LSD to Improve Cluster Headache Impact Trial
ConditionChronic Cluster Headache
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-75
SponsorRadboud University Medical Center
About this trial
This study aims to investigate the efficacy and safety of LSD 25μg every 3 days for 3 weeks versus placebo in the treatment of chronic cluster headache (cCH).
It is a 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by a 5-week post-treatment observation period.
Primary objective: to evaluate the efficacy of LSD 25μg every 3 days for 3 weeks in cCH.
Additional objectives:
* To evaluate the safety of LSD 25μg every 3 days for 3 weeks in cCH. * To explore the exposure-response relationship of 25μg LSD in cCH. * To explore cost-effectiveness of treatment with LSD in cCH. * To evaluate the efficacy of LSD on health-related quality of life.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- LSD tartrate
- Placebo
Treatment groups
65 Participants
are divided into 2 treatment groupsSponsors and collaborators
Radboud University Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Canisius-Wilhelmina Hospital
Collaborator
Leiden University Medical Center
Collaborator
Source ClinicalTrials.gov