A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Alkermes, Inc. · NCT07755410
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 312
- US sites recruiting
- 19
- Study start
- August 10, 2026
- Record last updated
- October 7, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ALKS 7290; Placebo
Conditions: Attention Deficit Disorder With Hyperactivity (ADHD)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Alkermes Investigational Site
Little Rock, AR 72211
Alkermes Investigational Site
Chino, CA 91710
Alkermes Investigator Site
Chino, CA 91710
Alkermes Investigational Site
Clermont, FL 34711
Alkermes Investigational Site
Jacksonville, FL 32256
Alkermes Investigational Site
Lakeland, FL 33803
Alkermes Investigational Site
Largo, FL 33777
Alkermes Investigational Site
Maitland, FL 32751
Alkermes Investigator Site
Maitland, FL 32751
Alkermes Investigational Site
Maitland, FL 98007
Alkermes Investigational Site
Orlando, FL 32801
Alkermes Investigational Site
Tampa, FL 33634
Alkermes Investigational Site
Decatur, GA 30030
Alkermes Investigational Site
Memphis, MI 38119
Alkermes Investigational Site
North Canton, OH 44720
Alkermes Investigational Site
East Providence, RI 02914
Alkermes Investigational Site
North Charleston, SC 29405
Alkermes Investigational Site
Austin, TX 78759
Alkermes Investigational Site
Bellevue, WA 98007
Study contacts (from the official record)
- Global Clinical Services · 888-235-8008 (US Only) · clinicaltrials@alkermes.com
- Global Clinical Services · 571-599-2702 (Global) · clinicaltrials@alkermes.com
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