Clinical Trials in the USA / NCT07755410
Recruiting
Phase 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)
NCT07755410 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Attention Deficit Disorder With Hyperactivity (ADHD)
Investigational drug(s) / intervention(s)
ALKS 7290 →Placebo
ALKS 7290: ALKS 7290 tablets taken daily, orally, for 4 weeks
Placebo: Placebo capsule taken daily
Study 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
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.
Primary outcome measure(s)
- Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score — Baseline to Week 4
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Alkermes Investigational Site | Little Rock | Arkansas | Recruiting |
| Alkermes Investigational Site | Chino | California | Recruiting |
| Alkermes Investigator Site | Chino | California | Recruiting |
| Alkermes Investigational Site | Clermont | Florida | Recruiting |
| Alkermes Investigational Site | Jacksonville | Florida | Recruiting |
| Alkermes Investigational Site | Lakeland | Florida | Recruiting |
| Alkermes Investigational Site | Largo | Florida | Recruiting |
| Alkermes Investigational Site | Maitland | Florida | Recruiting |
| Alkermes Investigator Site | Maitland | Florida | Recruiting |
| Alkermes Investigational Site | Maitland | Florida | Recruiting |
| Alkermes Investigational Site | Orange City | Florida | Recruiting |
| Alkermes Investigational Site | Orlando | Florida | Recruiting |
| Alkermes Investigational Site | Tampa | Florida | Recruiting |
| Alkermes Investigational Site | Decatur | Georgia | Recruiting |
| Alkermes Investigational Site | Foxborough | Massachusetts | Recruiting |
| Alkermes Investigational Site | Watertown | Massachusetts | Recruiting |
| Alkermes Investigational Site | Detroit | Michigan | Recruiting |
| Alkermes Investigational Site | Memphis | Michigan | Recruiting |
| Alkermes Investigational Site | Lincoln | Nebraska | Recruiting |
| Alkermes Investigational Site | Las Vegas | Nevada | Recruiting |
| Alkermes Investigational Site | Las Vegas | Nevada | Recruiting |
| Alkermes Investigational Site | North Canton | Ohio | Recruiting |
| Alkermes Investigational Site | East Providence | Rhode Island | Recruiting |
| Alkermes Investigational Site | North Charleston | South Carolina | Recruiting |
| Alkermes Investigational Site | Austin | Texas | Recruiting |
| Alkermes Investigational Site | Austin | Texas | Recruiting |
| Alkermes Investigational Site | The Woodlands | Texas | Recruiting |
| Alkermes Investigational Site | Bellevue | Washington | Recruiting |
More Alkermes, Inc. trials in the USA
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Enrolling by invitation
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07755410 on ClinicalTrials.gov ↗ ← All trials in the USA