Recruiting
Phase 2

ALKS 7290

Sponsor:

Alkermes, Inc.

Code:

NCT07755410

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ALKS 7290

Placebo

Study Details

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Study ID

NCT07755410

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

312 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Level 1

experimental: Dose Level 2

experimental: Dose Level 3

placebo comparator: Placebo

Placebo capsule taken daily

Interventions

ALKS 7290

ALKS 7290 tablets taken daily, orally, for 4 weeks

Placebo

Placebo capsule taken daily

Primary outcome measure

  • Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score [ Time Frame: Baseline to Week 4 ]

Central Contacts and Locations

Central contacts

Global Clinical Services

888-235-8008 (US Only)clinicaltrials@alkermes.com

Global Clinical Services

571-599-2702 (Global)clinicaltrials@alkermes.com

Locations

Alkermes Investigator Site

Recruiting

Chino, California, United States, 91710

Alkermes Investigator Site

Recruiting

Maitland, Florida, United States, 32751

More Information

Sponsor

Alkermes, Inc.

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • ADHD
  • Attention Deficit Disorder with Hyperactivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alkermes, Inc. on 2026-08-10.