Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001725
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical Trials in Orofacial Neuralgias
Status:
COMPLETED
Status Verified Date:
2002-01
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:
This study will evaluate the safety and effectiveness of two drugs-dextromethorphan and topiramate-in treating orofacial mouth and face pain Dextromethorphan a commonly used cough suppressant and topiramate an anti-seizure medicine block certain receptors on brain and spinal nerve cells that may cause the cells to produce electrical discharges and pain
Patients 18 years of age and older with oral and facial pain with trigeminal nerve damage and who have had pain daily for at least 3 months may be eligible for this study Candidates will be screened with a medical history physical examination blood tests and psychiatric evaluation These results will serve as baseline values for participants Those enrolled in the study will take either dextromethorphan or topiramate in a 2-part study as follows
Dextromethorphan
In Part 1 patients will take dextromethorphan and lorazepam a commonly used anti-anxiety drug separately in two 6-week periods Lorazepam is used in this study as an active placebo for comparison with dextromethorphan An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug They will take dextromethorphan for 4 weeks to determine the maximum tolerated dose the highest dose that does not cause troubling side effects and will stay on that dose for the remaining 2 weeks Then they will repeat this process with lorazepam Patients who respond to either drug may continue with Part 2 of the study which compares these two drugs four more times to confirm the response seen in Part 1 In Part 2 the maximum tolerated dose will be determined in a 2-week period and that dose will be continued for another 2 weeks This procedure will be repeated eight times Throughout the study patients will keep a daily pain diary They will be contacted by telephone 2 to 3 times a week during dose escalation to check for side effects At the end of each of the two 6-week periods in Part 1 and at the end of each 4-week period in Part 2 of the study patients will have a 1-hour clinic visit Participants who live more than a few hours drive from NIH will have a full telephone follow-up evaluation instead of the clinic visits
Topiramate
Patients who receive topiramate will follow a plan similar to that described above for dextromethorphan with the following exceptions They will take topiramate and an inactive placebo a look-alike pill that has no active ingredients in two separate 12-week periods Patients maximum tolerated dose will be determined in the first 8 weeks and they will stay on that dose for the remaining 4 weeks of each period Patients who respond to the medication in Part 1 may continue with Part 2 to confirm the response Part 2 consists of six 6-week periods The first 4 weeks of each will be used to determine the maximum tolerated dose and the patient will remain on that dose for the next 2 weeks Patients will keep a daily pain diary and will be contacted by phone 2 to 3 times a week while doses are being increased Patients who complete Part 2 of the topiramate study may participate in another phase of the study that will last for 2 years Those who continue for this phase will take topiramate for the 2-year period They will be followed regularly by a study nurse and will come to NIH every 6 months for a follow-up visit
Patients 18 years of age and older with oral and facial pain with trigeminal nerve damage and who have had pain daily for at least 3 months may be eligible for this study Candidates will be screened with a medical history physical examination blood tests and psychiatric evaluation These results will serve as baseline values for participants Those enrolled in the study will take either dextromethorphan or topiramate in a 2-part study as follows
Dextromethorphan
In Part 1 patients will take dextromethorphan and lorazepam a commonly used anti-anxiety drug separately in two 6-week periods Lorazepam is used in this study as an active placebo for comparison with dextromethorphan An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug They will take dextromethorphan for 4 weeks to determine the maximum tolerated dose the highest dose that does not cause troubling side effects and will stay on that dose for the remaining 2 weeks Then they will repeat this process with lorazepam Patients who respond to either drug may continue with Part 2 of the study which compares these two drugs four more times to confirm the response seen in Part 1 In Part 2 the maximum tolerated dose will be determined in a 2-week period and that dose will be continued for another 2 weeks This procedure will be repeated eight times Throughout the study patients will keep a daily pain diary They will be contacted by telephone 2 to 3 times a week during dose escalation to check for side effects At the end of each of the two 6-week periods in Part 1 and at the end of each 4-week period in Part 2 of the study patients will have a 1-hour clinic visit Participants who live more than a few hours drive from NIH will have a full telephone follow-up evaluation instead of the clinic visits
Topiramate
Patients who receive topiramate will follow a plan similar to that described above for dextromethorphan with the following exceptions They will take topiramate and an inactive placebo a look-alike pill that has no active ingredients in two separate 12-week periods Patients maximum tolerated dose will be determined in the first 8 weeks and they will stay on that dose for the remaining 4 weeks of each period Patients who respond to the medication in Part 1 may continue with Part 2 to confirm the response Part 2 consists of six 6-week periods The first 4 weeks of each will be used to determine the maximum tolerated dose and the patient will remain on that dose for the next 2 weeks Patients will keep a daily pain diary and will be contacted by phone 2 to 3 times a week while doses are being increased Patients who complete Part 2 of the topiramate study may participate in another phase of the study that will last for 2 years Those who continue for this phase will take topiramate for the 2-year period They will be followed regularly by a study nurse and will come to NIH every 6 months for a follow-up visit
Detailed Description:
Some of the clinical features of trigeminal and other facial neuralgias suggest that these painful disorders may be associated with sensitization of central nervous system neurons Laboratory evidence has shown that central sensitization can be produced and maintained by excitatory amino acids eg glutamate acting on neurons at NMDA and AMPAkainate receptor sites Given this information and the need for more effective treatments of orofacial neuropathic pain syndromes two possible candidates worthy of study are 1 dextromethorphan an NMDA receptor antagonist and 2 topiramate an anticonvulsant drug with AMPAkainate receptor blocking activity Thus the purpose of this study is to evaluate the efficacy and safety of topiramate TPM or high-dose dextromethorphan DM versus placebo in the treatment of pain in patients with trigeminal neuralgia TN and other orofacial neuropathic pain syndromes We propose two 6 month studies respectively evaluating dextromethorphan 60 patients at least 20 with TN 20 with definite trigeminal nerve pathology and 20 with likely trigeminal nerve pathology and topiramate 40 patients at least 20 with TN 20 with definite trigeminal nerve pathology These will be double-blind randomized crossover designs comparing high-dose dextromethorphan DM versus lorazepam LOR as an active placebo OR topiramate versus inactive placebo The primary study outcome measure in both parts will be overall daily pain assessed by Gracely pain intensity descriptors Other recorded data will include adverse drug effects the frequency severity and duration of pain paroxysms and a questionnaire focusing on daily function modification of the Brief Pain Inventory
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 |
|---|---|---|---|
| 98-D-0042 | None | None | None |