Facial PainPhase 2NCT03462290
Botox Injections for Patients With Persistent Facial Pain
A Phase 2 study testing botulinum toxin type A in people with Facial Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Facial Pain
- What is being tested?
- botulinum toxin type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2018to 23 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- Facial and/or oral pain fulfilling criteria B and C.
- Recurring daily for >2 hr per day for >3 months
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Neuroscience, Faculty of Medicine and Health Science, NTNU
Trondheim
About this study
Official title: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Patients With Persistent Idiopathic Facial Pain: a Randomized, Double-blind, Cross- Over, Placebo-controlled Pilot Study
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
- Being tested
- botulinum toxin type A, placebo
- Keywords
- Botulinum Toxins, Type A, Injections, Sphenopalatine Ganglion Block
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called botox
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
placeboDrug
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin | Experimental | Not described Receives: Drug: botulinum toxin type A; Drug: placebo |
| placebo | Placebo comparator | Not described Receives: Drug: botulinum toxin type A; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5-8 weeks
Secondary outcomes (7)
Percentage of patients with pain intensity rating 1-3 (mild pain)
Measured: 8 weeks
Physical functioning assessed by a Multidimensional Pain Inventory or Brief Pain Inventory interference scale
the total range of the scale is 10, ranging from 0-10 where 0 is no pain and 10 is worst pain imaginable. No subscale. The higher values the worse outcome.
Measured: 8 weeks
Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS)
Measured: 8 weeks
Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC)
Measured: 8 weeks
Number of days without persistent idiopathic facial pain
Measured: 8 weeks
number of doses of analgesics per 4 weeks
Measured: 8 weeks
Sick leave due to persistent idiopathic facial pain
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 May 2018
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facial PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, double-blind, cross-over, placebo-controlled pilot study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Jorunn L Helbostad, PhD prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462290
- Sponsor's protocol ID
- 010817-0
- Other IDs
- 2017-002518-30, 2017
- Status last verified
- Dec 2021
- First submitted
- 26 Feb 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37435807
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Patients With Persistent Idiopathic Facial Pain: a Randomized, Double-blind, Cross- Over, Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03462290
- Acronym / sponsor ID
- 010817-0
- Conditions
- Facial Pain
- Keywords
- Botulinum Toxins, Type A, Injections, Sphenopalatine Ganglion Block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a randomized, double-blind, cross-over, placebo-controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin | Experimental | Drug: botulinum toxin type A, Drug: placebo |
| placebo | Placebo comparator | Drug: botulinum toxin type A, Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin type AAlso: botoxBotulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide | Drug | Botulinum toxin, placebo |
| placebosolution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide | Drug | Botulinum toxin, placebo |
Primary outcome
Changes from baseline to weeks 5-8 in Numeric Pain Rating Scale (NRS) score for persistent idiopathic facial pain (PIFP)
Time frame: 5-8 weeks
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
7 secondary outcomes
Percentage of patients with pain intensity rating 1-3 (mild pain)
Time frame: 8 weeks
Physical functioning assessed by a Multidimensional Pain Inventory or Brief Pain Inventory interference scale
Time frame: 8 weeks
Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS)
Time frame: 8 weeks
Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC)
Time frame: 8 weeks
Number of days without persistent idiopathic facial pain
Time frame: 8 weeks
number of doses of analgesics per 4 weeks
Time frame: 8 weeks
Sick leave due to persistent idiopathic facial pain
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Derived from this study: PubMed 37435807Jamtoy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorunn L Helbostad, PhD prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing botulinum toxin type A in people with Facial Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline to weeks 5-8 in Numeric Pain Rating Scale (NRS) score for persistent idiopathic facial pain (PIFP) (time frame: 5-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.