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LYSERGIDE

Clinical trials are investigating LYSERGIDE in different patient groups to see whether it can help with symptoms and whether it is safe and effective in study settings. The trials in this article include adults with generalized anxiety disorder, chronic cluster headache, and attention deficit hyperactivity disorder (ADHD).

Table of Contents

Trial overview

The trial data show three interventional studies investigating LYSERGIDE-related treatments in adults with different conditions.[1][2][3] Two studies are authorised, and one study was withdrawn.[1][2][3]

The studies are in Phase 2 and Phase 3, which means they are testing whether the study treatments may help symptoms and how they compare with placebo in larger or smaller groups.[1][2][3]

Generalized anxiety disorder study

NCT06809595 is a Phase 3, double-blind, placebo-controlled study with an open-label extension for adults with Generalized Anxiety Disorder (GAD).[1] The study is authorised and plans to enroll 375 participants.[1]

In Part A, the main goal is to compare a single dose of 100 μg MM120 with placebo to see whether anxiety symptoms improve.[1] The main outcome is the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12.[1]

This means the study is measuring whether anxiety scores go down over time in the group receiving the study treatment compared with the placebo group.[1]

Chronic cluster headache study

NCT05477459 is a Phase 2 randomized placebo-controlled study in adults with chronic cluster headache.[2] It is authorised and plans to enroll 52 participants.[2]

The study is evaluating the efficacy and safety of minidosing lysergic acid diethylamide (LSD) 25 μg every 3 days for 3 weeks, compared with placebo.[2] The primary outcome is the mean change in weekly attack frequency in the third treatment week compared with the 4-week baseline.[2]

This endpoint focuses on whether the number of headache attacks changes during treatment, which is a practical way to measure possible benefit for patients.[2]

ADHD and emotion regulation study

The third trial, 2025-520906-36-00, is a Phase 2 interventional study in adults with Attention Deficit Hyperactivity Disorder (ADHD).[3] It was planned to enroll 120 participants but is now withdrawn.[3]

The brief summary says the study aimed to investigate whether microdosing with a serotonergic agent, given as 20 mcg of LSD, may improve core ADHD symptoms, emotional regulation, and sleep.[3] The primary outcomes listed are ADHD symptoms, emotion regulation, and sleep.[3]

This trial was designed to look beyond attention symptoms alone and see whether daily life areas such as emotion control and sleep could also change.[3]

Study designs and endpoints

Across the trial data, the studies use common clinical research designs such as double-blind, placebo-controlled, and randomized methods.[1][2]

These designs help compare the study treatment with placebo in a fair way and reduce the chance that expectations affect the results.[1][2]

The main endpoints differ by condition: anxiety score change for GAD, weekly headache attack frequency for chronic cluster headache, and ADHD symptoms with emotion regulation and sleep for the ADHD study.[1][2][3]

Who can participate

The target populations in these trials are adults with the condition being studied.[1][2][3] That includes adults with generalized anxiety disorder, chronic cluster headache, or ADHD.[1][2][3]

Because each study has its own rules, the exact participation criteria are not fully listed in the trial data provided here.[1][2][3]

Key terms used in the trials

Open-label extension means that after the blinded part of the study, participants and researchers know what treatment is being used.[1]

Baseline means the starting point before treatment, which is used to compare later results.[1][2]

Primary outcome means the main result the study is designed to measure.[1][2][3]

Weekly attack frequency means the number of headache attacks in one week.[2]

Emotion regulation means how well a person can manage and respond to emotions in daily life.[3]

Trial ID Phase Condition studied Status Enrollment
NCT06809595 Phase 3 Generalized Anxiety Disorder (GAD) Authorised 375
NCT05477459 Phase 2 Chronic cluster headache Authorised 52
2025-520906-36-00 Phase 2 Attention Deficit Hyperactivity Disorder (ADHD) Withdrawn 120

FAQ

  • What is being studied in clinical trials of LYSERGIDE? The trials are testing LYSERGIDE-related study treatments in adults with generalized anxiety disorder, chronic cluster headache, and ADHD. They are looking at symptom improvement, safety, and other outcomes such as sleep and emotion regulation.
  • Who can take part in these studies? Each trial has its own rules, but the target groups are adults with the condition being studied. For example, one study is for adults with generalized anxiety disorder, another for chronic cluster headache, and another for adults with ADHD.
  • What phases are the LYSERGIDE trials in? The trials listed are in Phase 2 and Phase 3. Phase 2 studies usually look at early proof of benefit and safety, while Phase 3 studies compare treatment with placebo in larger groups.
  • What conditions are being studied? The conditions are generalized anxiety disorder, chronic cluster headache, and attention deficit hyperactivity disorder. These studies are designed to see whether the trial treatments may improve the main symptoms of each condition.
  • What kinds of results are the trials measuring? The studies measure outcomes such as anxiety scores, weekly headache attack frequency, ADHD symptoms, emotion regulation, and sleep. These are used to see whether the treatment changes symptoms over time.

Ongoing Clinical Trials on LYSERGIDE

  • Study on the Effects of Lysergide for Patients with Chronic Cluster Headache

    Recruiting

    2 1
    Investigated drugs:
    The Netherlands

  • Microdosing lysergide (20 µg) to improve symptoms, emotion regulation and sleep in adults with ADHD

    Not yet recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effects of MM120 (Lysergide) for Adults with Generalized Anxiety Disorder

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Poland

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, works well, and is better than a comparison treatment such as placebo.
  • Phase 2: An earlier trial stage that usually looks at whether a treatment may work and continues to check safety in a smaller group.
  • Phase 3: A later trial stage that usually compares a treatment with placebo or another treatment in a larger group of people.
  • Placebo: An inactive treatment that looks like the study treatment but does not contain the active study drug.
  • Double-blind: A study design where neither the participants nor the study team know who is receiving the study treatment, which helps reduce bias.
  • Open-label extension: A study period after the blinded part of a trial where both the participants and the researchers know what treatment is being given.
  • Randomized: Assigned by chance to different study groups, which helps make the groups fair to compare.
  • Primary outcome: The main result the trial is designed to measure, such as symptom score or attack frequency.
  • Hamilton Anxiety Rating Scale (HAM-A): A rating scale used to measure anxiety symptoms. A change in the score shows whether anxiety got better or worse during the study.
  • Baseline: The starting point before treatment begins, used for comparison with later results.

References