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PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing ALKS 7290 for Attention Deficit Disorder With Hyperactivity (ADHD)

This study wants to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with dummy treatment (placebo) tablets.

Official registry: https://clinicaltrials.gov/study/NCT07755410 · Alkermes, Inc. · enrollment listed as 312

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ALKS 7290, or Placebo. The registry lists allocation as randomized. This study wants to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with dummy treatment (placebo) tablets.

They plan to enroll about 312 people at 25 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ALKS 7290, Placebo

Primary outcome (registry wording): Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • 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

Public study contact (from the registry)

Global Clinical Services

888-235-8008 (US Only)

clinicaltrials@alkermes.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

25 listed

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FAQ about this NCT record

Is NCT07755410 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07755410?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07755410?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary