Chronic Cluster HeadachePhase 2LICITNCT05477459
LSD to Improve Cluster Headache Impact Trial
A Phase 2 study testing LSD tartrate in people with Chronic Cluster Headache, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Chronic Cluster Headache
- What is being tested?
- LSD tartrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 Apr 2025to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History or evidence of cognitive disorder at screening
- Positive urine drug screen at screening
- Females: Pregnancy, lactation, no acceptable contraceptive use
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Center (LUMC)
Leiden
Martien van Liefland, 071 526 21 11, LICIT@LUMC.nl
Rolf Fronczek, MD, PhD
- Recruiting
Canisius-Wilhelmina Ziekenhuis (CWZ)
Nijmegen
Julia Jansen, 024 365 82 10, LICIT@cwz.nl
Willemijn Leen, MD, PhD
About this study
Official title: Efficacy and Safety of Minidosing Lysergic Acid Diethylamide (LSD) for Chronic Cluster Headache: a Randomized Placebo-controlled Study
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.
Read more
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.
Read the detailed description
Treatment of cluster headache consists of acute remedies for attacks (mainly 100% O2, sumatriptan), transitional treatment for temporary frequency reduction (subcutaneous steroid injection at the greater occipital nerve (GON block), oral steroids or frovatriptan) and prolonged prophylaxis (e.g. verapamil, lithium, topiramate). Although the latter compounds have shown some efficacy in reducing the attack frequency, the evidence for their effect is weak. All current prophylactics are prescribed off-label and are limited in their utility due to associated side effects. Despite treatment, many (notably chronic) cluster headache patients continue suffering headache attacks.
Invasive, expensive treatments like hypothalamic deep brain stimulation, occipital nerve stimulation and sphenopalatine ganglion stimulation are last resort options. Recently, a monoclonal antibody targeting calcitonin gene related peptide (CGRP) received FDA approval for episodic cluster headache, but was shown to be ineffective in cCH. Thus, there is a considerable unmet need for effective treatments that are better tolerated, safe and affordable.
In this study, the investigators will assess the efficacy of prophylactic treatment with LSD in cCH. The evidence for the efficacy of LSD is limited, with the majority of data originating from case reports or uncontrolled and retrospective (internet) surveys. Nevertheless, these studies do provide indications that LSD may hold potential as a cluster headache prophylaxis.
The primary objective of this randomized double-blind placebo-controlled trial is to compare the efficacy of LSD 25μg every 3 days for 3 weeks versus placebo in cCH. The investigators aim to show that, at the end of treatment, verum is more efficacious than placebo with comparable tolerability in an ambulatory setting. To explore the sustainability of benefit the investigators will also assess the (sustained) response at 5 weeks post-treatment (8 weeks postrandomization).
If the study findings are positive, LSD should be further studied before use in routine clinical practice. Non-hallucinogenic low-dosed LSD may provide an alternative or adjunctive option for patients who do not respond to or cannot tolerate currently available treatments.
- Conditions
- Chronic Cluster Headache
- Being tested
- LSD tartrate, Placebo
- Keywords
- Chronic cluster headache, Lysergic acid diethylamide
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSD tartrateDrug
Also called Lysergic acid diethylamide
LSD tartrate equivalent to 25 microgram LSD base
PlaceboDrug
Placebo with equal appearance
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Lysergic diethylamide tartrate (equivalent to 25 microgram LSD base), one dose every 3 days for 3 weeks (totalling 7 vials) Receives: Drug: LSD tartrate |
| Placebo | Placebo comparator | Placebo vial looking like verum vial, one vial every 3 days for 3 weeks (totalling 7 vials) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in weekly attack frequency, across treatments groups.
In week 3 post-randomization, compared to the 4-week baseline average per week
Measured: week 3 of treatment
Secondary outcomes (22)
Mean change in weekly attack frequency across weeks 4-8 compared to the 4-week baseline and for each week separately.
Measured: week 8 post-randomization
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
Measured: week 3 post-randomization
≥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
Measured: week 3 post-randomization
≥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
Measured: week 3 post-randomization
100% reduction (remission rate) in number of weekly attacks across weeks 4-8 compared to the 4-week baseline and for each week separately.
Rate of subjects with 100% reduction in weekly attack frequency compared to baseline
Measured: week 8 post-randomization
≥50% reduction (50% responder rate) in number of weekly attacks across weeks 4-8 compared to the 4-week baseline and for each week separately.
Rate of subjects with 50% reduction in weekly attack frequency compared to baseline
Measured: week 8 post-randomization
≥30% reduction (30% responder rate) in number of weekly attacks across weeks 4-8 compared to the 4-week baseline and for each week separately.
