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NCT02466425 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 264
- Enrollment target
- 20
- Study locations
NCT02466425: Completed Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Shire.
NCT02466425 is a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Shire. The registered enrollment target is 264 participants, above the 127-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02466425, a Phase 3 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 264 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.
Primary Outcome
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SHP465
Study Locations (20)
Florida
- Florida Clinical Research Center, Llc - Bradenton
- Sarkis Clinical Trials - Gainesville
- Clinical Neuroscience Solutions, Inc. - Jacksonville
- Medical Research Group of Central Florida - Orange City
- Clinical Neuroscience Solutions, Inc. - Orlando
- Miami Research Associates, Llc - South Miami
- Janus Center For Psychiatric Research - West Palm Beach
California
- Nrc Research Institute - Orange
- Pcsd Feighner Research - San Diego
- Encompass Clinical Research - Spring Valley
- Elite Clinical Trials, Inc - Wildomar
Illinois
- Capstone Clinical Research - Libertyville
- Baber Research Group Inc - Naperville
Alabama
- Harmonex Neuroscience Research - Dothan
Colorado
- McB Clinical Research Centers - Colorado Springs
Georgia
- Northwest Behavioral Research Center - Marietta
Kansas
- Psychiatric Associates - Overland Park
Louisiana
- Louisiana Research Associates, Inc - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2015-06-18 |
| Est. Completion | 2016-02-16 |
| Phase | Phase 3 |
What the finished NCT02466425 record still lists
NCT02466425 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, above the 127-participant average among 18 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (108% higher).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder (ADHD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02466425 names 20 study sites across 10 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT02466425 about?
NCT02466425 is a clinical study titled "Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)". The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children ...
What is the current status of trial NCT02466425?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2015-06-18. Estimated completion is 2016-02-16.
What conditions does trial NCT02466425 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD).
What interventions are being tested in trial NCT02466425?
The interventions under investigation include: Placebo (DRUG), SHP465 (DRUG).
Who is sponsoring clinical trial NCT02466425?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02466425 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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 NCT02466425's enrollment target sits among peer trials
264 4th of 18 higher than 15 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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