Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03848143 | Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain | PHASE2 | COMPLETED | 10 | — | — | Sep 11, 2019 | Jun 30, 2025 | Aug 1, 2025 | 1 | United States |
Patient will record the pain intensity by means of a visual analogue scale (VAS, from 0-10 being 0 no pain and 10 the worst possible pain)
| Arm | Type | Description |
|---|---|---|
| BOTOX | EXPERIMENTAL | Onabotulinum toxin A is distributed in 50 unit (50U) vacuum-dried powder bottles by Allergan (BOTOX (R)) for reconstitution only with sterile, preservative-free 0.9% Sodium Chloride Injection prior to injection. 1 mL of diluent will be drawn up to obtain a resulting dose of 10 U per 0.2 mL and injected into the vial. The BOTOX(R) will then be gently mixed with the saline by rotating the vial. The date and time of reconstitution will be recorded on the package on the label. BOTOX should be administered within 24 hours after reconstitution and stored in a refrigerator (2-8 °C). Each patient will receive 50 U of onabotulinum toxin A. |
| Name | Type | Description |
|---|---|---|
| onabotulinum toxin A | DRUG | Each subject will receive 50 units (50 U) of BoNT-A constituted in 1 mL of saline solution injected intraorally to the painful area divided in at least 3 sites, 0.5 to 1.0 cm apart depending on the size of the painful area and following a checkerboard pattern. |
Inclusion Criteria: * History of continuous dentoalveolar pain with clinically evident positive (hyperalgesia, allodynia) and/or negative (hypoaesthesia, hypoalgesia) signs of trigeminal nerve dysfunction and where other possible pain sources have been ruled out. * Intractable pain to conventional ...