A phase 3 randomized, placebo-controlled, triple blind parallel-group study of candesartan in adults with episodic cluster headache (Episodic CandClus2)
This study is looking into a medicine called candesartan for adults who experience episodic cluster headaches. These are very painful, short-term headaches that come in cycles. Researchers want to see if candesartan can reduce how often severe or very severe cluster headache attacks happen. Some participants will receive the active medicine, while others will get a 'dummy' tablet (placebo) that looks the same. The main goal is to compare how many severe headaches people have each week while taking either the medicine or the placebo. The study also looks at how the medicine affects overall headache frequency, intensity, and how people feel about their improvement and quality of life.
At a glance
What is this study about?
This study is about finding a better way to help people who suffer from a condition called episodic cluster headache. These headaches are known for being extremely painful and can occur in cycles for weeks or months at a time, followed by periods of remission. The medicine being tested is called candesartan. Researchers are trying to see if this medicine can help reduce how often people get these severe headaches and how intense they are.
To find this out, the study will compare candesartan with a 'dummy' tablet, known as a placebo. This means some people will get the active medicine, and others will get a tablet that looks exactly the same but contains no medicine. Neither the participants nor the doctors will know who is getting which, so everyone's experience is measured fairly. The main thing they want to measure is how much the weekly number of severe or very severe headaches changes for people while they are taking the treatment.
Beyond just counting headaches, the study also looks at many other important things. For example, it will check if people have fewer headaches overall, if the headaches are less painful, and if people feel better in their daily lives. They will also look at how much other medicines or oxygen treatments people need for their attacks. The aim is to gather a full picture of how candesartan might help people manage this very difficult condition.
Key takeaways
- The study tests if candesartan can reduce severe cluster headaches.
- It's for adults with episodic cluster headaches.
- Some participants get active medicine, some get a 'dummy' tablet (placebo).
- Participation involves taking tablets and keeping a headache diary.
- Your health and headache changes will be closely monitored.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults who experience episodic cluster headaches. This means you have periods where you get cluster headaches, followed by periods where you don't. You need to be at least 18 years old to take part.
There might be other health conditions or medicines you are taking that mean you can't join the study. This is to make sure the study is safe for everyone involved and that the results are clear. The study team will check all your details carefully to see if it's the right fit for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you get episodic cluster headaches (headaches that come in cycles)?
- Are you able to attend appointments and keep a headache diary?
- Are you willing for your doctors to know which treatment you are getting (even if you don't)?
- Are you generally in good health other than your cluster headaches?
What does participation involve?
If you join this study, you will be given study tablets to take. Some will be the active medicine, candesartan, and others will be a dummy tablet (placebo). Neither you nor your study doctor will know which you are taking. You'll need to keep a diary to record your headaches and how severe they are, especially during a three-week main treatment period.
You will have several appointments at the clinic over about 14 weeks. These visits will involve health checks, asking about your headaches, and how you are feeling generally, including your mood and how your headaches impact your daily life. You might also be asked about any other medicines you are taking. There will be follow-up throughout the study period.
Potential risks and benefits
Locations (2)
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- —UnverifiedNorway
Common questions
What are episodic cluster headaches?
Episodic cluster headaches are very severe headaches that happen in cycles. You get attacks frequently for a period (e.g., weeks or months), and then you have a period without them.
What is candesartan?
Candesartan is a medicine that is being tested in this study to see if it can help reduce the frequency and severity of cluster headaches.
What is a 'placebo'?
A placebo is a 'dummy' tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects accurately.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor the study doctors will know whether you are receiving the active medicine or the placebo. This is to ensure the study is fair and unbiased.
How long will the study last for me?
The main part of the study involves a three-week treatment phase, but you will have check-ups and follow-up visits over a total period of about 14 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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