Cluster headache
Chronicle
What does the study entail?
In order to participate in this study, you must be able to speak and read Dutch fluently.
An interventional, open-label, fixed-dose and multiple administration study to evaluate long-term treatment with Eptinezumab in patients with chronic cluster headache.
This study is a 1-year study to gather information on prolonged exposure to Eptinezumab in patients with chronic cluster headache (cCH). In this study, we look at the long-term safety and tolerability of Eptinezumab in patients with chronic cluster headache. The study drug will be administered by infusion.
What does the study entail?
The study will be conducted at the Brain Research Center Amsterdam.
During a period of about 60 weeks, you will visit the study site approximately 7 times and 8 telephone appointments will be conducted. Each study visit to the study site will last about three to four hours, depending on the procedures performed during that visit. You will need to fast (no food or drink, except water) before some blood tests. In addition, you will need to complete a daily digital headache diary to provide information about the severity of the pain associated with your cluster headache and any medications you have taken to relieve your cluster headache.
Screening – selection
During a period of up to four weeks, it will be determined whether you meet the study criteria and whether your overall health allows participation in the study. If this is the case, you can participate. The selection takes place at our site in Amsterdam and includes checking your medical history, blood tests, a physical and a neurological examination, an ECG examination, and questionnaires. In addition, multiple questionnaires will be completed and it is important that you keep a daily headache diary.
Treatment
The treatment phase lasts 48 weeks. This study is an open-label study, which means that you will be given the study drug. In total, there are 4 infusion administrations. During these visits, safety evaluations will be performed before and after the infusion. These safety evaluations will include measurement of vital signs, asking about concomitant medication and adverse events, an ECG examination, a blood draw, and a physical and neurological examination. During the telephone appointments, questionnaires will be handled, and questions will be asked about adverse events and concomitant medication.
Follow-up
After completing the treatment phase, a final on-site visit will take place in week 56. Vital signs, a blood draw, physical and neurological examinations, and an ECG will be taken at this visit.
Who can participate?
- You have a diagnosis of chronic cluster headache.
- You are between 18 and 75 years of age.
- You can keep a daily digital headache diary.
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