Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT04179266
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Age between 18 and 60 years
* Diagnose: Chronic cluster headache according to ICHD-3 criteria (1)
* Body weight ≥50 kg and BMI ≤30
Exclusion Criteria:
* Conditions that result in the participant being unable to complete the experiment
* Medical history with elevated intraocular pressure (e.g. glaucoma)
* Medical history with severe heart or liver disease
* Aneurysmal vascular disease or arteriovenous malformations
* Medical history with severe neurological disease except of headache
* BP measured at baseline before CH attack (Systolic\> 140 mmHg or / and diastolic blood pressure\> 90 mm Hg)
* Medical history with severe depression or psychosis
* A previous history of drug abuse
* Consumption of illegal drugs within the last 6 months
* Medical history of nasal abnormality or dysfunction (e.g. rhinitis)
* High disposition for larynges or apnea
* Positive pregnancy test before treatment and breastfeeding
* Known hypersensitivity to ketamine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04179266
Study Brief:
Protocol Section:
NCT04179266