NCT07755410 A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
| NCT ID | NCT07755410 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alkermes, Inc. |
| Condition | Attention Deficit Disorder With Hyperactivity (ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2026-08 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 312 participants in total. It began in 2026-08 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Medical Director, MD
STUDY DIRECTOR
Alkermes, Inc.
Frequently Asked Questions
Who can join the NCT07755410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Attention Deficit Disorder With Hyperactivity (ADHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07755410 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07755410 currently recruiting?
Yes, NCT07755410 is actively recruiting participants. Contact the research team at clinicaltrials@alkermes.com for enrollment information.
Where is the NCT07755410 trial being conducted?
This trial is being conducted at Chino, United States, Maitland, United States.
Who is sponsoring the NCT07755410 clinical trial?
NCT07755410 is sponsored by Alkermes, Inc.. The principal investigator is Medical Director, MD at Alkermes, Inc.. The trial plans to enroll 312 participants.