Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001344
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Dextromethorphan Versus Placebo for Neuropathic Pain
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Dextromethorphan Versus Placebo for Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2000-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 mgday about 8 times the antitussive dose memantine 30-50 mgday and placebo Memantine is an NMDA antagonist used in Europe to treat Parkinsons disease and Alzheimers 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
Detailed 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 mgday about 8 times the antitussive dose memantine 30-50 mgday and placebo Memantine is an NMDA antagonist used in Europe to treat Parkinsons disease and Alzheimers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-D-0114 | None | None | None |