Attention Deficit Disorder With Hyperactivity study: ALKS
Official title A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
ClinicalTrials.gov ID: NCT07755410
What this study is testing
What is ALKS 7290?
ALKS 7290 is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for attention deficit disorder with hyperactivity (adhd).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ALKS 7290 tablets are safe and help reduce ADHD symptoms compared to a pretend treatment.
- Who it's for
- You may be able to join if you are an adult with ADHD and meet the study’s health criteria.
- What's involved
- You will take ALKS 7290 tablets or a placebo tablet, and the study team will check your health and symptoms during visits.
- Time commitment
- The study lasts several weeks, with regular visits to give tablets and report how you feel.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Meets the Diagnostic and Statistical Manual of Mental Disorders -5 criteria for ADHD, as confirmed by the Mini-International Neuropsychiatric...
- Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- AISRS total score of ≥26
- CGI-S score ≥ 4 (moderately ill or worse)
- Has a Body Mass Index within 18 to 35 kg/m2
You likely can't join if
- Has a known history of intellectual developmental disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with...
- Has any of the following psychiatric conditions per the DSM-5 criteria, as assessed by the MINI.
- Clinically significant cognitive difficulties including dementia, delirium or amnestic syndromes, or any other cognitive disorder present with the...
- Moderate to severe substance use disorder according to DSM-5 guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit...
- Any other psychiatric condition that could interfere with participation in the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Chino, California, United States
- Clermont, Florida, United States
- Jacksonville, Florida, United States
- Lakeland, Florida, United States
- Largo, Florida, United States
- Maitland, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Decatur, Georgia, United States
- Foxborough, Massachusetts, United States
- Watertown, Massachusetts, United States
- Detroit, Michigan, United States
- Memphis, Michigan, United States
- Lincoln, Nebraska, United States
- Las Vegas, Nevada, United States
- North Canton, Ohio, United States
- East Providence, Rhode Island, United States
- North Charleston, South Carolina, United States
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Little Rock, Arkansas, United States; Chino, California, United States; Clermont, Florida, United States; Jacksonville, Florida, United States; Lakeland, Florida, United States; Largo, Florida, United States and 17 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.