Attention Deficit Disorder With Hyperactivity (ADHD)Phase 2NCT07755410
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
A Phase 2 study testing ALKS 7290 in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by Alkermes, Inc. at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- ALKS 7290
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 19 sitesUnited States
- Study dates
- 10 Aug 2026to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
Alkermes Investigational Site
Austin, Texas, 78759
- Recruiting
Alkermes Investigational Site
Bellevue, Washington, 98007
- Recruiting
Alkermes Investigational Site
Chino, California, 91710
- Recruiting
Alkermes Investigator Site
Chino, California, 91710
- Recruiting
Alkermes Investigational Site
Clermont, Florida, 34711
- Recruiting
Alkermes Investigational Site
Decatur, Georgia, 30030
- Recruiting
Alkermes Investigational Site
East Providence, Rhode Island, 02914
- Recruiting
Alkermes Investigational Site
Jacksonville, Florida, 32256
- Recruiting
Alkermes Investigational Site
Lakeland, Florida, 33803
- Recruiting
Alkermes Investigational Site
Largo, Florida, 33777
- Recruiting
Alkermes Investigational Site
Little Rock, Arkansas, 72211
- Recruiting
Alkermes Investigational Site
Maitland, Florida, 32751
- Recruiting
Alkermes Investigator Site
Maitland, Florida, 32751
- Recruiting
Alkermes Investigational Site
Maitland, Florida, 98007
- Recruiting
Alkermes Investigational Site
Memphis, Michigan, 38119
- Recruiting
Alkermes Investigational Site
North Canton, Ohio, 44720
- Recruiting
Alkermes Investigational Site
North Charleston, South Carolina, 29405
- Recruiting
Alkermes Investigational Site
Orlando, Florida, 32801
- Recruiting
Alkermes Investigational Site
Tampa, Florida, 33634
About this study
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
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.
- Being tested
- ALKS 7290, Placebo
- Keywords
- ADHD, Attention Deficit Disorder with Hyperactivity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALKS 7290Drug
ALKS 7290 tablets taken daily, orally, for 4 weeks
PlaceboDrug
Placebo capsule taken daily
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Not described Receives: Drug: ALKS 7290 |
| Dose Level 2 | Experimental | Not described Receives: Drug: ALKS 7290 |
| Dose Level 3 | Experimental | Not described Receives: Drug: ALKS 7290 |
| Placebo | Placebo comparator | Placebo capsule taken daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score
Measured: Baseline to Week 4
Secondary outcomes (2)
Change from Baseline to Week 4 in Clinical Global Impression- Severity (CGI-S) scale score
Measured: Baseline to Week 4
Incidence of treatment-emergent adverse events
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start10 Aug 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755410
- Sponsor's protocol ID
- ALKS 7290-201
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07755410
- Acronym / sponsor ID
- ALKS 7290-201
- Keywords
- ADHD, Attention Deficit Disorder with Hyperactivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: ALKS 7290 |
| Dose Level 2 | Experimental | Drug: ALKS 7290 |
| Dose Level 3 | Experimental | Drug: ALKS 7290 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule taken daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALKS 7290ALKS 7290 tablets taken daily, orally, for 4 weeks | Drug | Dose Level 1, Dose Level 2, Dose Level 3 |
| PlaceboPlacebo capsule taken daily | Drug | Placebo |
Primary outcome
Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score
Time frame: Baseline to Week 4
2 secondary outcomes
Change from Baseline to Week 4 in Clinical Global Impression- Severity (CGI-S) scale score
Time frame: Baseline to Week 4
Incidence of treatment-emergent adverse events
Time frame: Up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director, MD study director
Alkermes, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALKS 7290 in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by Alkermes, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Global Clinical Services (888-235-8008 (US Only), clinicaltrials@alkermes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.