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NCT03848143 · ClinicalTrials.gov registry record · Phase 2
Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain
A Phase 2 study, sponsored by Isabel Moreno Hay.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03848143 is a Phase 2 study that has completed, run by Isabel Moreno Hay. The registered enrollment target is 10 participants.
The verdict
NCT03848143, a Phase 2 study, has completed, sponsored by Isabel Moreno Hay.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT study concluded that BoNT-A could be used as a preventive therapy in chronic migraine patients and FDA approval was obtained. According to the International Association for the Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there are no clinical trials published investigating the effect of intraoral administration of BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to investigate the potential therapeutic effect of intraoral administration of BoNT-A in patients suffering from continuous neuropathic pain. HYPOTHESIS: There will be statistically significant differences in reported pain intensity after the intraoral administration of BOTOX® in patients suffering from chronic continuous dentoalveolar neuropathic pain. A single subject experiment will be conducted with 10 patients where 50 U of BonT-A will be injected into the painful dentoalveolar area. Eligible subjects will complete a pain diary indicating their pain intensity by means of a visual analog scale during one month to establish a baseline. After the first injection, subjects will continue to monitor the VAS daily for 3 months and the infiltration will be repeated a second time following the same protocol. Patient's response will be monitored with the daily pain diary.
Interventions
- DRUG onabotulinum toxin A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-09-11 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03848143
The ClinicalTrials.gov registry entry for NCT03848143 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Isabel Moreno Hay, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which onabotulinum toxin A is the first listed.
NCT03848143 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03848143 about?
NCT03848143 is a clinical study titled "Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain". Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attac...
What is the current status of trial NCT03848143?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2019-09-11. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT03848143?
The interventions under investigation include: onabotulinum toxin A (DRUG).
Who is sponsoring clinical trial NCT03848143?
This trial is sponsored by Isabel Moreno Hay, which has 4 total clinical trials registered on ClinicalTrials.gov.
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