ClinicalTrials.gg
RecruitingNCT07755410Updated Oct 29, 2026

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

A Phase 2 interventional study of ALKS 7290 and Placebo in Attention Deficit Disorder With Hyperactivity (ADHD), sponsored by Alkermes, Inc.. Recruiting at 28 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Alkermes, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Oct 29, 202626 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
312
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Attention Deficit Disorder With Hyperactivity (ADHD)

Keywords

  • ADHD
  • Attention Deficit Disorder with Hyperactivity
03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 312 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Alkermes, Inc. is the lead sponsor of 83 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meets the -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 within 18 to 35 kg/m2

Exclusion criteria

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 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.
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
312 participants (estimated)

Study arms

  • Experimental
    Dose Level 1

    Drug: ALKS 7290

  • Experimental
    Dose Level 2

    Drug: ALKS 7290

  • Experimental
    Dose Level 3

    Drug: ALKS 7290

  • Placebo comparator
    Placebo

    Placebo capsule taken daily

    Drug: Placebo

Interventions

  • DrugALKS 7290

    ALKS 7290 tablets taken daily, orally, for 4 weeks

  • DrugPlacebo

    Placebo capsule taken daily

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline to Week 4

Secondary outcomes

  1. Change from Baseline to Week 4 in Clinical Global Impression- Severity (CGI-S) scale score

    Time frame: Baseline to Week 4

  2. Incidence of treatment-emergent adverse events

    Time frame: Up to 6 weeks

07

Study locations

28 of 28 sites recruiting
  • Alkermes Investigational Site
    Little Rock, Arkansas 72211, United States
    Recruiting
  • Alkermes Investigational Site
    Chino, California 91710, United States
    Recruiting
  • Alkermes Investigator Site
    Chino, California 91710, United States
    Recruiting
  • Alkermes Investigational Site
    Clermont, Florida 34711, United States
    Recruiting
  • Alkermes Investigational Site
    Jacksonville, Florida 32256, United States
    Recruiting
  • Alkermes Investigational Site
    Lakeland, Florida 33803, United States
    Recruiting
  • Alkermes Investigational Site
    Largo, Florida 33777, United States
    Recruiting
  • Alkermes Investigational Site
    Maitland, Florida 32751, United States
    Recruiting
  • Alkermes Investigator Site
    Maitland, Florida 32751, United States
    Recruiting
  • Alkermes Investigational Site
    Maitland, Florida 98007, United States
    Recruiting
  • Alkermes Investigational Site
    Orange City, Florida 32763, United States
    Recruiting
  • Alkermes Investigational Site
    Orlando, Florida 32801, United States
    Recruiting
  • Alkermes Investigational Site
    Tampa, Florida 33634, United States
    Recruiting
  • Alkermes Investigational Site
    Decatur, Georgia 30030, United States
    Recruiting
  • Alkermes Investigational Site
    Foxborough, Massachusetts 02035, United States
    Recruiting
  • Alkermes Investigational Site
    Watertown, Massachusetts 02472, United States
    Recruiting
  • Alkermes Investigational Site
    Detroit, Michigan 48203, United States
    Recruiting
  • Alkermes Investigational Site
    Memphis, Michigan 38119, United States
    Recruiting
  • Alkermes Investigational Site
    Lincoln, Nebraska 68526, United States
    Recruiting
  • Alkermes Investigational Site
    Las Vegas, Nevada 89119, United States
    Recruiting
  • Alkermes Investigational Site
    Las Vegas, Nevada 89128, United States
    Recruiting
  • Alkermes Investigational Site
    North Canton, Ohio 44720, United States
    Recruiting
  • Alkermes Investigational Site
    East Providence, Rhode Island 02914, United States
    Recruiting
  • Alkermes Investigational Site
    North Charleston, South Carolina 29405, United States
    Recruiting
  • Alkermes Investigational Site
    Austin, Texas 78737, United States
    Recruiting
  • Alkermes Investigational Site
    Austin, Texas 78759, United States
    Recruiting
  • Alkermes Investigational Site
    The Woodlands, Texas 77381, United States
    Recruiting
  • Alkermes Investigational Site
    Bellevue, Washington 98007, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Sites
26 sites added
Show 26 added (26 United States)
  • Alkermes Investigational Site · Little Rock, United States
  • Alkermes Investigational Site · Chino, United States
  • Alkermes Investigational Site · Clermont, United States
  • Alkermes Investigational Site · Jacksonville, United States
  • Alkermes Investigational Site · Lakeland, United States
  • Alkermes Investigational Site · Largo, United States
  • Alkermes Investigational Site · Maitland, United States
  • Alkermes Investigational Site · Maitland, United States
  • Alkermes Investigational Site · Orlando, United States
  • Alkermes Investigational Site · Tampa, United States
  • Alkermes Investigational Site · Decatur, United States
  • Alkermes Investigational Site · Memphis, United States
  • Alkermes Investigational Site · North Canton, United States
  • Alkermes Investigational Site · East Providence, United States
  • Alkermes Investigational Site · North Charleston, United States
  • Alkermes Investigational Site · Austin, United States
  • Alkermes Investigational Site · Bellevue, United States
  • Alkermes Investigational Site · Orange City, United States
  • Alkermes Investigational Site · Foxborough, United States
  • Alkermes Investigational Site · Watertown, United States
  • Alkermes Investigational Site · Detroit, United States
  • Alkermes Investigational Site · Lincoln, United States
  • Alkermes Investigational Site · Las Vegas, United States
  • Alkermes Investigational Site · Las Vegas, United States
  • Alkermes Investigational Site · Austin, United States
  • Alkermes Investigational Site · The Woodlands, United States
across 2 updates, Oct 7, 2026 – Oct 29, 2026
Show all 2 updates
  1. Oct 29, 2026
    9 sites added
    Show 9 added (9 United States)
    • Alkermes Investigational Site · Orange City, United States
    • Alkermes Investigational Site · Foxborough, United States
    • Alkermes Investigational Site · Watertown, United States
    • Alkermes Investigational Site · Detroit, United States
    • Alkermes Investigational Site · Lincoln, United States
    • Alkermes Investigational Site · Las Vegas, United States
    • Alkermes Investigational Site · Las Vegas, United States
    • Alkermes Investigational Site · Austin, United States
    • Alkermes Investigational Site · The Woodlands, United States
  2. Oct 7, 2026
    17 sites added
    Show 17 added (17 United States)
    • Alkermes Investigational Site · Little Rock, United States
    • Alkermes Investigational Site · Chino, United States
    • Alkermes Investigational Site · Clermont, United States
    • Alkermes Investigational Site · Jacksonville, United States
    • Alkermes Investigational Site · Lakeland, United States
    • Alkermes Investigational Site · Largo, United States
    • Alkermes Investigational Site · Maitland, United States
    • Alkermes Investigational Site · Maitland, United States
    • Alkermes Investigational Site · Orlando, United States
    • Alkermes Investigational Site · Tampa, United States
    • Alkermes Investigational Site · Decatur, United States
    • Alkermes Investigational Site · Memphis, United States
    • Alkermes Investigational Site · North Canton, United States
    • Alkermes Investigational Site · East Providence, United States
    • Alkermes Investigational Site · North Charleston, United States
    • Alkermes Investigational Site · Austin, United States
    • Alkermes Investigational Site · Bellevue, United States
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07755410
Lead sponsor
Alkermes, Inc.
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Aug 10, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Global Clinical Services
Contact
clinicaltrials@alkermes.com
888-235-8008 (US Only)
Global Clinical Services
Contact
clinicaltrials@alkermes.com
571-599-2702 (Global)
Medical Director, MD
study director · Alkermes, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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