A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
A Phase 2, Multi-center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Study to Assess the Effect of Four Doses of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms
Sponsor: Definium Therapeutics US, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose Response
Time frame: 4 weeks
Secondary Endpoints
Dose Response
Change From Baseline in HAM-A Total Score
Change From Baseline in HAM-A Total Scores
Eligibility Criteria
Inclusion Criteria: * Bodyweight of ≥ 50 kg * Body mass index \[BMI\] ≥ 18 to ≤ 38 mg/kg2 * Diagnosis of DSM-5 generalized anxiety disorder * Acceptable overall medical condition to be safely enrolled into and to complete the study * Ability to swallow capsules * Ability to provide informed consent Exclusion Criteria: * Women of childbearing potential (WOCBP) (i.e., physiologically capable of becoming pregnant) who are unwilling or unable to use a highly effective method of contraception for the duration of the study, OR Men physiologically capable of fathering a child who are sexually active with WOCBP but are unwilling or unable to use barrier contraception (e.g., condom with or without spermicidal cream or jelly) for the duration of the study * Women who are currently pregnant or breastfeeding or plan to become pregnant or breastfeed during the study * Men who plan to donate sperm during the study * Prior history (lifetime diagnosis) with a lifetime diagnosis of schizophrenia spe…
Read full criteria on CT.gov →✦ Analyst Commentary
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