Centanafadine for ADHD

Recruiting at 85 trial locations

Overseen By Otsuka Call Center

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Disqualifiers: Tourette's, Severe anxiety, Psychosis, Autism, MDD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

680 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have started, changed, or stopped psychological treatments for ADHD in the last 30 days, you may not be eligible to participate.

What data supports the effectiveness of the drug Centanafadine Hydrochloride for ADHD?

Research shows that Centanafadine, which affects brain chemicals like norepinephrine, dopamine, and serotonin, has been tested in adults with ADHD and found to be effective in improving symptoms in phase 2 and phase 3 studies. ^{1 2 3 4 5}

Is Centanafadine safe for treating ADHD in adults?

Centanafadine has been studied in adults with ADHD, and the research suggests it is generally safe, with studies focusing on its safety and tolerability. However, as with any medication, monitoring for side effects is important. ^{3 4 5 6 7}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive centanafadine once daily extended-release capsules for ADHD

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue treatment until all enrolled subjects in their age group reach the Week 52 visit

Treatment Details

Interventions

• Centanafadine Hydrochloride

Trial Overview 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.

Participant Groups

Group I: Centanafadine Hydrochloride Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials

271

Recruited

170,000+

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

Findings from Research

Centanafadine sustained-release (SR) significantly reduced ADHD symptoms in adults, with a mean decrease of 21.41 points on the ADHD Rating Scale-IV after 4 weeks of treatment in a phase 2a study with 41 participants.

The phase 2b study with 85 participants showed that centanafadine-SR was effective compared to placebo, with improvements seen as early as week 1, and was generally well tolerated at doses up to 400 mg, with only mild to moderate side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies. Wigal, SB., Wigal, T., Hobart, M., et al.[2022]

Centanafadine, a medication that inhibits the reuptake of norepinephrine, dopamine, and serotonin, has shown significant efficacy in reducing ADHD symptoms in adults, with notable improvements in the Adult ADHD Investigator Symptom Rating Scale after 42 days of treatment.

The studies demonstrated a low overall rate of treatment-emergent adverse events, indicating that centanafadine is generally safe, with only a slight increase in adverse events at higher doses and low incidences of serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder: Results of 2 Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Trials. Adler, LA., Adams, J., Madera-McDonough, J., et al.[2022]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

A study analyzing adverse events from nonstimulant ADHD medications (atomoxetine, clonidine, and guanfacine) found that common side effects include ineffectiveness (up to 14.15%), fatigue (8.93%), and somnolence (up to 10.16%).

Suicidal ideation was reported among users of all three medications, highlighting the importance of monitoring and educating patients about potential serious side effects, even though they occur less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration. Pang, L., Sareen, R.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I, double-blind, randomized, placebo-controlled, dose-escalation study of the effects on blood pressure of abrupt cessation versus taper down of guanfacine extended-release tablets in adults aged 19 to 24 years. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Guanfacine and secondary mania in children. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Guanfacine for attention deficit and hyperactivity disorder in pediatrics: a systematic review and meta-analysis. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder: Results of 2 Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Trials. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration. [2021]