Centanafadine for ADHD

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, centanafadine, to assess its safety and tolerability for children and teens with ADHD. The medication aims to help those diagnosed with ADHD, a condition characterized by attention problems and hyperactivity. Participants should be children or teens with noticeable ADHD symptoms in daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that centanafadine hydrochloride is likely to be safe for humans?

Research has shown that centanafadine is generally safe and well-tolerated for treating ADHD. Studies have found that both children and teenagers taking centanafadine experienced improvements in their ADHD symptoms with a good safety record. Notably, earlier research highlighted that centanafadine, at doses similar to those used in adults, had a better short-term safety profile compared to other ADHD medications like lisdexamfetamine and atomoxetine.

Furthermore, these studies indicate that centanafadine carries a low risk of misuse, which is important for long-term safety. While some side effects might occur, data suggest these are usually mild. Overall, centanafadine appears to be well-tolerated in both children and teenagers with ADHD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ADHD?

Unlike the standard treatments for ADHD, which often include stimulants like methylphenidate or amphetamines, centanafadine offers a unique approach by targeting multiple neurotransmitter systems. Researchers are excited about centanafadine because it acts on norepinephrine, dopamine, and serotonin transporters, potentially offering a more balanced and comprehensive effect on ADHD symptoms. This multi-target mechanism could result in improved attention and focus with a potentially lower risk of side effects commonly associated with traditional stimulants.

What evidence suggests that centanafadine might be an effective treatment for ADHD?

Studies have shown that centanafadine hydrochloride can help reduce ADHD symptoms. In this trial, adolescents (13 to 17 years old) will receive a daily dose of 328.8 mg, which has proven especially effective. Children (4 to 12 years old) will receive weight-based doses ranging from 82.2 mg to 328.8 mg daily. Although centanafadine may not surpass all current ADHD treatments, it offers a promising option with a good safety record. Overall, research indicates that centanafadine is generally safe and well-tolerated. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Subjects who, during the double-blind parent trials, experienced, in the opinion of the investigator, poor tolerability to trial medication or whose safety assessments resulted in new concerns that would suggest the subject may not be appropriate for a 52-week treatment with trial medication.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0890856725003272

Centanafadine for Attention-Deficit/Hyperactivity Disorder ... Centanafadine 328.8 mg was efficacious for ADHD treatment in adolescents. Both doses were generally safe and well tolerated.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38824626/

Assessment of centanafadine in adults with attention-deficit ... Conclusions: In an anchored MAIC, centanafadine showed a significantly better short-term safety profile than lisdexamfetamine, atomoxetine, and viloxazine ER; ...

3. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.6.528

Assessment of centanafadine in adults with attention-deficit ... ADHD symptom improvement with centanafadine was smaller than with lisdexamfetamine dimesylate and nondifferent than with atomoxetine ...

4. publications.aap.org publications.aap.org/pediatricsopenscience/article/1/3/1/202430/Efficacy-and-Safety-of-Centanafadine-for-ADHD

Efficacy and Safety of Centanafadine for ADHD Treatment ... Once-daily doses of CTN resulting in plasma levels equivalent to the 400-mg daily adult dose improved ADHD symptoms in children aged 6 to 12 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03605836

NCT03605836 | A Trial to Evaluate the Efficacy, Safety, and ... This study evaluated the efficacy, safety, and tolerability of centanafadine sustained-release tablets in adults with ADHD. Participants either received a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9426730/

Efficacy, Safety, and Tolerability of Centanafadine ... Centanafadine has been shown to be safe and well tolerated, with a limited abuse potential across the clinical trial program, including in these ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05279313

Study Details | NCT05279313 | A Trial of Centanafadine ... This open-label study will assess the overall safety and tolerability of centanafadine once daily extended-release capsules in pediatric subjects (ages 4-17 ...