Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain

NCT ID: NCT03848143

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-11
• Study Completion Date: 2025-06-30

Brief 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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BOTOX

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.

Group Type: EXPERIMENTAL

onabotulinum toxin A

Intervention Type: 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.

Interventions

onabotulinum toxin A

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.

Intervention Type: DRUG

Other Intervention Names

BOTOX

Eligibility Criteria

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 oral and/or topical pharmacotherapy for neuropathic pain according to the recommendations published by NeuPSIG (Neuropathic Pain Special Interest Group) including anticonvulsants, SNRIs (serotonin and norepinephrine reuptake inhibitors) and/or tricyclic antidepressants.
• Subject consent to participate in the study.

Exclusion Criteria

• hypersensitive to any onabotulinum toxin preparation or any component in the formulation.
• systemic nerve or muscle disorders
• bleeding disorders
• dysphagia
• breathing problems
• pregnancy or breastfeeding
• previous treatment with botulinum toxin in the last 4 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Isabel Moreno Hay

OTHER

Sponsor Role: lead

Responsible Party

Isabel Moreno Hay

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeffrey P Okeson, DMD

Role: STUDY_DIRECTOR

Associate Professor

Locations

Orofacial Pain Center

Lexington, Kentucky, United States

Countries

United States

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Other Identifiers

IIT-10247

Identifier Type: OTHER

Identifier Source: secondary_id

45231

Identifier Type: -

Identifier Source: org_study_id