Ongoing Clinical Trials for Trigeminal Neuralgia
Currently, there are 2 ongoing clinical trials investigating new treatment options for trigeminal neuralgia, a chronic condition causing severe facial pain. These studies are testing different medications, including botulinum toxin A and basimglurant, to help patients who have not found sufficient relief from existing treatments. Trials are taking place across multiple European countries, offering potential new approaches to managing this debilitating condition.
Clinical trial locations
- Denmark
- Germany
- Italy
- Poland
- Spain
Study on the Effectiveness of Botulinum Toxin A and Sodium Chloride for Patients with Trigeminal Neuralgia
This trial is investigating whether botulinum toxin A, commonly known as Botox, can provide effective pain relief for people suffering from the severe facial pain caused by this condition. The study compares the effects of Botox injections to a placebo to determine if the active treatment offers superior pain management.
Main inclusion criteria: To participate in this study, you must have a confirmed diagnosis of classical or idiopathic trigeminal neuralgia. You need to be between 18 and 85 years old and experience pain at least once daily with an intensity of 3 to 10 on a pain scale (where 0 is no pain and 10 is the worst imaginable pain) during the four weeks before the study begins. This pattern of pain must continue during the initial baseline phase to remain eligible. You must also be fluent in Danish, as the study is conducted in Denmark.
Main exclusion criteria: You cannot participate if you do not have a diagnosis of trigeminal neuralgia, are under 18 or over 65 years old, or belong to a vulnerable population that cannot provide proper consent or is in a dependent relationship.
Focus and goal: The study aims to determine whether Botox can provide better pain relief than a placebo for patients with this painful condition. The research also seeks to identify biological markers that might predict how well the treatment works for different individuals. The trial follows a double-blind design, meaning neither participants nor researchers know who receives the active treatment or placebo during the study period.
Investigational drug: The medication being tested is botulinum toxin A, which works by blocking nerve signals that cause muscles to contract. When injected under the skin, it may help reduce pain and discomfort. Researchers will monitor participants over time to assess changes in pain levels and identify any side effects.
Study on Basimglurant for Treating Pain in Patients with Trigeminal Neuralgia
This international study is testing a medication called basimglurant for people who have not achieved sufficient pain relief from their current treatments. The trial takes place across multiple European countries, including Germany, Spain, Italy, Denmark, and Poland. It includes several phases to evaluate both the short-term effectiveness and long-term safety of this oral medication.
Main inclusion criteria: Eligible participants must be between 18 and 75 years old with a confirmed diagnosis of primary trigeminal neuralgia verified by a study neurologist. You need to experience at least three pain episodes per day, each with an intensity of 4 or higher on a pain scale, during the last seven days. You must be able and willing to provide written informed consent and follow study procedures. Female participants must either be sterile or menopausal, or if of childbearing potential, must not be pregnant or breastfeeding and must use appropriate birth control methods. You must be fluent in the language used by the study team and in the informed consent documents.
Main exclusion criteria: You cannot participate if you have other significant medical conditions that could interfere with the study, are currently taking medications that might affect study results, have a history of allergic reactions to the study medication or similar drugs, are pregnant or breastfeeding, have participated in another clinical trial within the last 30 days, have a history of drug or alcohol abuse, have mental health conditions that might affect your participation, or are unable to comply with study procedures.
Focus and goal: The study evaluates whether basimglurant can effectively reduce pain and maintain pain relief over time. It consists of three main phases: an initial 8-week run-in phase where all participants receive the medication, a 12-week double-blind phase where participants receive either basimglurant or placebo without knowing which, and a 52-week open-label extension where all participants receive the active medication to assess long-term safety. Throughout the study, participants keep pain diaries and undergo regular health assessments.
Investigational drug: Basimglurant is taken orally as a daily capsule, with doses ranging from 1.5 to 3.5 mg. It works by targeting specific receptors in the brain to help reduce pain signals. This medication is being studied specifically for its potential to help patients whose pain has not responded adequately to existing treatments.
Summary
The two ongoing clinical trials for trigeminal neuralgia represent different approaches to managing this severe facial pain condition. One study focuses on botulinum toxin A injections conducted exclusively in Denmark, while the other investigates an oral medication, basimglurant, across five European countries, suggesting a broader international research effort. Both trials target patients experiencing significant daily pain and aim to provide options for those who have not found adequate relief with current treatments. The basimglurant study offers a particularly extensive evaluation period, including a 52-week long-term safety assessment, while the botulinum toxin study explores biological markers that might predict treatment response. Together, these trials reflect ongoing efforts to expand treatment options and improve quality of life for people living with this challenging condition.
