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

NCT ID
NCT07755410
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Alkermes, Inc.
Conditions
Attention Deficit Disorder With Hyperactivity (ADHD)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Phase 2, Randomized, Parallel-Group, Double-Blind, Study to Evaluate the Safety and Efficacy of ALKS 7290 Compared to Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder

Enrollment: 312 participants (Estimated).

What is being studied

  • Drug: ALKS 7290
  • Drug: Placebo

Who may be eligible

Ages
18 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

2 study locations are listed.

Recruiting site status is explicitly provided for 2 locations; 2 are listed as Recruiting.

Countries: United States

  • California, United States: 1
  • Florida, United States: 1

Sample of listed locations

  • Alkermes Investigator Site — Chino, California, 91710, United States — Recruiting
  • Alkermes Investigator Site — Maitland, Florida, 32751, United States — Recruiting

Study details

Start date
August 1, 2026
Primary completion date
July 1, 2027
Completion date
July 1, 2027
First posted
August 10, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07755410
Registry last updated
August 10, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07755410 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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