Open-Label Treatment for Attention Deficit Disorder

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Attention Deficit Disorder+2 More
SPN-812 - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Attention Deficit Disorder
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Attention Deficit Disorder

Study Objectives

2 Primary · 22 Secondary · Reporting Duration: Weeks 5, 6, 7, and 8

8 Weeks
Incidence of adverse events (AM dosing versus PM dosing)
Week 4
Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms during AM dosing of SPN-812 as measured by the Investigator-rated ADHD Rating Scale, 5th Edition (IR-ADHD-RS-5). The Total Score ranges from 0 and 54. Lower scores represent a better outcome.
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.
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.
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.
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.
Attention deficit hyperactivity disorder
Morning ADHD symptoms versus 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.
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 8
Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms during PM dosing of SPN-812 as measured by the Investigator-rated ADHD Rating Scale, 5th Edition (IR-ADHD-RS-5). The Total Score ranges from 0 and 54. Lower scores represent a better outcome.
Evening ADHD symptoms during PM 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.
Global assessment of severity of illness during PM 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.
Home functioning in the morning and evening during PM 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.
Morning ADHD symptoms during PM 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.
Morning ADHD symptoms versus Evening ADHD symptoms during PM 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.
Sleep during PM 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.
The Global assessment of improvement during PM 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 1
Incidence of adverse events (AM dosing)
Weeks 4 and 8
ADHD symptoms during AM dosing of SPN-812 versus PM dosing of SPN-812 as measured by the Investigator-rated ADHD Rating Scale, 5th Edition (IR-ADHD-RS-5). The Total Score ranges from 0 and 54. Lower scores represent a better outcome.
Global assessment of improvement during AM dosing of SPN-812 versus PM 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.
Mental disorders
Home functioning during AM dosing of SPN-812 versus PM dosing of SPN-812 as measured by the WPREMB-R Total score and Subscale scores. The Total score ranges between 0 and 33; higher scores indicates worse outcome.
Sleep during AM dosing of SPN-812 versus PM dosing of SPN-812 as measured by the 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 5
Incidence of adverse events (PM dosing)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Attention Deficit Disorder

Side Effects for

SPN-812
16%Insomnia
12%Nausea
12%Headache
12%Fatigue
10%Dry mouth
10%Decreased appetite
6%Constipation
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT04016779) in the SPN-812 ARM group. Side effects include: Insomnia with 16%, Nausea with 12%, Headache with 12%, Fatigue with 12%, Dry mouth with 10%.

Trial Design

1 Treatment Group

Open-Label Treatment
1 of 1
Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Open-Label Treatment · No Placebo Group · Phase 4

Open-Label Treatment
Drug
Experimental Group · 1 Intervention: SPN-812 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPN-812
2010
Completed Phase 3
~430

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 5, 6, 7, and 8

Who is running the clinical trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor
43 Previous Clinical Trials
8,143 Total Patients Enrolled
Jonathan Rubin, MD, MBAStudy DirectorChief Medical Officer
4 Previous Clinical Trials
575 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

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.
You are 6 to ≤17 years of age.
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).
You have a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation).
You are intellectually functioning at an age-appropriate level.
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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Nevada100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Center for Psychiatry and Behavioral Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%