ALKS 7290 vs placebo in adults with ADHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study compares ALKS 7290 tablets to placebo in adults diagnosed with ADHD. Participants must meet DSM-5 criteria for ADHD and be medically stable, with specific symptom and BMI requirements. The study will assess safety and whether symptoms improve on ALKS 7290 compared with placebo, using standard assessments and monitoring. Enrollment is at Alkermes investigational sites in Little Rock, AR and Chino, CA.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alkermes Investigational Site
  Little Rock, Arkansas, United States Recruiting
• Alkermes Investigational Site
  Chino, California, United States Recruiting
• Alkermes Investigator Site
  Chino, California, United States Recruiting
• Alkermes Investigational Site
  Clermont, Florida, United States Recruiting
• Alkermes Investigational Site
  Jacksonville, Florida, United States Recruiting
• Alkermes Investigational Site
  Lakeland, Florida, United States Recruiting

Study contacts

• Study coordinator: Global Clinical Services
• Email: clinicaltrials@alkermes.com
• Phone: 888-235-8008 (US Only)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Unified care and integrated treatments for ADHD with substance use in prison settings

  Aimed at people under correctional supervision who have ADHD and substance use disorder, this program tests a coordinated care approach to improve identification and support.

  Recruiting University Hospital, Brest · Brest · NCT07487155

• Behavioral parent training with optional AI support for children with disruptive behaviors

  This trial will test whether adding a 24/7 AI assistant to online group behavioral parent training helps parents manage children aged 5–12 with disruptive behaviors.

  Recruiting Fundació Sant Joan de Déu · Barcelona, Barcelona · NCT07469215

• How the mediodorsal thalamus supports flexible thinking and decision making

  This study will test whether the mediodorsal thalamus helps flexible thinking in healthy adults, with implications for people with schizophrenia or ADHD.

  Recruiting University of Iowa · Iowa City, Iowa · NCT07217652

• Nightly external trigeminal nerve stimulation to reduce ADHD symptoms in children with autism

  This trial will test whether a small, nightly forehead patch that delivers external trigeminal nerve stimulation can reduce ADHD symptoms in children with autism.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07214545

• Pai.ACT: AI-powered chatbot-assisted ACT for parents of children with neurodevelopmental disorders

  This trial tests a chatbot-guided ACT program for Cantonese-speaking parents of young children with neurodevelopmental disorders to see if it helps reduce parenting stress and improves family well-being.

  Recruiting Chinese University of Hong Kong · Hong Kong · NCT06779422

• Health promotion for ultra-Orthodox mothers of children with ADHD

  This study tests a new support program for ultra-Orthodox mothers of children with ADHD to see if it can help them feel less stressed and improve their overall well-being.

  Recruiting Hebrew University of Jerusalem · Jerusalem · NCT06703242

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.