Rate of subjects with 30% reduction in weekly attack frequency compared to baseline
Measured: week 8 post-randomization
Mean change in weekly attack frequency in the entire 3 week treatment period compared to the 4-week baseline.
Measured: week 3 post-randomization
Mean change in mean headache attack duration (minutes) per week, across treatment groups
In week 3 compared to the weekly average during 4-week baseline
Measured: week 3 post-randomization
Mean change in mean headache attack duration (minutes) per week, across treatment groups
Across weeks 4-8 compared to the 4-week baseline and for each week separately.
Measured: week 8 post-randomization
Mean change in mean headache attack severity (VAS 1-10), across treatment groups
In week 3 compared to the weekly average during 4-week baseline
Measured: week 3 post-randomization
Mean change in mean headache attack severity (VAS 1-10), across treatment groups
Across weeks 4-8 compared to the 4-week baseline and for each week separately.
Measured: week 8 post-randomization
Mean change in number of abortive medication use, across treatment groups
In week 3 compared to the weekly average during 4-week baseline
Measured: week 3 post-randomization
Mean change in number of abortive medication use, across treatment groups
Across weeks 4-8 compared to the 4-week baseline
Measured: week 8 post-randomization
Failure of sustained response'
Time to initiation of additional prophylactic treatment and/or GON-block during weeks 4-8, across treatment groups
Measured: Weeks 4-8 post-randomization
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change at week 3 post-randomization; scale 0-7, higher scores representing better improvement
Measured: Day 21 post-randomization
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change at week 8 post-randomization; scale 0-7, higher scores representing better improvement
Measured: weeks 3 and 8
Health-related quality of life
Change from baseline in EQ-5D-5L Visual Analogue Scale (VAS) at weeks 3 and 8.
Measured: weeks 3 and 8
Hospital Anxiety and Depression Score (HADS)
Change from baseline in Hospital Anxiety and Depression Scale (HADS) at weeks 3 and 8.
Measured: weeks 3 and 8.
Pharmacokinetic (PK)-pharmacodynamic (PD) modelling
Plasma LSD concentrations on day 18 post-randomization frequency
Measured: Day 18 post-randomization
Cost-effectiveness analysis (CEA) from a societal perspective comparing the LSD intervention with usual care.
Healthcare use and productivity losses will be measured by patient questionnaires (iMCQ, and iPCQ)
Measured: Week 1, 3 and 8
Efficacy of treatment masking
measured as perceived treatment assignment on a 5-point scale (likely verum/possibly verum/don't know/possibly placebo/likely placebo).
Measured: Week 1 and 3 post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start16 Apr 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by 5 weeks post-treatment observation period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Canisius-Wilhelmina Hospital, Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Kees Kramers, Prof., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477459
- Sponsor's protocol ID
- 131-2022
- Acronym
- LICIT
- Status last verified
- Mar 2025
- First submitted
- 5 Jul 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data underlying publication, after deidentification, will be shared upon request to the corresponding author
Publications
Hoffmann J, May A. Diagnosis, pathophysiology, and management of cluster headache. Lancet Neurol. 2018 Jan;17(1):75-83. doi: 10.1016/S1474-4422(17)30405-2. Epub 2017 Nov 23.
PubMed 29174963Rozen TD, Fishman RS. Cluster headache in the United States of America: demographics, clinical characteristics, triggers, suicidality, and personal burden. Headache. 2012 Jan;52(1):99-113. doi: 10.1111/j.1526-4610.2011.02028.x. Epub 2011 Nov 11.
PubMed 22077141Tepper SJ, Stillman MJ. Cluster headache: potential options for medically refractory patients (when all else fails). Headache. 2013 Jul-Aug;53(7):1183-90. doi: 10.1111/head.12148. Epub 2013 Jun 28.
PubMed 23808603McGeeney BE. Cannabinoids and hallucinogens for headache. Headache. 2013 Mar;53(3):447-58. doi: 10.1111/head.12025. Epub 2012 Dec 20.
PubMed 23278122Andersson M, Persson M, Kjellgren A. Psychoactive substances as a last resort-a qualitative study of self-treatment of migraine and cluster headaches. Harm Reduct J. 2017 Sep 5;14(1):60. doi: 10.1186/s12954-017-0186-6.
PubMed 28870224Sewell RA, Halpern JH, Pope HG Jr. Response of cluster headache to psilocybin and LSD. Neurology. 2006 Jun 27;66(12):1920-2. doi: 10.1212/01.wnl.0000219761.05466.43.
