Post-traumatic headache Trials in Disease

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

This clinical trial is investigating whether botulinum toxin A can help patients who suffer from persistent headaches that began after a mild head injury. These headaches can last for a long time and cause significant discomfort, affecting daily life and overall well-being.

Who can participate:

• Adults between 18 and 80 years old who have been diagnosed with persistent post-traumatic headache
• Individuals who experience headaches on at least 15 days each month
• Those who have moderate to severe headaches on at least 8 days during the initial monitoring period
• Participants must be fluent in Danish

Who cannot participate:

• Patients with headaches unrelated to a past injury
• Those currently enrolled in another clinical trial
• Individuals who have had allergic reactions to botulinum toxin type A in the past
• Women who are pregnant, planning to become pregnant, or breastfeeding
• People with a history of drug or alcohol abuse within the past year
• Patients with uncontrolled psychiatric disorders or medical conditions that could make participation unsafe
• Those who have had major surgery or serious injury within the past month
• Individuals unable to follow study procedures or attend required visits

Study focus and approach:

The trial begins with a four-week baseline phase where participants track the frequency and severity of their headaches. This monitoring period helps establish each person's typical headache pattern before any treatment begins.

After the baseline phase, eligible participants are randomly assigned to receive either botulinum toxin A or a placebo. The treatment is given through subcutaneous injection, meaning it is injected just under the skin. Neither the participants nor the researchers know who receives the actual medication and who receives placebo during the study.

The main evaluation period occurs between weeks 5 and 8 of the study. During this time, researchers compare 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 headache days. A secondary evaluation continues from weeks 9 to 12, providing additional information about the treatment's effectiveness over time.

Throughout the study, participants are monitored for any side effects, changes in their use of headache medications, and the need for additional treatments. The trial also investigates whether certain biological markers in the body, called neuro-inflammatory biomarkers, can help predict how well the treatment will work for different individuals.

Investigational drug:

Botulinum toxin A is the medication being tested in this trial. This drug is commonly used to relax muscles and works by blocking the release of certain chemical messengers in the body. Researchers believe it may help reduce headache frequency either by decreasing muscle tension or by affecting the way pain signals are transmitted. In this study, the medication is being evaluated specifically for its ability to reduce the number of moderate to severe headache days in people with persistent post-traumatic headaches.