerated hypertension, recent stroke or transient cerebral ischemia, uncontrolled seizures. No pregnant or lactating women. Women of child bearing potential must use birth control pills, intrauterine device, or barrier contraceptive devices. No history of significant drug abuse or PCP use. No history of IV drug abuse, prescription drug abuse, or alcoholism. No significant liver or kidney disease. No MAO inhibitors. No cognitive impairment or language difficulty as judged by difficulty completing pain diary, medical history, or telephone conversation. Patients must not have any other chronic pain condition that gives them pain greater than the neuropathy pain.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, United StatesOpen National Institute of Dental And Craniofacial Research (NIDCR) in Google Maps