Centanafadine for ADHD

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial aims to test the safety and tolerability of a daily ADHD medication in children and teens aged 4-17. The medication releases its effects slowly over the day to help manage symptoms consistently. HLD200 is a form of methylphenidate designed to provide benefits from morning until evening.

Eligibility Criteria

This trial is for children and adolescents aged 4 to 17 with ADHD who completed a previous double-blind study. They must have an ADHD diagnosis, significant symptoms, and in some cases, inadequate response to psychotherapy. Excluded are those with certain severe psychiatric conditions or history of drug-related skin reactions.

Inclusion Criteria

My ADHD symptoms score is 28 or higher.

You have a score of 4 or higher on a test that measures symptoms of attention deficit hyperactivity disorder (ADHD).

I am between 4 and 17 years old.

+9 more

Exclusion Criteria

You have certain mental health conditions like Tourette's Disorder, severe anxiety, panic disorder, conduct disorder, psychosis, post-traumatic stress disorder, bipolar disorder, autism spectrum disorder, binge eating disorder, anorexia, bulimia, oppositional defiant disorder, or severe obsessive-compulsive disorder. If you have major depressive disorder, you either had treatment within the last 6 months or may require treatment during the trial.

You have a history of suicide attempts or current thoughts of harming yourself.

I am not pregnant or breastfeeding.

+5 more

Participant Groups

The trial tests the long-term safety of Centanafadine Hydrochloride, taken once daily as an extended-release (XR) medication for treating ADHD in pediatric patients. It follows up on participants from a prior study to assess tolerability over a longer period.

1Treatment groups

Experimental Treatment

Group I: Centanafadine HydrochlorideExperimental Treatment1 Intervention

* Adolescents (13 to 17 years of age, inclusive) to receive 328.8 mg daily. * Children (4 to 12 years of age, inclusive) will receive weight-based doses of centanafadine ranging from 82.2 mg to 328.8 mg daily