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Study on Botulinum Toxin Type A and Sodium Chloride for Patients with Treatment-Resistant Chronic Cluster 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 a treatment for chronic cluster headache, a severe type of headache that occurs in cyclical patterns or clusters. The study is investigating the use of Botulinum toxin type A, commonly known as Botox, which is a protein used in various medical treatments. The aim is to determine how effective this treatment is when directed at a specific area in the head called the sphenopalatine ganglion, which is a group of nerve cells linked to headache pain. The treatment will be administered using a special device that helps guide the injection to the right spot.

Participants in the study will receive either the active treatment with Botulinum toxin type A or a placebo. The study will monitor changes in the frequency and intensity of headache attacks over a period of time. The goal is to see if the treatment can reduce the number of headache attacks and improve the quality of life for those suffering from chronic cluster headaches. The study will also compare the occurrence of any side effects between those receiving the active treatment and those receiving the placebo.

The study will take place over several weeks, with participants being closely monitored by healthcare professionals. The results will help determine if Botulinum toxin type A is a viable treatment option for people who have not found relief from other medications. This research could provide new insights into managing chronic cluster headaches and offer hope for those affected by this challenging 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

    Joining the study

    Upon joining the study, consent is required. This involves understanding the study procedures and agreeing to comply with them throughout the study duration.

    Eligibility includes being between 18 and 85 years old, having chronic cluster headaches, and experiencing a certain frequency of headache attacks.

  2. Step 2

    Baseline period

    During the baseline period, the frequency of headache attacks is recorded. This helps establish a comparison point for later stages of the study.

    Participants must maintain their current headache medication regimen without changes in type, frequency, or dose.

  3. Step 3

    Treatment administration

    The treatment involves an injection of botulinum toxin type A towards the sphenopalatine ganglion. This is done using an image-guided surgical device.

    The injection is administered as a solution for injection.

  4. Step 4

    Post-treatment observation

    The primary observation period occurs between weeks 5 and 8 after the treatment. The number of headache attacks is monitored and compared to the baseline period.

    Secondary observations continue from weeks 9 to 12, focusing on changes in attack frequency and intensity.

  5. Step 5

    Evaluation of results

    The study evaluates the difference in the number of headache attacks and their intensity between the treatment and placebo groups.

    The effectiveness of the treatment is assessed by the reduction in attack frequency and intensity.

Who can join the trial?

10 criteria

  • Provide informed and written consent, which means you agree to participate and understand what the study involves.
  • Be able to understand the study procedures and follow them for the entire length of the study.
  • Be a male or female between 18 and 85 years old.
  • Have headache attacks that meet the criteria for **chronic cluster headache** according to the International Classification of Headache Disorders (ICHD) III.
  • Experience most of your headache attacks (at least 80%) on one side of your head.
  • Report having an average of at least 4 cluster headache attacks per week on the side where you usually get headaches, both in the 3 months before joining the study and during the baseline period.
  • Have a condition that is **pharmacologically refractory**, meaning that medications like verapamil, lithium, or suboccipital steroid injections do not work well for you, cause bad side effects, or you cannot take them for some reason.
  • Agree to keep taking your current preventive headache medications without changing the type, frequency, or dose during the study.
  • Be able to tell the difference between cluster headaches and any other types of headaches you might have.
  • If you are a woman who can have children, you must use highly effective birth control for 4 weeks after receiving the injection.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of chronic cluster headache cannot participate. This is a type of headache that occurs in patterns or clusters.
  • Participants must be within the specified age range, which typically includes adults. If you are outside this age range, you cannot join the study.
  • Both males and females are eligible, but if you do not identify as either, you may not be able to participate.
  • If you belong to a vulnerable population, which means you might need special protection or care, you may not be eligible for the study.
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Investigated drugs

Botulinum toxin type A is being studied for its potential to help people with chronic cluster headaches that do not respond to other treatments. In this trial, the botulinum toxin is used to block the sphenopalatine ganglion, a group of nerves associated with headache pain. The procedure is done with the help of a special device that guides the treatment to the right spot.

What is already known about the treatment

Botulinum Toxin Type A – This medication is administered through an injection, specifically targeting the sphenopalatine ganglion using an image-guided surgical device. It is currently being studied in clinical trials for its effectiveness in treating chronic cluster headaches that do not respond to other treatments. The main therapeutic indication is for chronic cluster headaches, a severe form of headache. At the molecular level, Botulinum Toxin Type A works by blocking the release of certain neurotransmitters, which helps reduce muscle contractions and pain signals. It is classified pharmacologically as a neurotoxin.

Investigated diseases

Chronic Cluster Headache – Chronic cluster headache is a neurological condition characterized by severe, recurring headaches that typically occur in cyclical patterns or clusters. These headaches are often described as intense, burning, or piercing pain, usually located around one eye or on one side of the head. The attacks can last from 15 minutes to three hours and may occur several times a day. During a cluster period, which can last weeks or months, individuals may experience daily attacks, followed by periods of remission when headaches stop completely. The exact cause of chronic cluster headaches is not fully understood, but they are believed to involve abnormalities in the hypothalamus, a part of the brain. Environmental factors and certain triggers, such as alcohol or strong smells, may also play a role in triggering attacks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515166-14-00Protocol codeBASICstudyEstimated enrolment70 patientsSponsorNorwegian University Of Science And Technolology

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