Botox Injections for Patients With Persistent Facial Pain

NCT03462290 | Completed Phase 2

• 2 other identifiers: 010817-02017-002518-30
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to investigate efficacy and safety of injecting botulinum toxin towards the sphenopalatine ganglion using MultiGuide in patients with persistent idiopathic facial pain

Conditions

Facial Pain

Keywords

Botulinum Toxins, Type A; Injections; Sphenopalatine Ganglion Block

Outcome Measures

Primary Outcomes (1)

• Changes from baseline to weeks 5-8 in Numeric Pain Rating Scale (NRS) score for persistent idiopathic facial pain (PIFP)

  NRS score for persistent idiopathic facial pain (PIFP) as registered in the pain diary in the active group versus the placebo group. Responders are defined as those with at least 30% reduction in NRS for PIFP in weeks 5- 8 compared to baseline

  5-8 weeks

Secondary Outcomes (7)

• Percentage of patients with pain intensity rating 1-3 (mild pain)

  8 weeks

• Physical functioning assessed by a Multidimensional Pain Inventory or Brief Pain Inventory interference scale

  8 weeks

• Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS)

  8 weeks

• Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC)

  8 weeks

• Number of days without persistent idiopathic facial pain

  8 weeks

Study Arms (2)

Botulinum toxin

EXPERIMENTAL

Drug: botulinum toxin type A; Drug: placebo

placebo

PLACEBO COMPARATOR

Drug: botulinum toxin type A; Drug: placebo

Interventions

botulinum toxin type A DRUG

Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide

Also known as: botox

Botulinum toxin; placebo

placebo DRUG

solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide

Botulinum toxin; placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent Idiopathic Facial Pain fulfilling diagnostic criteria as classified in The International Classification of Headache Disorders, 3rd edition (ICHD-3 beta version) as modified by the authors of this trial. See below.
• Unsatisfactory effect of available treatment methods as evaluated by a neurologist, ENT specialist or maxillofacial surgeon. The patient should have failed treatment with both anticonvulsant as carbamazepine (Tegretol, Carbatrol) and antidepressant as tricyclic antidepressants
• Average Pain intensity ≥4 (0-10) in Numeric Pain Rating Scale (NRS) on the affected side during the 4-week baseline period
• Written informed consent from the patient
• Modified diagnostic criteria for PIFP according to The International
• Classification of Headache Disorders, 3rd edition (ICHD-3 beta version):
• A. Facial and/or oral pain fulfilling criteria B and C.
• B. Recurring daily for \>2 hr per day for \>3 months
• C. Pain has both of the following characteristics:
• Poorly localized and may radiate beyond the trigeminal nerve distribution
• Dull, aching or nagging quality D. Clinical neurological examination is normal, however patient may denote paresthesia E. A dental cause has been excluded by appropriate investigations; signs of structural pathology or other specific causes of pain are not identified. Minor operation and injury (insignificant trauma e.g. tooth extraction) to the face, maxilla, teeth and gums without a direct causal relationship with the pain regarding both time and site is accepted. F. Not better accounted for by another ICHD-3 diagnosis.

You may not qualify if:

• Bilateral symmetrically affected
• Neurological disorders or other related systemic diseases that can explain the pain
• MRI/CT examination confirming intracranial pathology.
• Systemic or local disease or condition that can give a significantly increased risk of complications to the particular procedure
• Not competent to asses informed consent based on neurological assessment
• Psychiatric disorder that prevents the completion of the study
• Pregnancy
• Inappropriate use of contraception
• Breastfeeding
• Abuse or unauthorized use of medication, drugs or alcohol
• Allergy or other hypersensitivity reactions to marcaine, lidocaine, xylocaine, or adrenaline, possibly similar related drugs
• Anatomical factors that prevent or impede the injection
• Known hypersensitivity to botulinum toxin type A or to any of the excipients
• Treatment with drugs that can interact with botulinum toxin type A: aminoglycoside antibiotics, spectinomycin, neuromuscular blockers, both depolarizing (succinylcholine) and non-depolarizing (tubocurarine derivatives), lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Department of Neuroscience, Faculty of Medicine and Health Science, NTNU

Trondheim, Norway

Location

Related Publications (1)

• Jamtoy KA, Thorstensen WM, Stovner LJ, Rosen A, Maarbjerg S, Bratbak D, Simpson MR, Tronvik E. Onabotulinum toxin A block of the sphenopalatine ganglion in patients with persistent idiopathic facial pain: a randomized, triple-blind, placebo-controlled, exploratory, cross-over study. Cephalalgia. 2023 Jul;43(7):3331024231187132. doi: 10.1177/03331024231187132.

  PMID: 37435807 DERIVED

MeSH Terms

Conditions

Facial Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Jorunn L Helbostad, PhD prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, double-blind, cross-over, placebo-controlled pilot study

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 12, 2018
• Study Start: May 1, 2018
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)