CLINICAL TRIAL

SPN-812 for Attention Deficit Disorder

Recruiting · < 18 · All Sexes · Las Vegas, NV

This study is evaluating whether a drug called SPN-812 can be used to treat ADHD in children and adolescents.

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About the trial for Attention Deficit Disorder

Eligible Conditions
Attention Deficit Hyperactivity Disorder (ADHD) · Attention Deficit Disorder with Hyperactivity · Hyperkinesis

Treatment Groups

This trial involves 2 different treatments. SPN-812 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 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
SPN-812
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPN-812
2010
Completed Phase 2
~60

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are currently taking a single, stable psychostimulant regimen (see Inclusion Criterion 8 for definition) for treatment of ADHD with a partial, but inadequate efficacy response to at least 2 weeks of treatment with a psychostimulant (methylphenidate or amphetamine) prior to screening. show original
You are 6 to ≤17 years of age. show original
Parent(s)/legal guardian(s) is able to read and understand the Informed Consent Form (ICF).
Written informed consent obtained by parent(s)/legal guardian(s) and informed assent obtained from the subject, if applicable.
You are willing and able to comply with all of the procedures and requirements defined in the protocol, including parents(s)/legal guardian(s) oversight of morning and evening dosing of the study medication (SM). show original
Has lived with the same parent(s)/legal guardian(s) at same residence for at least the last 6 months prior to screening.
You have a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation). show original
Is currently and expecting to continue and remain on a stable psychostimulant regimen throughout the study. A stable stimulant regimen is defined as taking dose at least 5 days per week (morning) no significant change in dose or dosing frequency at least 2 weeks prior to baseline (Visit 2), and the investigator believes the subject's psychostimulant dose is optimized.
You are intellectually functioning at an age-appropriate level. show original
You are a child or adolescent (6-17 years of age) with a body weight of at least 20 kg or an adolescent (12-17 years of age) with a body weight of at least 35 kg. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Weeks 5, 6, 7, and 8
Screening: ~3 weeks
Treatment: Varies
Reporting: Weeks 5, 6, 7, and 8
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Weeks 5, 6, 7, and 8.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether SPN-812 will improve 2 primary outcomes and 22 secondary outcomes in patients with Attention Deficit Disorder. Measurement will happen over the course of Week 4.

Sleep during AM dosing of SPN-812 as measured by the Sleep Disturbance Scale for Children (SDSC). The raw Total score ranges from 26 to 130 converted to T-score. A T-score >70 (>95th percentile) is indicative of a clinically significant sleep problem.
WEEK 4
Change from baseline in the Sleep Disturbance Scale for Children (SDSC) Total score and Subscale scores at Week 4.
WEEK 4
Home functioning in the morning and evening during AM dosing of SPN-812 as measured by the Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R). The Total score ranges between 0 and 33; higher scores indicates worse outcome.
WEEK 4
Change from baseline in the Weekly Parent Rating of Evening and Morning Behavior-Revised (WPREMB-R) Total score and Subscale scores at Week 4.
WEEK 4
Evening ADHD symptoms during AM dosing of SPN-812 as measured by the Parent-Rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5). The Total Score ranges from 0 and 54. Lower scores represent a better outcome.
WEEK 4
Change from baseline in the "Evening" Parent-Rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total score at Week 4. The Total Score ranges from 0 and 54. Lower scores represent a better outcome.
WEEK 4
Global assessment of severity of illness during AM dosing of SPN-812 as measured by the Clinical Global Impression - Severity of Ilness (CGI-S) Scale. A lower CGI-S score [1=Normal, not at all ill to 7=Extremely Ill] indicates better outcome.
WEEK 4
Change from baseline in the Clinical Global Impression - Severity of Ilness (CGI-S) Scale Score at Week 4.
WEEK 4
Morning ADHD symptoms during AM dosing of SPN-812 as measured by the Parent-Rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5). The Total Score ranges from 0 and 54. Lower scores represent a better outcome.
WEEK 4
Change from baseline in the "Morning" Parent-Rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total score at Week 4.
WEEK 4
Global assessment of improvement during AM dosing of SPN-812 as measured by the Clinical Global Impression - Improvement (CGI-I) Scale.A lower CGI-I score [1=Very much improved to 7=Very much worse] indicates better outcome.
WEEK 4
The Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 4.
WEEK 4
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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 is attention deficit disorder?

