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Recruiting Phase 2

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

NCT07755410 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-08-10
Last updated
2026-10-29

Condition(s) studied

Attention Deficit Disorder With Hyperactivity (ADHD)

Investigational drug(s) / intervention(s)

ALKS 7290 →Placebo

ALKS 7290: ALKS 7290 tablets taken daily, orally, for 4 weeks

Placebo: Placebo capsule taken daily

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score — Baseline to Week 4

Trial sites (28)

FacilityCityRegionStatus
Alkermes Investigational Site Little Rock Arkansas Recruiting
Alkermes Investigational Site Chino California Recruiting
Alkermes Investigator Site Chino California Recruiting
Alkermes Investigational Site Clermont Florida Recruiting
Alkermes Investigational Site Jacksonville Florida Recruiting
Alkermes Investigational Site Lakeland Florida Recruiting
Alkermes Investigational Site Largo Florida Recruiting
Alkermes Investigational Site Maitland Florida Recruiting
Alkermes Investigator Site Maitland Florida Recruiting
Alkermes Investigational Site Maitland Florida Recruiting
Alkermes Investigational Site Orange City Florida Recruiting
Alkermes Investigational Site Orlando Florida Recruiting
Alkermes Investigational Site Tampa Florida Recruiting
Alkermes Investigational Site Decatur Georgia Recruiting
Alkermes Investigational Site Foxborough Massachusetts Recruiting
Alkermes Investigational Site Watertown Massachusetts Recruiting
Alkermes Investigational Site Detroit Michigan Recruiting
Alkermes Investigational Site Memphis Michigan Recruiting
Alkermes Investigational Site Lincoln Nebraska Recruiting
Alkermes Investigational Site Las Vegas Nevada Recruiting
Alkermes Investigational Site Las Vegas Nevada Recruiting
Alkermes Investigational Site North Canton Ohio Recruiting
Alkermes Investigational Site East Providence Rhode Island Recruiting
Alkermes Investigational Site North Charleston South Carolina Recruiting
Alkermes Investigational Site Austin Texas Recruiting
Alkermes Investigational Site Austin Texas Recruiting
Alkermes Investigational Site The Woodlands Texas Recruiting
Alkermes Investigational Site Bellevue Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07755410 on ClinicalTrials.gov ↗ ← All trials in the USA