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NCT00001725 · ClinicalTrials.gov registry record · Phase 2
Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain
A Phase 2 study of Pain and Trigeminal Neuralgia, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT00001725: Completed Phase 2 study of Pain and Trigeminal Neuralgia, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT00001725 is a Phase 2 study of Pain and Trigeminal Neuralgia that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 100 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001725, a Phase 2 study of Pain and Trigeminal Neuralgia, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 Pa
Conditions Studied
Interventions
- DRUG Dextromethorphan
Study Locations (1)
Maryland
- National Institute of Dental And Craniofacial Research (NIDCR) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 1997-12 |
| Est. Completion | 2002-01 |
| Phase | Phase 2 |
What the finished NCT00001725 record still lists
NCT00001725 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (67% lower).
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Dextromethorphan is the first listed.
NCT00001725 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001725 about?
NCT00001725 is a clinical study titled "Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain". 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 ...
What is the current status of trial NCT00001725?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 1997-12. Estimated completion is 2002-01.
What conditions does trial NCT00001725 study?
This clinical trial studies the following conditions: Pain, Trigeminal Neuralgia, Facial Neuralgia.
What interventions are being tested in trial NCT00001725?
The interventions under investigation include: Dextromethorphan (DRUG).
Who is sponsoring clinical trial NCT00001725?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001725 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001725's enrollment target sits among peer trials
100 164th of 374 higher than 201 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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