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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.
A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is taken once daily and subjects undergo dose optimization activities for 5 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRI102 | Experimental | Active, amphetamine extended-release oral suspension |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRI102 | Drug | formulation containing active moiety (amphetamine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) | 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. | Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose |
| Measure | Description | Time Frame |
|---|---|---|
| PERMP (Permanent Product Measure of Performance). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Wigal, PhD | Newport Beach Clinical Research Associates, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach Clinical Research Associates, Inc. | Newport Beach | California | 92660 | United States | ||
| Center for Psychiatry and Behavioral Medicine, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36730749 | Derived | Faraone SV, Childress AC, Gomeni R, Rafla E, Kando JC, Dansie L, Naik P, Pardo A. Efficacy of Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder: Effect Size Across the Day. J Child Adolesc Psychopharmacol. 2023 Feb;33(1):14-19. doi: 10.1089/cap.2022.0093. Epub 2023 Feb 2. |
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8 subjects not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | TRI102 | Active TRI102: formulation containing active moiety The stable dose of TRI102 reached during the Dose Optimization Period varied between 10 to 20 mg/day and was determined based on Investigator clinical judgment and assessments of both tolerability and efficacy for each subject. The same stable dose identified for a subject during the Dose Optimization Period was administered during the double-blind Treatment Period. |
| FG001 | Placebo | Placebo Placebo: formulation without active moiety The same stable dose identified for a subject during the Dose Optimization Period was administered during the double-blind Treatment Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | TRI102 | Active, amphetamine extended-release oral suspension TRI102: formulation containing active moiety (amphetamine) |
| BG001 | Placebo | Placebo Placebo: formulation without active moiety |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) | 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. | Intention to treat population | Posted | Mean | Standard Deviation | score on a scale | Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose |
|
Screening through Follow up (9 weeks)
AEs were recorded at each study visit for a total of 9 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TRI102 | Active, amphetamine extended-release oral suspension TRI102: formulation containing active moiety (amphetamine) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain, upper | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Pardo MD | Tris Pharma, Inc. | 732-823-4755 | apardo@trispharma.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C408432 | TRI102 protein, Gibberella zeae |
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| Placebo | Other | formulation without active moiety |
|
| Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose. |
| Las Vegas |
| Nevada |
| 89128 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Bayou City Research | Houston | Texas | 77007 | United States |
| Westex Clinical Investigation | Lubbock | Texas | 79423 | United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ADHD Type | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo Placebo: formulation without active moiety The same stable dose identified for a subject during the Dose Optimization Period was administered during the double-blind Treatment Period. |
|
|
|
| Secondary | PERMP (Permanent Product Measure of Performance). | 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. | Intention to treat | Posted | Least Squares Mean | Standard Error | PERMP questions answered correctly | Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose. |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 6 |
| 52 |
| EG001 | Placebo | Placebo Placebo: formulation without active moiety | 0 | 48 | 0 | 48 | 1 | 48 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinitis, allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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