Status:
COMPLETED
Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain
Lead Sponsor:
Isabel Moreno Hay
Collaborating Sponsors:
AbbVie
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03848143
Start Date
September 11 2019
End Date
June 30 2025
Last Update
August 1 2025
Active Locations (1)
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1
Orofacial Pain Center
Lexington, Kentucky, United States, 40536