Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LSD tartrate

    Drug

    LSD tartrate equivalent to 25 microgram LSD base

  • Placebo

    Drug

    Placebo with equal appearance

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: VerumExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in weekly attack frequency, across treatments groups.

In week 3 post-randomization, compared to the 4-week baseline average per week

Time frame
week 3 of treatment

Secondary outcomes

1

Mean change in weekly attack frequency across weeks 4-8 compared to the 4-week baseline and for each week separately.

Time frame
week 8 post-randomization
2

100% reduction (remission rate) in number of weekly attacks in the third treatment week, compared to the 4-week baseline, across treatment groups.

Rate of subjects with 100% reduction in weekly attack frequency compared to baseline

Time frame
week 3 post-randomization
3

≥50% reduction (50% responder rate) in number of weekly attacks in the third treatment week, compared to the 4-week baseline, across treatment groups.

Rate of subjects with more than 50% reduction in weekly attack frequency compared to baseline

Time frame
week 3 post-randomization
4

≥30% reduction (30% responder rate) in number of weekly attacks in the third treatment week, compared to the 4-week baseline, across treatment groups.

Rate of subjects with more than 30% reduction in weekly attack frequency compared to baseline

Time frame
week 3 post-randomization

Other outcomes

1

Alcohol consumption

Units of alcohol consumed during baseline, treatment and follow-up

Time frame
during the entire 12-week duration of the study
2

PK-PD modelling

Correlation between individual pharmacokinetics of LSD and relative change of weekly attack frequency

Time frame
Week 1 and 3

Sponsors and contacts

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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
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