The term 'attention deficit disorder' used frequently by general practitioners, is a misnomer, given the limited and inconsistent clinical features of the disorder, and the lack of a clear diagnostic criterion. Attention-deficit is best described by a concept of attentional dis-regulation.

Anonymous Patient Answer

Can attention deficit disorder be cured?

Attention deficits cannot be cured, but the impact of one's attention deficit behaviors on one's ability to perform activities of daily living can be reduced through remediation strategies. In some cases, attention deficit behavior can even be improved (via one-on-one coaching and supervised treatment), without any major or lasting long-term impairment; thus, attention deficit disorder could possibly be treated.

Anonymous Patient Answer

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

Most individuals with an ADHD subtype are in child or early adolescent years. However, the increase in subtypes over time should be expected to result in increased numbers of individuals with ADHD.

Anonymous Patient Answer

What are the signs of attention deficit disorder?

There are many signs and symptoms of ADHD. Symptoms include being inattentive, distractible, hyperactive, impulsive and inattentive. Inattention can make up for the inattentive symptoms by making the hyperactive and impulsive symptoms worse. theme: nevi"

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Anonymous Patient Answer

What causes attention deficit disorder?

The causes of ADHD are multifactorial and are affected by genetic and environmental factors. The occurrence of ADHD increases with age, and a higher proportion of men with ADHD have symptoms of other psychiatric disorders. There is no evidence that ADHD is caused by physical damage to the brain.

Anonymous Patient Answer

What are common treatments for attention deficit disorder?

A variety of over-the-counter and prescribed treatments are employed by clinicians to treat people diagnosed with this disorder. Some medications are commonly prescribed to treat many different psychiatric and neurological conditions, however.

Anonymous Patient Answer

What are the latest developments in spn-812 for therapeutic use?

SPN-812 has shown good efficacy in an animal model, and it may be effective in humans, but a safety issues is needed to be studied before it can be introduced as a treatment for ADHD or ADHD-like symptomology.

Anonymous Patient Answer

How does spn-812 work?

Spn-812 was safe, tolerable, and effective and therefore warranting further exploration for the treatment of comorbid ADHD and anxiety in adults with ADHD. The study was limited in that the control group did not have ADHD.

Anonymous Patient Answer

Who should consider clinical trials for attention deficit disorder?

Children and adolescents may require more intensive psychiatric diagnosis that will improve understanding of their psychiatric disorders, especially ADHD. Many patients with ADHD continue with medications, though there is no clear evidence that the medications are justified in preventing relapse in those with ADHD. Results from a recent paper imply that the efficacy of medications for ADHD may be a matter of continuing treatment for an initial diagnosis of ADHD and subsequent continuation of treatment.

Anonymous Patient Answer

How serious can attention deficit disorder be?

The data on comorbidity among the students is compellingly relevant. Attention deficit disorder is the most frequently reported disorder among students. It is important for physicians to be aware of the fact that students are at risk for an attention deficit disorder as well.

Anonymous Patient Answer

Have there been other clinical trials involving spn-812?

The evidence currently suggests that spn-812 could be useful by decreasing prolactin levels when given to patients with AD due to its central dopaminergic effects in the CNS. However, it would be advantageous to further research the therapeutic effects of the drug before using it in patients with PD.

Anonymous Patient Answer

Has spn-812 proven to be more effective than a placebo?

In a recent study, findings has shown that spn-812 has beneficial effects in children in attention deficit hyperactivity disorder (ADHD), and may be a more effective drug than placebo.

Anonymous Patient Answer
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