CompletedPhase 2Other
Safety and Efficacy of Low Dose MM-120 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 MM-120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled
Conditions Studied
Interventions
- •MM-120
- •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