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NCT03260205 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 199
- Enrollment target
NCT03260205: Completed Phase 3 study, sponsored by Shire.
NCT03260205 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 199 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03260205, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 199 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.
Primary Outcome
ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (v
Interventions
- DRUG Placebo
- DRUG SPD489 (Lisdexamfetamine dimesylate)
- DRUG SPD489
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2017-09-06 |
| Est. Completion | 2018-10-23 |
| Phase | Phase 3 |
What the finished NCT03260205 record still lists
NCT03260205 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03260205 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03260205 about?
NCT03260205 is a clinical study titled "Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)". The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.
What is the current status of trial NCT03260205?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2017-09-06. Estimated completion is 2018-10-23.
What interventions are being tested in trial NCT03260205?
The interventions under investigation include: Placebo (DRUG), SPD489 (Lisdexamfetamine dimesylate) (DRUG), SPD489 (DRUG).
Who is sponsoring clinical trial NCT03260205?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03260205's enrollment target sits among peer trials
199 1388th of 2000 higher than 612 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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