Frontlight ResearchEarly access
Taking people in United StatesPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Key facts
- Who runs it
- Alkermes, Inc.
- Where
- Austin, Bellevue, Chino, Clermont, Decatur, Detroit, East Providence, Foxborough, Jacksonville, Lakeland, Largo, Las Vegas, Lincoln, Little Rock, Maitland, Memphis, North Canton, North Charleston, Orange City, Orlando, Tampa, The Woodlands, and Watertown, United StatesSee the 25 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 312 people, planned
- Started
- 10 Aug 2026
- Expected to end
- Jul 2027
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ALKS 7290
- Placebo
- Record updated
- 29 October 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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 take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- Austin, TexasHospital not named in the registryContact: Global Clinical ServicesTaking people
- Bellevue, WashingtonHospital not named in the registryContact: Global Clinical ServicesTaking people
- Chino, CaliforniaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Chino, CaliforniaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Clermont, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Decatur, GeorgiaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Detroit, MichiganHospital not named in the registryContact: Global Clinical ServicesTaking people
- East Providence, Rhode IslandHospital not named in the registryContact: Global Clinical ServicesTaking people
- Foxborough, MassachusettsHospital not named in the registryContact: Global Clinical ServicesTaking people
- Jacksonville, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Lakeland, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Largo, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Las Vegas, NevadaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Lincoln, NebraskaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Little Rock, ArkansasHospital not named in the registryContact: Global Clinical ServicesTaking people
- Maitland, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Maitland, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Memphis, MichiganHospital not named in the registryContact: Global Clinical ServicesTaking people
- North Canton, OhioHospital not named in the registryContact: Global Clinical ServicesTaking people
- North Charleston, South CarolinaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Orange City, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Orlando, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- Tampa, FloridaHospital not named in the registryContact: Global Clinical ServicesTaking people
- The Woodlands, TexasHospital not named in the registryContact: Global Clinical ServicesTaking people
- Watertown, MassachusettsHospital not named in the registryContact: Global Clinical ServicesTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Dose Level 1Treatment being tested
Treatment: ALKS 7290
- Dose Level 2Treatment being tested
Treatment: ALKS 7290
- Dose Level 3Treatment being tested
Treatment: ALKS 7290
- PlaceboPlacebo, for comparison
Placebo capsule taken daily
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Fit questions
- Built from NCT07755410, who can take part
- Record updated
- 29 October 2026