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LSD to Improve Cluster Headache Impact Trial

NCT05477459 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-04-15

No results posted yet for this study

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 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.

Conditions

  • Chronic Cluster Headache

Interventions

DRUG

LSD tartrate

LSD tartrate equivalent to 25 microgram LSD base

DRUG

Placebo

Placebo with equal appearance

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Canisius-Wilhelmina Hospital

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Kees Kramers, Prof. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477459 on ClinicalTrials.gov