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Botulinum Toxin Injections for Oral Neuropathic Pain (TRIGTOX)

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ClinicalTrials.gov Identifier: NCT03555916
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Karolinska Institutet
University of Aarhus
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuropathy, Traumatic Drug: BOTOX®, Allergan Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Use of Botulinum Toxin (BTX) for the Treatment of Peripheral Painful Traumatic Trigeminal Neuropathy (PPTTN)
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Drug
BOTOX®, Allergan treatment in 2 mL of saline solution (0.9% NaCl) treatment
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
Other Name: BOTOX

Placebo Comparator: Placebo
2 mL of saline solution (0.9% NaCl) treatment
Drug: Placebo
2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection




Primary Outcome Measures :
  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 [ Time Frame: before and one month after injection ]
    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


Secondary Outcome Measures :
  1. Pain measurement with the 11-point numerical scale of the Brief Pain Inventory (BPI) [ Time Frame: At baseline, 1, 3 and 6 months ]
    Pain recorded each morning in a diary (diary 2) concerning the last 24 hours, using the 11-point numerical scale (NS; 0 = no pain; 10 = maximal pain imaginable) of the Brief Pain Inventory (BPI) at 1 month, 3 months and 6 months. The least, average, and maximum pain intensity during the 7 days will be collected and compared to baseline.

  2. Pain measurement with the neuropathic pain symptom inventory (NPSI) [ Time Frame: At baseline, 1, 3 and 6 months ]
    Items of the neuropathic pain symptom inventory (NPSI) will be recorded during the last 24 hours on 11-points (0-10 points) numerical scales.

  3. Pain measurement with Visual Analogic Scale (VAS) [ Time Frame: At baseline, 1, 3 and 6 months ]
    Visual Analogic Scale (VAS) (from 0 mm [no pain relief] to 100 mm [maximal pain relief]).

  4. Pain measurements with Clinical Global Impression - Improvement scale (CGI-I) [ Time Frame: At baseline, 1, 3 and 6 months ]
    The Clinical Global Impression - Improvement scale (CGI-I) (a 7-point scale rating from very much improved to very much worse) will be used .

  5. Areas of pain [ Time Frame: At baseline, 1, 3 and 6 months ]
    The areas of main pain and referred pain will be reported directly from the patient to a soft foil, then digitized for measurement on Image J software.

  6. Assessment of sensory deficit according to intraoral Quantitative Sensory Testing (QST) [ Time Frame: At baseline, 1, 3 and 6 months ]

    According to the conclusions of the European task force committee for intraoral quantitative sensory testing (QST), the QST is defined by :

    • Brush-induced allodynia will be evaluated stroking the skin with a standardized brush and will be considered as present if evoking a clear sensation of pain. The intensity of allodynia will be recorded on a 100 mm visual analog scale. Area of Brush-induced allodynia will be traced on a transparent plastic foil, and then digitized for measurement on Image J software.
    • Mechanical sensations (detection thresholds to non-painful stimuli) and pain thresholds will be measured with calibrated von Frey hairs (0.06-300gm) (Bioseb, France) (or electronic von Frey, Bioseb France).
    • Thermal sensations and pain thresholds (in °C) will be assessed with a thermoalgometer (TSA II; Medoc, Israel) with an intraoral thermode by the method of limits, with baseline temperatures adjusted to the patient's skin temperature .

  7. Emotional state with Hospital Anxiety and Depression Scale (HADS) [ Time Frame: At baseline, 1, 3 and 6 months ]
    Emotional state using the Hospital Anxiety and Depression Scale (HADS) including 14 items scored as anxiety and depression scores (each on 21)

  8. Emotional state with Brief Pain Inventory (BPI). [ Time Frame: At baseline, 1, 3 and 6 months ]
    Emotional state using items of the Brief Pain Inventory (BPI).

  9. Movement and function [ Time Frame: At baseline, 1, 3 and 6 months ]
    Interference with oral function will be measured with the Brief Pain Inventory (BPI) (with the exclusion of the item "ability to walk" changed for "ability to chew" judged more relevant here) rated from 0 (does not interfere) to 10 (complete interference).

  10. Quality of life with Geriatric Oral Health Assessment Index (GOHAI) [ Time Frame: At baseline, 1, 3 and 6 months ]
    Quality of life will be assessed with specific questionnaires Geriatric Oral Health Assessment Index (GOHAI)

  11. Quality of life with Oral Health Impact Profile (OHIP) [ Time Frame: At baseline, 1, 3 and 6 months ]
    Quality of life will be assessed with specific Oral Health Impact Profile (OHIP)

  12. Quality of life with items of Brief Pain Inventory (BPI). [ Time Frame: At baseline, 1, 3 and 6 months ]
  13. Incidence of BTX-A - Emergent Adverse event [ Time Frame: At baseline, 1, 3 and 6 months ]
    Safety of BTX-A, particularly for potential systemic adverse effects, will be assessed throughout the study. Adverse events will be declared in the case report form (CRF).

  14. Pain related to injections of BTX-A [ Time Frame: At baseline, 1, 3 and 6 months ]
    Pain related to injections will be rated as mild, moderate, or severe.

  15. Time course of the pain: [ Time Frame: At baseline, 1, 3 and 6 months ]
    measurement of the time course of the pain throughout the day with a diary (diary 1) in which the patient reports his/her pain every hour on a numeric scale (0-10) during 7 days.

  16. Thermography [ Time Frame: At baseline, 1, 3 and 6 months ]
    measurement (in °C), by a camera with a thermal sensitivity



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555916


Contacts
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Contact: Yves BOUCHER, DDS,PhD 01 42 16 14 56 yves.boucher@univ-paris-diderot.fr

Locations
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France
Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France
Contact: Boucher Yves, DDS, PhD    01 42 16 14 56    yves.boucher@univ-paris-diderot.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Karolinska Institutet
University of Aarhus
Investigators
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Principal Investigator: Yves BOUCHER, DDS,PhD Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03555916     History of Changes
Other Study ID Numbers: P150901
2017-002353-11 ( EudraCT Number )
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
BOTOX®-Allergan
PPTTN
Pain measurements
Additional relevant MeSH terms:
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Trigeminal Nerve Diseases
Trigeminal Nerve Injuries
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Nervous System Diseases
Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pharmaceutical Solutions
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents