Phase 3
N=100
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT02083783 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) — -9.1; 5.6 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TRI102 (Drug); Placebo (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Tris Pharma, Inc.
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) |
-9.1; 5.6 | <0.0001 sig |
| SECONDARY PERMP (Permanent Product Measure of Performance). |
25.3; -13.6 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition
Exclusion Criteria
- Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
Data sourced from ClinicalTrials.gov (NCT02083783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.