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Botulinum Toxin Injections for Oral Neuropathic Pain

NCT03555916 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-04-10

No results posted yet for this study

Summary

Peripheral painful traumatic trigeminal neuropathy (PPTTN) are poorly relieved by existing treatments which in addition induce many adverse effects. BTX, which blocks the exocytosis of neurotransmitters, can be captured by axonal retrograde transport in primary nociceptive neurons. Injected in the painful area, it might therefore inhibit the release of algogenic neurotransmitters, at both the peripheral and central levels and thus reduce pain. One study reported such an effect in neuropathic spinal pain. A recent study reported an analgesic effect in trigeminal neuralgia.

Conditions

  • Trigeminal Neuropathy, Traumatic

Interventions

DRUG

BOTOX®, Allergan

50 U BTX-A (BOTOX®, Allergan) powder diluted in 2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection

DRUG

Placebo

2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • University of Aarhus

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Yves BOUCHER, DDS,PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2022-07-19
Completion
2022-11-08

Countries

  • France

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555916 on ClinicalTrials.gov