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Study on the Effectiveness of Botulinum Toxin A and Sodium Chloride for Patients with Trigeminal Neuralgia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and effectiveness of a treatment for trigeminal neuralgia, a condition that causes severe facial pain. The treatment being tested is botulinum toxin A, commonly known as Botox. Botox is a protein that, when injected, can help relax muscles and reduce pain. In this study, Botox will be compared to a placebo to see if it is more effective in relieving the pain associated with trigeminal neuralgia.

The purpose of the study is to determine if Botox can provide better pain relief than a placebo for patients suffering from trigeminal neuralgia. Participants in the study will receive injections of either Botox or a placebo. The study will monitor the participants over a period of time to assess changes in their pain levels and any side effects they may experience. The study will also look at certain biological markers in the body that might predict how well the treatment works.

Throughout the study, participants will be evaluated to see how their pain changes from the beginning to the end of the trial. The study will also explore whether there are differences in certain biological markers between those who respond well to the treatment and those who do not. This research aims to provide valuable insights into the potential benefits of using Botox for managing trigeminal neuralgia and to identify factors that might influence its effectiveness.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the active treatment, botulinum toxin A, and the other group will receive a placebo, which is an inactive substance. This process is called a double-blind study, meaning neither you nor the researchers will know which group you are in.

  2. Step 2

    Baseline phase

    During the baseline phase, which lasts from week -4 to -1, you will be asked to record your pain levels daily. This will help establish a baseline for comparison during the treatment phase. You must experience at least one pain episode per day with an intensity of 3 to 10 on a scale from 0 (no pain) to 10 (maximum pain imaginable).

  3. Step 3

    Treatment administration

    If you are in the group receiving the active treatment, you will receive an injection of botulinum toxin A under the skin. The injection will be prepared using sodium chloride as a solvent. The exact dosage and frequency will be determined by the study protocol.

  4. Step 4

    Evaluation period

    The evaluation period occurs from week 2 to 5. During this time, your response to the treatment will be closely monitored. You will continue to record your pain levels daily. The primary goal is to assess the proportion of responders, which means those who show a significant reduction in pain compared to the baseline phase.

  5. Step 5

    Follow-up assessments

    Additional assessments will be conducted from week 9 to 12 to evaluate the long-term effects of the treatment. You will be asked to continue recording your pain levels and any side effects you may experience.

  6. Step 6

    Final evaluation

    At the end of the trial, a final evaluation will be conducted to determine the overall effectiveness and safety of the treatment. This will include a review of your pain records and any changes in your condition.

Who can join the trial?

5 criteria

  • You must have a diagnosis of classical trigeminal neuralgia or idiopathic trigeminal neuralgia. These are specific types of facial pain conditions.
  • You must be between the ages of 18 and 85 years old.
  • You must experience pain at least once a day, with an average intensity of 3 to 10 on a scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable. This must have occurred during the last 4 weeks before starting the study.
  • During the initial phase of the study, you must continue to experience pain at least once a day, with an average intensity of 3 to 10 on the same 0 to 10 scale, to continue in the study.
  • You must be fluent in Danish.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with trigeminal neuralgia cannot participate. Trigeminal neuralgia is a condition that causes severe facial pain.
  • Patients who are under 18 years old or over 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship, cannot participate.
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Investigated drugs

Botulinum toxin A is a medication used in this clinical trial to treat trigeminal neuralgia, a condition that causes severe facial pain. It works by blocking nerve signals that cause muscles to contract, which can help reduce pain and discomfort. In this study, researchers are examining whether this medication is more effective than a placebo in relieving the symptoms of trigeminal neuralgia. Participants will receive injections of botulinum toxin A, and the effects on their pain levels will be closely monitored to determine its effectiveness.

What is already known about the treatment

Botulinum toxin A – Botulinum toxin A is administered through injections directly into the affected area. It is currently being studied for its effectiveness in treating trigeminal neuralgia, a condition characterized by severe facial pain. The main therapeutic indication for this medication is to alleviate pain associated with trigeminal neuralgia. At the molecular level, botulinum toxin A works by blocking the release of certain chemicals in the nerves that signal pain, effectively reducing pain sensations. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Trigeminal neuralgia – Trigeminal neuralgia is a chronic pain condition that affects the trigeminal nerve, which carries sensation from the face to the brain. It is characterized by sudden, severe, and stabbing pain, often triggered by activities such as eating, talking, or touching the face. The pain episodes can last from a few seconds to several minutes and may occur in quick succession. Over time, the frequency and intensity of the pain can increase, leading to more frequent and prolonged episodes. The condition can affect one or both sides of the face, though it typically affects only one side. As the disease progresses, the intervals between pain episodes may decrease, and the pain may become more constant.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504567-17-00Estimated enrolment80 patientsSponsorRegion Hovedstaden

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