A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Definium Therapeutics US, Inc.
Study ID
NCT05407064
Phase
PHASE2
Status
Completed

Conditions

  • Anxiety Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • MM120 — DRUG
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
  • Placebo — OTHER
    A substance that is designed to have no therapeutic value.

Study Details

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Key Dates

Start date
Aug 24, 2022
Status verified
Sep 2025
Primary completion
Oct 6, 2023
Completion
Nov 27, 2023

Study Design

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

Arms

  • Placebo Comparator: Arm 1- Placebo
    A substance that is designed to have no therapeutic value.
  • Experimental: Arm 2- 25 μg MM120
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
  • Experimental: Arm 3- 50 μg MM120
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
  • Experimental: Arm 4- 100 μg MM120
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
  • Experimental: Arm 5- 200 μg MM120
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).

Primary Outcome Measure

Dose Response [ Time Frame: 4 weeks ]

Locations (22)

FacilityCityStateZIPSite coordinators
Preferred Research PartnersLittle RockArkansas72211-
Irvine Center for Clinical ResearchIrvineCalifornia92614-
Kadima Neuropsychiatry InstituteLa JollaCalifornia92037-
Pacific Neuroscience InstituteSanta MonicaCalifornia90404-
Mountain View Clinical ResearchDenverColorado80209-
Wholeness CenterFort CollinsColorado80525-
Segal TrialsLauderhillFlorida33319-
CNS Healthcare - OrlandoOrlandoFlorida32801-
iResearch AtlantaDecaturGeorgia30030-
Great Lakes Clinical TrialsChicagoIllinois60640-
Uptown ResearchChicagoIllinois60640-
Sunstone TherapiesRockvilleMaryland20850-
SISUSpringfieldMassachusetts01103-
Adams ClinicalWatertownMassachusetts02472-
Hassman Research InstituteBerlinNew Jersey08009-
GMI - Princeton Medical InstitutePrincetonNew Jersey08540-
Lutheran Hospital - Cleveland ClinicClevelandOhio44113-
BioBehavioral Research of AustinAustinTexas78759-
University of Texas Health HoustonHoustonTexas77054-
Cedar Clinical ResearchDraperUtah84020-
Cedar Clinical Research - MurrayMurrayUtah84107-
Woodstock Research CenterWoodstockVermont05091-

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