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NCT02083783 · ClinicalTrials.gov registry record · Phase 3
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study of Attention Deficit Disorder With Hyperactivity, sponsored by Tris Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
- 5
- Study locations
NCT02083783: Completed Phase 3 study of Attention Deficit Disorder With Hyperactivity, sponsored by Tris Pharma.
NCT02083783 is a Phase 3 study of Attention Deficit Disorder With Hyperactivity that has completed, run by Tris Pharma. The registered enrollment target is 108 participants, below the 350-participant average among 20 other Attention Deficit Disorder With Hyperactivity trials with a reported enrollment target (69% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02083783, a Phase 3 study of Attention Deficit Disorder With Hyperactivity, has completed, sponsored by Tris Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to determine whether TRI102 is effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.
Primary Outcome
Change from baseline in SKAMP-Combined Scores measured approximately 4 hours after dose (active or placebo). The SKAMP-Combined score is obtained by summing 13 assessment items, where each item is rated on a 7-point scale (0 = normal to 6 = maximal impairment). This gives an overall (combined) SKAMP Score of 0= normal to 78 which indicates maximal impairment. The endpoint is assessed as a change from baseline in the overall score on the 78-point scale.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG TRI102
Study Locations (5)
Texas
- Bayou City Research - Houston
- Westex Clinical Investigation - Lubbock
California
- Newport Beach Clinical Research Associates, Inc. - Newport Beach
Nevada
- Center for Psychiatry and Behavioral Medicine, Inc. - Las Vegas
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT02083783 record still lists
NCT02083783 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 350-participant average among 20 other Attention Deficit Disorder With Hyperactivity trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Attention Deficit Disorder With Hyperactivity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02083783 lists 5 locations in 4 states (Texas, California, Nevada).
Frequently Asked Questions
What is clinical trial NCT02083783 about?
NCT02083783 is a clinical study titled "TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)". The purpose of this study is to determine whether TRI102 is effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.
What is the current status of trial NCT02083783?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2014-03. Estimated completion is 2014-12.
What conditions does trial NCT02083783 study?
This clinical trial studies the following conditions: Attention Deficit Disorder With Hyperactivity.
What interventions are being tested in trial NCT02083783?
The interventions under investigation include: Placebo (OTHER), TRI102 (DRUG).
Who is sponsoring clinical trial NCT02083783?
This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02083783 being conducted?
This trial has 5 study locations across California, Nevada, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Attention Deficit Disorder With Hyperactivity
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 NCT02083783's enrollment target sits among peer trials
108 10th of 20 higher than 11 of 20 other Attention Deficit Disorder With Hyperactivity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Disorder With Hyperactivity 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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