Clinical TrialPlaceboCompleted

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

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 trial.

Target Enrollment
53 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

12 sessions

Integration

sessions

Study Arms & Interventions

Placebo

inactive

Placebo identical in appearance to the investigational product administered orally twice weekly for 6 weeks.

Interventions

  • Placebo
    via Oral• twice weekly• 12 doses total

    Placebo identical to IMP, administered twice weekly for 6 weeks.

MM-120

experimental

MM-120 20 µg administered orally twice weekly for 6 weeks (12 total doses).

Interventions

  • Compound20 µg
    via Oral• twice weekly• 12 doses total

    MM-120 20 µg, oral, twice weekly for 6 weeks (3/4-day schedule).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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 Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment53 participants
  • Timeline
    Start: 2021-12-17
    End: 2023-11-27
  • Compound
    Placebo

Locations

Maastricht University — Maastricht, Netherlands
University Hospital Basel — Basel, Switzerland

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