CompletedPhase 2LSD
Safety and Efficacy of Low Dose MM120 for ADHD Proof of Concept Trial
Sponsored by Definium Therapeutics US, Inc.
NCT ID
NCT05200936
Target Enrollment
53 participants
Start Date
2021-12-17
Est. Completion
2023-12-04
About This Study
This study measures the safety and efficacy of repeated low dose MM120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled
Conditions Studied
Interventions
- •MM120
- •Placebo
Eligibility
Age:18 Years - 65 Years
Healthy Volunteers:No
View full 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 prescription or non-prescription ADHD medications. * Use of investigational medication/treatment in the past 30 days. * Patients with a positive urine drug screen with the exception of THC or its metabolites. * Pregnant or nursing females.
Study Locations (2)
Maastricht University
Maastricht, Netherlands
University Hospital Basel
Basel, Switzerland