A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Definium Therapeutics US, Inc.
Study ID
NCT06809595
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

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

Interventions

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

Study Details

A Phase 3, Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Panorama

Key Dates

Start date
Jan 29, 2025
Status verified
May 2025
Primary completion
Nov 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
245 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
  • Sham Comparator: Arm 2 - 50µg MM120 (LSD D-Tartrate)
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
  • Experimental: Arm 3 - 100µg MM120 (LSD D-Tartrate)
    A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Primary Outcome Measure

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12 [ Time Frame: Baseline to Week 12 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Preferred Research Partners, Inc.Little RockArkansas72211-
Psychedelic Science InstituteLos AngelesCalifornia90004-
West Los Angeles VA Medical CenterLos AngelesCalifornia90073-
Bradenton Research Center, Inc.BradentonFlorida34205-
Clinical Neuroscience Solutions, IncOrlandoFlorida32801-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
Sheppard Pratt Health SystemTowsonMaryland21204-
Adams Clinical BostonBostonMassachusetts02116-
Princeton Medical InstitutePrincetonNew Jersey08540-
University of Cincinnati Psychiatry- Anxiety Disorders Research ProgramCincinnatiOhio45219-
Neuro-Behavioral Clinical Research, Inc.North CantonOhio44720-
Austin Clinical Trial PartnersAustinTexas78737-
Cedar Clinical ResearchMurrayUtah84107-
Core Clinical ResearchEverettWashington98201-

Find similar trials in Little Rock, AR

By research site
Preferred Research Partners, Inc.· Little Rock, ARPsychedelic Science Institute· Los Angeles, CAWest Los Angeles VA Medical Center· Los Angeles, CABradenton Research Center, Inc.· Bradenton, FLClinical Neuroscience Solutions, Inc· Orlando, FLAtlanta Center for Medical Research· Atlanta, GA

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