Safety and Efficacy of Low Dose MM-120 for ADHD... — Clinical Trial Details

Multi-centre, randomised, double-blind, placebo-controlled Phase 2a study comparing low dose MM-120 (20 µg) with placebo, administered orally twice weekly for 6 weeks (12 doses) in adults with DSM-5 ADHD.

Primary purpose treatment; outcomes include safety and efficacy measures at Week 6. Actual enrolled count recorded as 53 participants.

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.

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Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial

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Placebo

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MM-120

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