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Open-Label Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Center for Psychiatry and Behavioral Medicine, Las Vegas, NV
SPN-812Phase 4Waitlist AvailableResearch Sponsored by Supernus Pharmaceuticals, Inc.

Study Summary

This trialtests a drug to help treat ADHD in kids 6-17.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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The investigator determines that you have the appropriate level of intellectual functioning for your age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 5, 6, 7, and 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 5, 6, 7, and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AM dosing)
Incidence of adverse events (PM dosing)
Secondary outcome measures
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.
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.
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.
+19 more

Side effects data

From 2020 Phase 3 trial • 374 Patients • NCT04016779
16%
Insomnia
12%
Nausea
12%
Headache
12%
Fatigue
10%
Dry mouth
10%
Decreased appetite
6%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SPN-812

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Label TreatmentExperimental Treatment1 Intervention
Subjects 6-11 years of age: 100 to 400mg SPN-812 (100 mg oral capsule) Subjects 12-17 years of age: 100 to 600mg SPN-812 (100, 200 mg oral capsule)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPN-812
2010
Completed Phase 3
~430

Find a site

Who is running the clinical trial?

Supernus Pharmaceuticals, Inc.Lead Sponsor
44 Previous Clinical Trials
10,643 Total Patients Enrolled
17 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
5,170 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Jonathan Rubin, MD, MBAStudy Director
Chief Medical Officer
4 Previous Clinical Trials
575 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
160 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

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

What aim is this medical experiment attempting to realize?

"The primary outcome that will be evaluated over a 4 week period is the prevalence of adverse effects from PM dosage. Secondary outcomes include evaluation of Morning ADHD symptoms and Global assessment of severity of illness during AM dosing, as gauged by Parent-Rated ADHD Rating Scale, 5th Edition (PR-ADHD-RS-5) Total Score and Clinical Global Impression - Severity of Ilness (CGI-S) Scale respectively. The lower scores in both cases indicate more positive results."

Answered by AI

How many individuals can enroll in this clinical investigation?

"Affirmative. Clinicaltrials.gov's records demonstrate that this health research trial, which was first advertised on July 27th 2021, is searching for applicants now. 60 participants will be accepted at one medical institution."

Answered by AI

Is enrollment for this clinical experiment open at the moment?

"The clinical trial is currently enrolling, with initial postings made on July 27th 2021 and the most recent update occurring October 26th 2022. This information can be sourced from clinicaltrials.gov."

Answered by AI

To whom is this scientific research open?

"This trial is attempting to recruit sixty children and adolescents, aged between six and seventeen years old, suffering from Attention Deficit Disorder (ADD). Applicants must meet the following criteria: Be taking a single psychostimulant medication for ADD with an inadequate response as defined by investigator-rated ADHD-RS-5 Total score ≥24 and CGI-S score ≥3; be male or female aged 6 -17 at screening; have lived in same residence for past 6 months prior to screening; confirmed diagnosis of ADD through Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID); remain on stable psychost"

Answered by AI

Has the Open-Label Treatment been validated by the FDA?

"Taking into account that this treatment is in its fourth phase of testing, our team at Power assigned a score of 3 to Open-Label Treatment's safety."

Answered by AI

Are seniors eligible to participate in this experiment?

"This research project is seeking individuals between the ages of 6 and 17 years old."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
How old are they?
18 - 65
What site did they apply to?
Center for Psychiatry and Behavioral Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD
2021. "Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04786990.
~19 spots leftby Sep 2024
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