Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial
Safety and Efficacy of Repeated Low Dose d-Lysergic Acid Diethylamide (LSD) D-tartrate (MM120) as Treatment for ADHD in Adults: a Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2a Proof of Concept Trial
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)
Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms
Time frame: 6 weeks
Secondary Endpoints
Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms
Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S)
Change From Baseline in in Clinical Global Impressions Scale (CGI-S)
Eligibility Criteria
Inclusion Criteria: * Male and female outpatients ≥ 18 and ≤ 65 years of age at Screening * Patients with the diagnosis of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured interview (MINI). * Adequate organ function. * Able to understand the study procedures and understand risks associated with the study, and sign written informed consent to participate in the study. * Must be willing to refrain from more than 6 standard alcoholic drinks a week, more than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the study treatment period (6 weeks) and until the last study visit is complete. Exclusion Criteria: * Past or present diagnosis of a primary psychotic disorder or first degree relative with a psychotic disorder. * Past or present bipolar disorder (DSM-5). * Any lifetime history of suicide attempt. * Once Informed Consent form is signed, not willing or able to stop any prescripti…
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