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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Definium Therapeutics US, Inc.
Study ID
NCT06741228
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 - Voyage

Key Dates

Start date
Dec 11, 2024
Status verified
May 2025
Primary completion
May 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
214 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 - 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 (34)

FacilityCityStateZIPSite coordinators
Lighthouse PsychiatryGilbertArizona85234-
Scottsdale Research InstituteScottsdaleArizona85022-
Kadima Neuropsychiatry InstituteLa JollaCalifornia92037-
UCSF Department of NeurologySan FranciscoCalifornia94158-
Psychedelic Science InstituteSanta MonicaCalifornia90404-
Mountain ViewDenverColorado80209-
Clinical Neuroscience Solutions Inc.JacksonvilleFlorida32256-
Segal TrialsLauderhillFlorida33319-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
iResearch AtlantaDecaturGeorgia30030-
CenExel iResearch, LLCSavannahGeorgia31405-
Uptown Research InstituteChicagoIllinois60640-
Adams Clinical BostonBostonMassachusetts02116-
Adams Clinical WatertownWatertownMassachusetts02472-
Hassman Research InstituteMarltonNew Jersey08053-
Adams Clinical HarlemNew YorkNew York10029-
New York State Psychiatric Institute (NYSPI)New YorkNew York10032-
Spectrum Neuroscience and Treatment InstituteNew YorkNew York10021-
Adams Clinical BronxThe BronxNew York10461-
Cleveland Clinic Lutheran HospitalClevelandOhio44113-
Summit Headlands LLCPortlandOregon97210-
Scranton Medical InstituteMoosicPennsylvania18507-
Adams Clinical PhiladelphiaPhiladelphiaPennsylvania19104-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-
Clinical Neuroscience Solutions, Inc.MemphisTennessee38119-
Austin Clinical Trial PartnersAustinTexas78737-
BioBehavioral Research of AustinAustinTexas78759-
University of Texas at AustinAustinTexas78712-
FutureSearch Trials of Dallas, LLCDallasTexas75231-
Adams Clinical DallasDeSotoTexas75115-
Cedar Clinical ResearchDraperUtah84020-
Inner Space ResearchOremUtah84058-
Memory Clinic Inc.BenningtonVermont05201-
Seattle Neuropsychiatric Treatment CenterSeattleWashington98104-

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