Centanafadine for Attention Deficit Disorder

1
Effectiveness
1
Safety
For additional information regarding sites, contact 844-687-8522, Oklahoma City, OK
Attention Deficit Disorder+2 More
Centanafadine - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Attention Deficit Disorder

Study Summary

This study is evaluating whether a drug called LYNPARZA may help improve symptoms of attention deficit hyperactivity disorder in children.

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Eligible Conditions

  • Attention Deficit Disorder
  • Attention Deficit Disorder with Hyperactivity
  • Hyperkinesis
  • Attention-deficit Hyperactivity Disorder

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Centanafadine will improve 3 primary outcomes in patients with Attention Deficit Disorder. Measurement will happen over the course of 24 hours.

24 hours
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Maximal peak plasma concentration (Cmax)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Open-label centanafadine

This trial requires 38 total participants across 2 different treatment groups

This trial involves 2 different treatments. Centanafadine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Open-label centanafadine
Drug
There will be multiple cohorts dosed with open-label centanafadine.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 hours for reporting.

Closest Location

For additional information regarding sites, contact 844-687-8522 - Oklahoma City, OK

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This text is saying that if a person has ADHD and it is confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents, then it is considered to be a diagnosis of ADHD subtype. show original
Subjects aged 4 to 12 years, both male and female, who have given consent/assent. show original
Key

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for attention deficit disorder?

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Children and adults should not be denied treatment for ADHD because of lack of economic means or lack of expertise in behavioral counseling. Instead, it should be assessed for severity. The American Academy of Pediatrics and the American Speech-Language-Hearing Association recommend a multidisciplinary approach for treating ADHD, and a comprehensive evaluation must include parental counseling. If a child appears to be overreacting, he or she may benefit from one or more psychopharmacological or behavioral treatments. In all children with ADHD or other comorbid disorders, behavioral training is indicated. Finally, parents and teachers must be appropriately trained and equipped to intervene if child's behavior is interfering with academic or social life.

Unverified Answer

What causes attention deficit disorder?

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A large body of evidence indicates that the etiology of ADHD is extremely heterogeneous, and the number and type of subtypes is likely variable, depending on the researcher. Inappropriate and excessive behavioral activation in the home environment during the toddler phase is hypothesized to be a common pathogenic factor in ADHD.

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How many people get attention deficit disorder a year in the United States?

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Around 13.5 million children in the United States will be diagnosed with ADHD at some point in their lifetime. Children with ADHD face many challenges in their school and family environments and therefore represent a group for whom early intervention is vital.

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Can attention deficit disorder be cured?

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Data from a recent study suggests that ADHD is a disorder associated with the occurrence of a psychiatric disease. ADHD is frequently associated with other disorders. The course of psychiatric disorders, the duration of the disease, and the degree of severity of psychiatric complaints can be reduced by the administration of a stable dose of a mood stabilizer. We therefore believe that pharmacological treatment of ADHD could, to some extent, be an effective way to lessen the burden associated with psychiatric disorders.

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What is attention deficit disorder?

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Attention deficit hyperactivity disorder is a highly comorbid disorder that often emerges in patients with co-existing clinical psychiatric conditions and is often associated with mood, anxiety, and sleep disturbances. It is critical for clinicians to understand that common co-existing conditions include disorders that share clinical and genetic relationships with ADHD and co-occur in the general adult population. The need for greater recognition of ADHD symptoms in patients with other psychiatric disorders will enhance optimal management of these disorders.

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What are the signs of attention deficit disorder?

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Signs of attention deficit disorder include a failure to follow directions properly, difficulty completing tasks at all, rapid talking, impulsivity, distractibility and poor coordination. These signs generally appear before the age of 5 years. Symptoms of AD/HD may be not or partially not present in early childhood. Adult onset of ADHD may have symptoms that overlap with the signs of AD/HD.\n

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Who should consider clinical trials for attention deficit disorder?

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Attention deficit disorder is a highly prevalent disorder among boys and girls and young adults. As a result, research in pharmacological interventions for ADHD is warranted in this age group.

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Has centanafadine proven to be more effective than a placebo?

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In the short term, centanafadine did not demonstrate a statistically significant improvement in ADHD symptomatology over a placebo; however, a statistically significant long-term improvement was observed. When centanafadine was used as a once-daily 40-mg maintenance dose, no reduction in its use or no rebound effect was observed after 48 weeks of treatment. In children aged 6 to 17 years undergoing centanafadine treatment, no increase in reported agitation or other adverse side effects was observed relative to a placebo. Centanafadine did not affect the frequency of medication-experienced sleep episodes.

Unverified Answer

What is the average age someone gets attention deficit disorder?

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The age at onset of ADHD appears to be about age 8. There is about a 20 percent risk of ADHD for each year after age 7. Atypical diagnoses are common; comorbidity is common, even with classic ADHD. There is evidence for a genetic component in ADHD.

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What are the common side effects of centanafadine?

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centanafadine is generally well tolerated. Some common (more than 1% of patients) and uncommon (less than 1% of patients) AEs included upper respiratory infection, headache, dizziness, gastrointestinal problems (such as nausea, vomiting, and dry mouth), and constipation. The most common AEs (more than 1% of patients with at least 10% of patients experiencing it) included malaise, fatigue, diarrhea, and insomnia. Patients should be advised that centanafadine should not be used concomitantly with anticoagulants. Patients should also be advised that centanafadine should not be used for more than 4 weeks.

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What does centanafadine usually treat?

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At the doses used in these patients, centanafadine provided effective and sustained relief of core ADHD symptoms and a high rate of patient and parent satisfaction, without side effects.

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What is the latest research for attention deficit disorder?

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Evidence to support a causal relationship between ADHD and substance misuse is still weak. It's unclear whether stimulant medication has any measurable impact on the rate of substance misuse in individuals with ADHD. There is no agreement on the appropriate therapeutic approach to ADHD and substance misuse and as yet no evidence to suggest that specific ADHD treatments are more effective than other treatments and treatment options.

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