Search / Trial NCT00001344

Dextromethorphan Versus Placebo for Neuropathic Pain

Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Dec 9, 2002

Apply for Trial

Trial Information

Current as of June 13, 2024

Completed

Keywords

Diabetes Mellitus Diabetic Neuropathy Memantine Nmda Receptor Antagonists Neuropathic Pain Neuropathy Post Herpetic Neuralgia Shingles

Description

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 s...

Gender

All

Eligibility 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.

Attachments

readout_NCT00001344_2024-06-13.pdf

4.5 MB

NCT00001344_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0