Attention Deficit Disorder With Hyperactivity (ADHD)Phase 2NCT07755410
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 study testing ALKS 7290 in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by Alkermes, Inc. at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- ALKS 7290
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 19 sitesUnited States
- Study dates
- 10 Aug 2026to Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
Alkermes Investigational Site
Austin, Texas, 78759
- Recruiting
Alkermes Investigational Site
Bellevue, Washington, 98007
- Recruiting
Alkermes Investigational Site
Chino, California, 91710
- Recruiting
Alkermes Investigator Site
Chino, California, 91710
- Recruiting
Alkermes Investigational Site
Clermont, Florida, 34711
- Recruiting
Alkermes Investigational Site
Decatur, Georgia, 30030
- Recruiting
Alkermes Investigational Site
East Providence, Rhode Island, 02914
- Recruiting
Alkermes Investigational Site
Jacksonville, Florida, 32256
- Recruiting
Alkermes Investigational Site
Lakeland, Florida, 33803
- Recruiting
Alkermes Investigational Site
Largo, Florida, 33777
- Recruiting
Alkermes Investigational Site
Little Rock, Arkansas, 72211
- Recruiting
Alkermes Investigational Site
Maitland, Florida, 32751
- Recruiting
Alkermes Investigator Site
Maitland, Florida, 32751
- Recruiting
Alkermes Investigational Site
Maitland, Florida, 98007
- Recruiting
Alkermes Investigational Site
Memphis, Michigan, 38119
- Recruiting
Alkermes Investigational Site
North Canton, Ohio, 44720
- Recruiting
Alkermes Investigational Site
North Charleston, South Carolina, 29405
- Recruiting
Alkermes Investigational Site
Orlando, Florida, 32801
- Recruiting
Alkermes Investigational Site
Tampa, Florida, 33634
About this study
Official title: A Phase 2, Randomized, Parallel-Group, Double-Blind, Study to Evaluate the Safety and Efficacy of ALKS 7290 Compared to Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder
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 tested
- ALKS 7290, Placebo
- Keywords
- ADHD, Attention Deficit Disorder with Hyperactivity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 7290Drug
ALKS 7290 tablets taken daily, orally, for 4 weeks
PlaceboDrug
Placebo capsule taken daily
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Not described Receives: Drug: ALKS 7290 |
| Dose Level 2 | Experimental | Not described Receives: Drug: ALKS 7290 |
| Dose Level 3 | Experimental | Not described Receives: Drug: ALKS 7290 |
| Placebo | Placebo comparator | Placebo capsule taken daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score
Measured: Baseline to Week 4
Secondary outcomes (2)
Change from Baseline to Week 4 in Clinical Global Impression- Severity (CGI-S) scale score
Measured: Baseline to Week 4
Incidence of treatment-emergent adverse events
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start10 Aug 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755410
- Sponsor's protocol ID
- ALKS 7290-201
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No