Botulinum Toxin Injections for Oral Neuropathic Pain

NCT03555916 | Completed Phase 3

• 2 other identifiers: P1509012017-002353-11
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BOTOX®-Allergan; PPTTN; Pain measurements

Outcome Measures

Primary Outcomes (1)

• Change from baseline of self-reported average pain intensity using 11-point numerical scale (0 = no pain; 10 = maximal pain imaginable) at one month

  Self-reported average pain intensity from each morning's record in a diary concerning the last 24 hours during one week, before and one month after injection

  before and one month after injection

Secondary Outcomes (15)

• Pain measurement with the 11-point numerical scale of the Brief Pain Inventory (BPI)

  At baseline, 1, 3 and 6 months

• Pain measurement with the neuropathic pain symptom inventory (NPSI)

  At baseline, 1, 3 and 6 months

• Pain measurement with Visual Analogic Scale (VAS)

  At baseline, 1, 3 and 6 months

• Pain measurements with Clinical Global Impression - Improvement scale (CGI-I)

  At baseline, 1, 3 and 6 months

• Areas of pain

  At baseline, 1, 3 and 6 months

Study Arms (2)

Drug

EXPERIMENTAL

BOTOX®, Allergan treatment in 2 mL of saline solution (0.9% NaCl) treatment

Drug: BOTOX®, Allergan

Placebo

PLACEBO COMPARATOR

2 mL of saline solution (0.9% NaCl) treatment

Drug: Placebo

Interventions

BOTOX®, Allergan DRUG

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

Also known as: BOTOX

Drug

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form signed
• Adult patients, age 18 -75 y.o.
• Medical coverage (excepted AME)
• Understanding of all medical information
• Subjects fulfilling diagnostic criteria for Peripheral painful traumatic trigeminal neuropathy (PPTTN)
• Pain in one or several branches of the trigeminal nerve
• History of surgical treatment (including endodontic treatments) in the painful area
• Pain in the area experienced in the 3 months following the treatment
• pain almost every day for at least 6 months
• VAS ≥ 30 /100 mm
• Primary painful area limited to one dental quadrant
• Presence of at least one positive (hyperalgesia, allodynia, numbness or swelling) and/or negative (anesthesia or hypoesthesia) sign of neurological dysfunction
• Pain cannot be attributed to another cause

You may not qualify if:

• Patients with impaired communication
• Pregnancy, breastfeeding or planning pregnancy within the period of the study
• Women of childbearing potential (WOCBP), adequate method of contraception within the period of the study
• Orofacial pain other than PPTTN unless clearly identifiable TMD (arthralgia, muscle pain or disc displacement)
• Contra-indications for BTX-A (for example diseases of the neuromuscular junction, known hypersensitivity to BTX-A etc.)
• Known coagulation disorders
• Major depression (score \> XX HADS scale)
• Background of drug consumption or excessive alcohol consumption (3 units of alcohol a day)
• current legal dispute with a dental practitioner
• Former use of BTX for esthetic purpose
• Dysphagia
• Aspiration pneumonitis
• Troubles with bladder control
• Topical applications of drugs and anesthetics which cannot be interrupted one week before visit sessions
• Treatment with aminoglycosides in the three months preceding the selection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Karolinska Institutet: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, France

Location

Related Publications (1)

• Moreau N, Dieb W, Descroix V, Svensson P, Ernberg M, Boucher Y. Topical Review: Potential Use of Botulinum Toxin in the Management of Painful Posttraumatic Trigeminal Neuropathy. J Oral Facial Pain Headache. 2017 Winter;31(1):7-18. doi: 10.11607/ofph.1753.

  PMID: 28118416 BACKGROUND

MeSH Terms

Conditions

Trigeminal Nerve Injuries

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Yves BOUCHER, DDS,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: June 14, 2018
• Study Start: April 4, 2019
• Primary Completion: July 19, 2022
• Study Completion: November 8, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)