Attention Deficit Disorder With Hyperactivity
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGTRI102
formulation containing active moiety (amphetamine)
OTHERPlacebo
formulation without active moiety
Sponsors
Tris Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
8 subjects not randomized.
Participants by arm
| Arm | Count |
|---|---|
| TRI102 Active, amphetamine extended-release oral suspension
TRI102: formulation containing active moiety (amphetamine) | 51 |
| Placebo Placebo
Placebo: formulation without active moiety | 48 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo | TRI102 |
|---|---|---|---|
| ADHD Type Combined | 78 Participants | 39 Participants | 39 Participants |
| ADHD Type Predominantly impulsive | 1 Participants | 1 Participants | 0 Participants |
| ADHD Type Predominantly inattentive | 20 Participants | 8 Participants | 12 Participants |
| Age, Continuous | 9.4 Years STANDARD_DEVIATION 1.86 | 9.6 Years STANDARD_DEVIATION 1.76 | 9.2 Years STANDARD_DEVIATION 1.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 21 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 27 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 15 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 55 Participants | 28 Participants | 27 Participants |
| Sex: Female, Male Female | 31 Participants | 16 Participants | 15 Participants |
| Sex: Female, Male Male | 68 Participants | 32 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 48 |
| other Total, other adverse events | 6 / 52 | 1 / 48 |
| serious Total, serious adverse events | 0 / 52 | 0 / 48 |
Outcome results
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.
Time frame: Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose
Population: Intention to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TRI102 | SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) | -9.1 score on a scale | Standard Deviation 7.51 |
| Placebo | SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) | 5.6 score on a scale | Standard Deviation 7.85 |
Comparison: Treatment difference in SKAMP-C scores from baseline to 4 hours postdose.p-value: <0.000195% CI: [-17.9, 11.6]ANCOVA
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.
Time frame: Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose.
Population: Intention to treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TRI102 | PERMP (Permanent Product Measure of Performance). | 25.3 PERMP questions answered correctly | Standard Error 4.21 |
| Placebo | PERMP (Permanent Product Measure of Performance). | -13.6 PERMP questions answered correctly | Standard Error 4.39 |
Comparison: p-value for comparison between change from baseline in placebo vs active treatmentp-value: <0.000195% CI: [27.3, 50.6]ANCOVA