PubMed 16801660Schindler EA, Gottschalk CH, Weil MJ, Shapiro RE, Wright DA, Sewell RA. Indoleamine Hallucinogens in Cluster Headache: Results of the Clusterbusters Medication Use Survey. J Psychoactive Drugs. 2015 Nov-Dec;47(5):372-81. doi: 10.1080/02791072.2015.1107664. Epub 2015 Nov 23.
PubMed 26595349de Coo IF, Naber WC, Wilbrink LA, Haan J, Ferrari MD, Fronczek R. Increased use of illicit drugs in a Dutch cluster headache population. Cephalalgia. 2019 Apr;39(5):626-634. doi: 10.1177/0333102418804160. Epub 2018 Oct 5.
PubMed 30290701
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Minidosing Lysergic Acid Diethylamide (LSD) for Chronic Cluster Headache: a Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05477459
- Acronym / sponsor ID
- LICIT / 131-2022
- Conditions
- Chronic Cluster Headache
- Keywords
- Chronic cluster headache, Lysergic acid diethylamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Canisius-Wilhelmina Hospital, Leiden University Medical Center
- Study start
- 16 Apr 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment of cluster headache consists of acute remedies for attacks (mainly 100% O2, sumatriptan), transitional treatment for temporary frequency reduction (subcutaneous steroid injection at the greater occipital nerve (GON block), oral steroids or frovatriptan) and prolonged prophylaxis (e.g. verapamil, lithium, topiramate). Although the latter compounds have shown some efficacy in reducing the attack frequency, the evidence for their effect is weak. All current prophylactics are prescribed off-label and are limited in their utility due to associated side effects. Despite treatment, many (notably chronic) cluster headache patients continue suffering headache attacks.
Invasive, expensive treatments like hypothalamic deep brain stimulation, occipital nerve stimulation and sphenopalatine ganglion stimulation are last resort options. Recently, a monoclonal antibody targeting calcitonin gene related peptide (CGRP) received FDA approval for episodic cluster headache, but was shown to be ineffective in cCH. Thus, there is a considerable unmet need for effective treatments that are better tolerated, safe and affordable.
In this study, the investigators will assess the efficacy of prophylactic treatment with LSD in cCH. The evidence for the efficacy of LSD is limited, with the majority of data originating from case reports or uncontrolled and retrospective (internet) surveys. Nevertheless, these studies do provide indications that LSD may hold potential as a cluster headache prophylaxis.
The primary objective of this randomized double-blind placebo-controlled trial is to compare the efficacy of LSD 25μg every 3 days for 3 weeks versus placebo in cCH. The investigators aim to show that, at the end of treatment, verum is more efficacious than placebo with comparable tolerability in an ambulatory setting. To explore the sustainability of benefit the investigators will also assess the (sustained) response at 5 weeks post-treatment (8 weeks postrandomization).
If the study findings are positive, LSD should be further studied before use in routine clinical practice. Non-hallucinogenic low-dosed LSD may provide an alternative or adjunctive option for patients who do not respond to or cannot tolerate currently available treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 3-week double-blind placebo-controlled intervention study, preceded by a 4-week baseline observation period and followed by 5 weeks post-treatment observation period.
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: LSD tartrateLysergic diethylamide tartrate (equivalent to 25 microgram LSD base), one dose every 3 days for 3 weeks (totalling 7 vials) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo vial looking like verum vial, one vial every 3 days for 3 weeks (totalling 7 vials) |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSD tartrateAlso: Lysergic acid diethylamideLSD tartrate equivalent to 25 microgram LSD base | Drug | Verum |
| PlaceboPlacebo with equal appearance | Drug | Placebo |
Primary outcome
Mean change in weekly attack frequency, across treatments groups.
Time frame: week 3 of treatment
In week 3 post-randomization, compared to the 4-week baseline average per week
22 secondary outcomes
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
100% reduction (remission rate) in number of weekly attacks in the third treatment week, compared to the 4-week baseline, across treatment groups.
Time frame: week 3 post-randomization
≥50% reduction (50% responder rate) in number of weekly attacks in the third treatment week, compared to the 4-week baseline, across treatment groups.
Time frame: week 3 post-randomization
≥30% reduction (30% responder rate) in number of weekly attacks in the third treatment week, compared to the 4-week baseline, across treatment groups.
Time frame: week 3 post-randomization
100% reduction (remission rate) in number of weekly attacks across weeks 4-8 compared to the 4-week baseline and for each week separately.
