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Safety and efficacy of botulinum toxin A (Botox) in patients with trigeminal neuralgia
EU CTIS ID: 2023-504567-17-00
What this study is testing
To investigate if botulinum toxin A is more effective than placebo in the treatment of trigeminal neuralgia.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A diagnosis of classical trigeminal neuralgia or idiopathic trigeminal neuralgia according to criteria of The International Classification of Headache Disorders 3rd edition.
- Age between 18 and 85 years
- Subjects must experience pain defined as minimum one TN related pain paroxysm per day of an average intensity of 3 to 10, inclusive, on the 11-point NRS (0 = no pain; 10 = maximum pain imaginable) during the last 4 weeks to enter the baseline phase.
- During baseline phase subjects must experience pain defined as minimum one TN related pain paroxysm per day of an average intensity of 3 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) to be randomized.
- Fluency in Danish
You likely can't join if
- Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.
- Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge
- Ongoing and unstable severe psychiatric disease.
- Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.
- Change of trigeminal neuralgia treatment or treatment dose within two weeks prior to the baseline visit.
- Previous treatment with botulinum toxin A for facial pain.
See the full eligibility criteria
- A diagnosis of classical trigeminal neuralgia or idiopathic trigeminal neuralgia according to criteria of The International Classification of Headache Disorders 3rd edition.
- Age between 18 and 85 years
- Subjects must experience pain defined as minimum one TN related pain paroxysm per day of an average intensity of 3 to 10, inclusive, on the 11-point NRS (0 = no pain; 10 = maximum pain imaginable) during the last 4 weeks to enter the baseline phase.
- During baseline phase subjects must experience pain defined as minimum one TN related pain paroxysm per day of an average intensity of 3 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) to be randomized.
- Fluency in Danish
- Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.
- Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge
- Ongoing and unstable severe psychiatric disease.
- Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.
- Change of trigeminal neuralgia treatment or treatment dose within two weeks prior to the baseline visit.
- Previous treatment with botulinum toxin A for facial pain.
- Loading treatment within 4 weeks with phenytoin or sodium valproate.
- Female subjects either pregnant, breastfeeding or with planned conception within the study period.
- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study (see protocol for acceptable methods).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.