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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT05477459
Eligibility Criteria:
Inclusion Criteria:
* CCH according to the International Classification of Headache Disorders version 3 (ICHD-3)
* At screening: stable weekly attack frequency in the 4 weeks prior to screening (assessed retrospectively), averaging at least 8 per week and each week within a 40% window around the average
* At randomization: average of at least 8 attacks per week and no absence of attacks on more than two consecutive days during baseline
Exclusion Criteria:
* Use of excluded concomitant treatment at screening (lithium; other prophylactics if not on a stable dose for less than one month; steroids/GON block within 2 months before screening; sphenopalatinum block, neurostimulation (changed setting within 3 months before screening) or botulinum toxin within 3 months before screening) and during the double-blind phase
* Use of LSD(-derivatives) (other than investigational drug), psilocybin, ketamine or cannabis within 3 months prior to screening and throughout the study
* Lifetime and/or family history (first degree relatives) of psychotic or bipolar disorder, suicidal intention or attempt
* A score of 6 or more on the 'Ervaringenlijst' (PQ-16) to exclude subclinical susceptibility to psychosis
* Actual abuse of alcohol and/or recreational drugs
* Lifetime history of cardiac valvular disease
* History or evidence of cognitive disorder at screening
* Positive urine drug screen at screening
* Females: Pregnancy, lactation, no acceptable contraceptive use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
75 Years
Study:
NCT05477459
Study Brief:
Protocol Section:
NCT05477459