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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Attention Deficit Disorder With Hyperactivity (ADHD)

In brief

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.

Key facts

Study ID

NCT07755410

Run by

Alkermes, Inc.

People needed

312

Starts

2026-08-01

Expected to finish

2027-07-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Alkermes Investigator Site — Chino, California, United States (enrolling)
• Alkermes Investigator Site — Maitland, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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