What side effects are associated with this type of intervention?

Common treatments for ADHD, such as stimulants (e.g., methylphenidate, amphetamines) and non-stimulants (e.g., atomoxetine), often have side effects including increased heart rate, elevated blood pressure, insomnia, decreased appetite, weight loss, and gastrointestinal issues like nausea. Atomoxetine, a selective norepinephrine reuptake inhibitor, can also cause mood swings and fatigue. While Centanafadine QD XR specifically is still under study, it is expected to have similar side effects due to its mechanism of increasing norepinephrine, dopamine, and serotonin levels.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate and amphetamines, which primarily increase dopamine and norepinephrine levels. Non-stimulant options include atomoxetine, a selective norepinephrine reuptake inhibitor, and guanfacine, an alpha-2 adrenergic agonist. While Centanafadine QD XR, a triple reuptake inhibitor that increases norepinephrine, dopamine, and serotonin levels, is still under investigation, it represents a novel approach compared to the currently approved treatments.

What other types of research exist?

Promising alternatives to Centanafadine QD XR for ADHD treatment include Guanfacine Extended Release (GXR) and Dexmethylphenidate Extended Release (DMPH). GXR has shown efficacy in reducing ADHD symptoms and is particularly noted for its benefits in children with comorbid conditions like oppositional defiant disorder. DMPH is another effective option, especially for its cardiovascular safety profile in long-term use.

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Norepinephrine-Dopamine Reuptake Inhibitor

Centanafadine for ADHD

Q: What is the mechanism of action of this treatment?

Common treatments for ADHD primarily include stimulant medications such as methylphenidate and amphetamines, which increase the levels of dopamine and norepinephrine in the brain, enhancing attention and reducing impulsivity and hyperactivity. Non-stimulant options like atomoxetine work by selectively inhibiting the reuptake of norepinephrine, thereby improving focus and behavior. Alpha-2 adrenergic agonists like guanfacine modulate noradrenergic tone, which can help with hyperactivity and impulsivity. Centanafadine, a triple reuptake inhibitor, increases the levels of norepinephrine, dopamine, and serotonin, potentially offering a broader spectrum of symptom control. These mechanisms are crucial for ADHD patients as they target the neurochemical imbalances associated with the disorder, thereby improving cognitive function and behavioral outcomes.

Phase 3

Recruiting

Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females aged 4 to 17 years (inclusive) at the time of informed consent/assent.

A primary diagnosis of ADHD based on DSM-5 diagnosis criteria as confirmed with the MINI-KID (for children and adolescents aged 4 to 17 years [inclusive]).

Must not have

Subjects who are breast-feeding and/or have a positive pregnancy test result prior to receiving IMP.

Body weight < 13 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, the focus is on evaluating any adverse reactions related to skin health due to past drug exposure and overall tolerability issues that may arise during prolonged use of Centanafadine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 17 years old.

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I have been diagnosed with ADHD according to DSM-5 criteria.

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My ADHD symptoms score is 28 or higher.

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I am between 4 and 17 years old.

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I have been diagnosed with ADHD according to DSM-5 criteria.

Select...

My ADHD symptoms score is 28 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breastfeeding.

Select...

My body weight is less than 13 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.

This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine long-term safety and tolerability of Centanafadine QD XR Capsules.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Centanafadine Hydrochloride

2022

Completed Phase 3

~460

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD primarily include stimulant medications such as methylphenidate and amphetamines, which increase the levels of dopamine and norepinephrine in the brain, enhancing attention and reducing impulsivity and hyperactivity. Non-stimulant options like atomoxetine work by selectively inhibiting the reuptake of norepinephrine, thereby improving focus and behavior. Alpha-2 adrenergic agonists like guanfacine modulate noradrenergic tone, which can help with hyperactivity and impulsivity. Centanafadine, a triple reuptake inhibitor, increases the levels of norepinephrine, dopamine, and serotonin, potentially offering a broader spectrum of symptom control. These mechanisms are crucial for ADHD patients as they target the neurochemical imbalances associated with the disorder, thereby improving cognitive function and behavioral outcomes.

Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies.