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NCT07755410PHASE2Recruiting

A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)

Alkermes, Inc.

Start Date

8/10/2026

Completion Date

7/1/2027

Summary

The purpose of this study is to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with placebo tablets.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Meets the Diagnostic and Statistical Manual of Mental Disorders -5 criteria for ADHD, as confirmed by the Mini-International Neuropsychiatric Interview (MINI) for ADHD Studies 7.0.2. * Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants must be stable on permitted medication for 2 months prior to first visit, without anticipated changes to dose. * AISRS total score of ≥26 * CGI-S score ≥ 4 (moderately ill or worse) * Has a Body Mass Index within 18 to 35 kg/m2 Exclusion Criteria: * Has a known history of intellectual developmental disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with study participation. * Has any of the following psychiatric conditions per the DSM-5 criteria, as assessed by the MINI. Conditions not assessable by the MINI should be assessed by clinical judgement; Diagnosis of schizophrenia, schizoaffective disorder, or bipolar I or II disorder, or current, unstable, MDD or GAD. * Clinically significant cognitive difficulties including dementia, delirium or amnestic syndromes, or any other cognitive disorder present with the past 2 years that could interfere with participation in the study. * Moderate to severe substance use disorder according to DSM-5 guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit substance. * Any other psychiatric condition that could interfere with participation in the study.

Interventions

DRUG

ALKS 7290

DRUG

Placebo

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Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Locations

Alkermes Investigational Site

Little Rock, Arkansas 72211

United States

Alkermes Investigational Site

Chino, California 91710

United States

Alkermes Investigator Site

Chino, California 91710

United States

Alkermes Investigational Site

Clermont, Florida 34711

United States

Alkermes Investigational Site

Jacksonville, Florida 32256

United States

Alkermes Investigational Site

Lakeland, Florida 33803

United States

Alkermes Investigational Site

Largo, Florida 33777

United States

Alkermes Investigational Site

Maitland, Florida 32751

United States

Alkermes Investigator Site

Maitland, Florida 32751

United States

Alkermes Investigational Site

Maitland, Florida 98007

United States

Alkermes Investigational Site

Orlando, Florida 32801

United States

Alkermes Investigational Site

Tampa, Florida 33634

United States

Alkermes Investigational Site

Decatur, Georgia 30030

United States

Alkermes Investigational Site

Memphis, Michigan 38119

United States

Alkermes Investigational Site

North Canton, Ohio 44720

United States

Alkermes Investigational Site

East Providence, Rhode Island 02914

United States

Alkermes Investigational Site

North Charleston, South Carolina 29405

United States

Alkermes Investigational Site

Austin, Texas 78759

United States

Alkermes Investigational Site

Bellevue, Washington 98007

United States