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โ† Trials
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A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)

RecruitingPhase 2Ages 18 Years - 65 YearsAllAlkermes, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ26 * CGI-S score โ‰ฅ 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.
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What it tests

  • ALKS 7290
  • Placebo
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Where

19 sites
Alkermes Investigational Site
Little Rock, United States
Alkermes Investigational Site
Chino, United States
Alkermes Investigator Site
Chino, United States
Alkermes Investigational Site
Clermont, United States
Alkermes Investigational Site
Jacksonville, United States
Alkermes Investigational Site
Lakeland, United States
Alkermes Investigational Site
Largo, United States
Alkermes Investigational Site
Maitland, United States

โ€ฆand 11 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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