A Phase 2 interventional study of botulinum toxin type A and placebo in Facial Pain, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-17.
Sponsored by Norwegian University of Science and Technology · Phase 2, Interventional, and Treatment
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
182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 132 interventional studies indexed under Facial Pain.
Browse Facial Pain studies →Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: botulinum toxin type A · Drug: placebo
Drug: botulinum toxin type A · Drug: placebo
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
Also known as: botox
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
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
Time frame: 5-8 weeks
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
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.
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
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Nov 2021, 42 months.
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Norwegian University of Science and Technology →