Trial · NCT02083783
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
NCT02083783, Phase 3, Completed, Tris Pharma, Inc.; results first posted 2020-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD). Trials, record NCT02083783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02083783
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
- NCT number
- NCT02083783
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- Tris Pharma, Inc.
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- TRI102, Placebo
- First posted
- 2014-03-11
- Last updated
- 2020-08-26
- Results first posted
- 2020-08-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) | Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose | 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. |
| Secondary | PERMP (Permanent Product Measure of Performance). | Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose. | The PERMP is a math test that measures effortful performance without a learning curve (Wigal and Wigal 2006). The test determines the number of problems attempted and the number of problems correctly answered. In this study, the primary efficacy measure was a PERMP evaluation done 4 hours after taking study medication, a time selected a priori to coincide with the known pharmacodynamic effects based on prior research and to minimize the impact of repeated measures on adjustment of multiplicity (Wigal et al. 1998; Pelham et al. 2001). The PERMP consists of 400 math questions and each are scored. PERMP scores are expressed as the number of questions correct. Predose PERMP Tests are compared with post-dose PERMP scores at prespecfied timepoints. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) | Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose | Intention to treat population | score on a scale | MEAN |
| SECONDARY | PERMP (Permanent Product Measure of Performance). | Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose. | Intention to treat | PERMP questions answered correctly | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) | TRI102 | -9.1 | Standard Deviation 7.51 | score on a scale | |
| SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) | Placebo | 5.6 | Standard Deviation 7.85 | score on a scale | |
| PERMP (Permanent Product Measure of Performance). | TRI102 | 25.3 | Standard Error 4.21 | PERMP questions answered correctly | |
| PERMP (Permanent Product Measure of Performance). | Placebo | -13.6 | Standard Error 4.39 | PERMP questions answered correctly |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TRI102 | 52 | |
| Overall Study | STARTED | Placebo | 48 | |
| Overall Study | COMPLETED | TRI102 | 51 | |
| Overall Study | COMPLETED | Placebo | 48 | |
| Overall Study | NOT COMPLETED | TRI102 | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain, upper | Gastrointestinal disorders | TRI102 | 2 | 52 | 2 |
| other | Abdominal pain, upper | Gastrointestinal disorders | Placebo | 1 | 48 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | TRI102 | 2 | 52 | 2 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 48 | 0 |
| other | Rhinitis, allergic | Respiratory, thoracic and mediastinal disorders | TRI102 | 2 | 52 | 2 |
| other | Rhinitis, allergic | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 48 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TRI102 | 0 | 52 |
| Total, all-cause mortality | Placebo | 0 | 48 |
| Total, other adverse events | TRI102 | 6 | 52 |
| Total, other adverse events | Placebo | 1 | 48 |
| Total, serious adverse events | TRI102 | 0 | 52 |
| Total, serious adverse events | Placebo | 0 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36730749 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TRI102 vs Placebo: deaths from any cause | Trial comparisons |
| TRI102 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02083783
GET https://conductscience.org/api/trials/v1/NCT02083783/registered