Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial

Sponsor
Definium Therapeutics US, Inc.
Study ID
NCT05200936
Phase
PHASE2
Status
Completed

Conditions

  • ADHD
  • Attention Deficit Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MM120 — DRUG
    MM120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM120 manifests primarily visual, as well as auditory, hallucinations.
  • Placebo — OTHER
    A treatment which is designed to have no therapeutic value.

Study Details

This study measures the safety and efficacy of repeated low dose MM120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled

Key Dates

Start date
Dec 17, 2021
Status verified
Mar 2025
Primary completion
Nov 6, 2023
Completion
Dec 4, 2023

Study Design

Enrollment
53 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1- Placebo
    A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks.
  • Experimental: Arm 2- MM120
    A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks.

Primary Outcome Measure

Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms [ Time Frame: 6 weeks ]

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