Time frame: week 8 post-randomization
≥50% reduction (50% responder rate) in number of weekly attacks across weeks 4-8 compared to the 4-week baseline and for each week separately.
Time frame: week 8 post-randomization
≥30% reduction (30% responder rate) in number of weekly attacks across weeks 4-8 compared to the 4-week baseline and for each week separately.
Time frame: week 8 post-randomization
Mean change in weekly attack frequency in the entire 3 week treatment period compared to the 4-week baseline.
Time frame: week 3 post-randomization
Mean change in mean headache attack duration (minutes) per week, across treatment groups
Time frame: week 3 post-randomization
Mean change in mean headache attack duration (minutes) per week, across treatment groups
Time frame: week 8 post-randomization
Mean change in mean headache attack severity (VAS 1-10), across treatment groups
Time frame: week 3 post-randomization
Mean change in mean headache attack severity (VAS 1-10), across treatment groups
Time frame: week 8 post-randomization
Mean change in number of abortive medication use, across treatment groups
Time frame: week 3 post-randomization
Mean change in number of abortive medication use, across treatment groups
Time frame: week 8 post-randomization
Failure of sustained response'
Time frame: Weeks 4-8 post-randomization
Patient Global Impression of Change (PGIC)
Time frame: Day 21 post-randomization
Patient Global Impression of Change (PGIC)
Time frame: weeks 3 and 8
Health-related quality of life
Time frame: weeks 3 and 8
Hospital Anxiety and Depression Score (HADS)
Time frame: weeks 3 and 8.
Pharmacokinetic (PK)-pharmacodynamic (PD) modelling
Time frame: Day 18 post-randomization
Cost-effectiveness analysis (CEA) from a societal perspective comparing the LSD intervention with usual care.
Time frame: Week 1, 3 and 8
Efficacy of treatment masking
Time frame: Week 1 and 3 post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 29174963Hoffmann J, May A. Diagnosis, pathophysiology, and management of cluster headache. Lancet Neurol. 2018 Jan;17(1):75-83. doi: 10.1016/S1474-4422(17)30405-2. Epub 2017 Nov 23.
- Background: PubMed 22077141Rozen TD, Fishman RS. Cluster headache in the United States of America: demographics, clinical characteristics, triggers, suicidality, and personal burden. Headache. 2012 Jan;52(1):99-113. doi: 10.1111/j.1526-4610.2011.02028.x. Epub 2011 Nov 11.
- Background: PubMed 23808603Tepper SJ, Stillman MJ. Cluster headache: potential options for medically refractory patients (when all else fails). Headache. 2013 Jul-Aug;53(7):1183-90. doi: 10.1111/head.12148. Epub 2013 Jun 28.
- Background: PubMed 23278122McGeeney BE. Cannabinoids and hallucinogens for headache. Headache. 2013 Mar;53(3):447-58. doi: 10.1111/head.12025. Epub 2012 Dec 20.
- Background: PubMed 28870224Andersson M, Persson M, Kjellgren A. Psychoactive substances as a last resort-a qualitative study of self-treatment of migraine and cluster headaches. Harm Reduct J. 2017 Sep 5;14(1):60. doi: 10.1186/s12954-017-0186-6.
- Background: PubMed 16801660Sewell RA, Halpern JH, Pope HG Jr. Response of cluster headache to psilocybin and LSD. Neurology. 2006 Jun 27;66(12):1920-2. doi: 10.1212/01.wnl.0000219761.05466.43.
- Background: PubMed 26595349Schindler EA, Gottschalk CH, Weil MJ, Shapiro RE, Wright DA, Sewell RA. Indoleamine Hallucinogens in Cluster Headache: Results of the Clusterbusters Medication Use Survey. J Psychoactive Drugs. 2015 Nov-Dec;47(5):372-81. doi: 10.1080/02791072.2015.1107664. Epub 2015 Nov 23.
- Background: PubMed 30290701de Coo IF, Naber WC, Wilbrink LA, Haan J, Ferrari MD, Fronczek R. Increased use of illicit drugs in a Dutch cluster headache population. Cephalalgia. 2019 Apr;39(5):626-634. doi: 10.1177/0333102418804160. Epub 2018 Oct 5.
- Individual participant dataSharing planned: Yes. Individual patient data underlying publication, after deidentification, will be shared upon request to the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kees Kramers, Prof. principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LSD tartrate in people with Chronic Cluster Headache, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Jansen, MD (+31 24 3658765, julia.jansen@cwz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in weekly attack frequency, across treatments groups. (time frame: week 3 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477459, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.