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NCT04786990 · ClinicalTrials.gov registry record · Phase 4
Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD
A Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 96
- Enrollment target
- 17
- Study locations
NCT04786990: Completed Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Supernus Pharmaceuticals.
NCT04786990 is a Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 96 participants, below the 136-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (29% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04786990, a Phase 4 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 96 participants
- Enrollment target
- 17
- Study locations
Study Summary
This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).
Primary Outcome
The percent of subjects who took at least one dose of SPN-812 and reported at least one adverse event during 8 weeks of adjunct SPN-812 Treatment. The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and then multiplying the product by 100. The higher the percent, the higher the incidence.
Conditions Studied
Interventions
- DRUG SPN-812
Study Locations (17)
Florida
- Miami Clinical Research - Miami
- APG Research, LLC - Orlando
Idaho
- Elite Clinical Trials - Blackfoot
- Elite Clinical Trials - Rexburg
Texas
- Gadolin Research, LLC - Beaumont
- Family Psychiatry of The Woodlands - The Woodlands
Arkansas
- Preferred Research Partners, Inc. - Little Rock
California
- NRC Research Institute - Orange
Indiana
- Qualmedica Research, LLC - Evansville
Kansas
- Psychiatric Associates Purehealth Medical Center - Overland Park
Missouri
- Midwest Research Group - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2021-07-27 |
| Est. Completion | 2023-07-26 |
| Phase | Phase 4 |
What the finished NCT04786990 record still lists
NCT04786990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 136-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 1 intervention - of which SPN-812 is the first listed.
NCT04786990 lists 17 locations in 14 states (Florida, Idaho, Texas).
Frequently Asked Questions
What is clinical trial NCT04786990 about?
NCT04786990 is a clinical study titled "Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD". This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).
What is the current status of trial NCT04786990?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 96 participants. The study started on 2021-07-27. Estimated completion is 2023-07-26.
What conditions does trial NCT04786990 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD).
What interventions are being tested in trial NCT04786990?
The interventions under investigation include: SPN-812 (DRUG).
Who is sponsoring clinical trial NCT04786990?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04786990 being conducted?
This trial has 17 study locations across Arkansas, California, Florida, Idaho, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04786990's enrollment target sits among peer trials
96 10th of 18 higher than 9 of 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder (ADHD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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