Using LSD to treat chronic cluster headaches

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of administering 25μg of LSD every three days for three weeks to patients suffering from chronic cluster headaches, compared to a placebo. The study includes a four-week baseline observation period followed by a five-week post-treatment observation phase. The primary objective is to evaluate how effective LSD is in reducing headache frequency and severity, while also assessing its safety and potential impact on patients' quality of life. The trial aims to address the significant unmet need for better-tolerated and effective treatments for chronic cluster headaches.

Why it matters

Who can join: the full rules

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

Where it's running

• Leiden University Medical Center (LUMC)
  Leiden, Netherlands Recruiting
• Canisius-Wilhelmina Ziekenhuis (CWZ)
  Nijmegen, Netherlands Recruiting

Study contacts

• Principal investigator: Kees Kramers, Prof. — Radboud University Medical Center
• Study coordinator: Julia Jansen, MD
• Email: julia.jansen@cwz.nl
• Phone: +31 24 3658765

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.