Botulinum Toxin Injections for Oral Neuropathic Pain

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Karolinska Institutet; University of Aarhus
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA; Pharmaceutical Solutions

Criteria

Inclusion criteria

1. Informed consent form signed

2. Adult patients, age 18 -75 y.o.

3. Medical coverage (excepted AME)

4. Understanding of all medical information

5. Subjects fulfilling diagnostic criteria for Peripheral painful traumatic trigeminal neuropathy (PPTTN)

6. Pain in one or several branches of the trigeminal nerve

7. History of surgical treatment (including endodontic treatments) in the painful area

8. Pain in the area experienced in the 3 months following the treatment

9. pain almost every day for at least 6 months

10. VAS ≥ 30 /100 mm

11. Primary painful area limited to one dental quadrant

12. Presence of at least one positive (hyperalgesia, allodynia, numbness or swelling) and/or negative (anesthesia or hypoesthesia) sign of neurological dysfunction

13. Pain cannot be attributed to another cause

Exclusion criteria

1. Patients with impaired communication

2. Pregnancy, breastfeeding or planning pregnancy within the period of the study

3. Women of childbearing potential (WOCBP), adequate method of contraception within the period of the study

4. Orofacial pain other than PPTTN unless clearly identifiable TMD (arthralgia, muscle pain or disc displacement)

5. Contra-indications for BTX-A (for example diseases of the neuromuscular junction, known hypersensitivity to BTX-A etc.)

6. Known coagulation disorders

7. Major depression (score > XX HADS scale)

8. Background of drug consumption or excessive alcohol consumption (3 units of alcohol a day)

9. current legal dispute with a dental practitioner

10. Former use of BTX for esthetic purpose

11. Dysphagia

12. Aspiration pneumonitis

13. Troubles with bladder control

14. Concomitant use of analgesics with dosage modification since less one month before inclusion in the study

15. Topical applications of drugs and anesthetics which cannot be interrupted one week before visit sessions

16. Treatment with aminoglycosides in the three months preceding the selection

17. Participation to another interventional clinical study