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Study on the Safety and Effectiveness of Botulinum Toxin A for Patients with Persistent Post-Traumatic Headache

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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 effects of botulinum toxin A on patients who suffer from persistent post-traumatic headache. This type of headache occurs after a mild injury to the head and can last for a long time, causing significant discomfort. The study aims to determine if botulinum toxin A is safe and more effective than a placebo in reducing the number of days patients experience moderate to severe headaches.

Participants in the study will receive either botulinum toxin A or a placebo through a method called subcutaneous injection, which means the treatment is given under the skin. The study will observe the effects of the treatment over several weeks, specifically looking at changes in headache frequency from the start of the study to the end of the evaluation period. Additionally, the study will explore whether certain biological markers, known as neuro-inflammatory biomarkers, can predict how well the treatment works.

The trial will monitor participants for any side effects and changes in their headache patterns. The goal is to see if botulinum toxin A can significantly reduce the number of headache days compared to the baseline period before treatment begins. This research could provide valuable insights into managing persistent post-traumatic headaches and improving the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline phase

    During this phase, the frequency and severity of headaches are monitored. This period lasts for four weeks, from weeks -4 to -1.

    Participants must experience headaches on at least 15 days per month, with moderate-to-severe headaches on at least 8 days, to qualify for the next phase.

  2. Step 2

    Randomization and treatment phase

    Participants are randomly assigned to receive either botulinum toxin A (BTX-A) or a placebo. The treatment is administered subcutaneously, which means it is injected under the skin.

    The treatment phase begins after the baseline phase and continues for several weeks. The specific duration of treatment is not detailed in the provided information.

  3. Step 3

    Evaluation period

    The primary evaluation period occurs from weeks 5 to 8. During this time, the effectiveness of the treatment is assessed by comparing the number of moderate-to-severe headache days to the baseline period.

    A successful response is defined as a reduction of 30% or more in the number of days with moderate or severe headaches.

  4. Step 4

    Secondary evaluation period

    A secondary evaluation occurs from weeks 9 to 12. This period further assesses the treatment's effectiveness and any changes in inflammatory markers in the body.

    Additional assessments include changes in headache impact, psychological well-being, and sleep quality scores.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for any side effects, particularly between weeks 2 to 5.

    The study also tracks any increase in headache medication use or the need for additional treatments.

Who can join the trial?

5 criteria

  • Have a diagnosis of **persistent post-traumatic headache**. This means having ongoing headaches that started after a mild head injury.
  • Be between the ages of 18 and 80 years old.
  • Have headaches on at least 15 days each month during the last 4 weeks before starting the study.
  • During the initial phase of the study, experience moderate-to-severe headaches on at least 8 days and have headaches on at least 15 days to move to the treatment phase.
  • Be fluent in Danish.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of headache that is not related to a past injury.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had an allergic reaction to **botulinum toxin type A** in the past. This is a substance used in the study to help with headaches.
  • Patients who have a medical condition that the study doctors think might make it unsafe for them to participate.
  • Patients who are pregnant or planning to become pregnant during the study period.
  • Patients who are breastfeeding.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have a significant psychiatric disorder that is not well controlled. This means a mental health condition that might affect their ability to participate in the study.
  • Patients who have had major surgery or a serious injury within the past month.
  • Patients who are unable to comply with the study procedures, meaning they cannot follow the study rules or attend the required visits.
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Investigated drugs

Botulinum Toxin A is being studied in this trial to see if it can safely and effectively reduce the number of moderate-to-severe headache days in patients who suffer from posttraumatic headaches. This medication is commonly used to relax muscles and is being tested to determine if it can help alleviate headache symptoms by reducing muscle tension or affecting pain pathways.

What is already known about the treatment

Botulinum Toxin A – This medication is administered through injections, typically into specific muscles or areas of the body. It is currently being studied for its effectiveness in treating persistent post-traumatic headaches. The main therapeutic indication is to reduce the frequency of moderate-to-severe headache days. At the molecular level, Botulinum Toxin A works by blocking the release of certain neurotransmitters, which helps to relax muscles and reduce pain signals. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Persistent Post-Traumatic Headache – This condition occurs after a head injury and is characterized by headaches that persist for a long time following the trauma. The headaches can vary in intensity and may be similar to tension-type headaches or migraines. They often begin within seven days of the injury or after regaining consciousness. The pain can be constant or intermittent and may be accompanied by symptoms such as dizziness, fatigue, or difficulty concentrating. Over time, the frequency and severity of the headaches can change, potentially impacting daily activities and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515901-24-00Protocol codePTH BotoxEstimated enrolment80 patientsSponsorRegion Hovedstaden

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