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 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ALKS 7290-201
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 2

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)

Keywords

ADHD; Attention Deficit Disorder with Hyperactivity

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 4

Secondary Outcomes (2)

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

  Baseline to Week 4

• Incidence of treatment-emergent adverse events

  Up to 6 weeks

Study Arms (4)

Dose Level 1

EXPERIMENTAL

Drug: ALKS 7290

Dose Level 2

EXPERIMENTAL

Drug: ALKS 7290

Dose Level 3

EXPERIMENTAL

Drug: ALKS 7290

Placebo

PLACEBO COMPARATOR

Placebo capsule taken daily

Drug: Placebo

Interventions

ALKS 7290 DRUG

ALKS 7290 tablets taken daily, orally, for 4 weeks

Dose Level 1; Dose Level 2; Dose Level 3

Placebo DRUG

Placebo capsule taken daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (2)

Alkermes Investigator Site

Chino, California, 91710, United States

RECRUITING

Alkermes Investigator Site

Maitland, Florida, 32751, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Medical Director, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Central Study Contacts

Global Clinical Services

CONTACT

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

Global Clinical Services

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)