Trial Outcomes & Findings for TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT02083783)

NCT ID: NCT02083783

Last Updated: 2020-08-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 108 participants
• Primary outcome timeframe: Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose
• Results posted on: 2020-08-26

Participant Flow

8 subjects not randomized.

Participant milestones

Measure	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.	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.
Overall Study STARTED	52	48
Overall Study COMPLETED	51	48
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Measure	TRI102 n=51 Participants Active, amphetamine extended-release oral suspension TRI102: formulation containing active moiety (amphetamine)	Placebo n=48 Participants Placebo Placebo: formulation without active moiety	Total n=99 Participants Total of all reporting groups
Age, Continuous	9.2 Years STANDARD_DEVIATION 1.95 • n=5 Participants	9.6 Years STANDARD_DEVIATION 1.76 • n=7 Participants	9.4 Years STANDARD_DEVIATION 1.86 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	32 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	27 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
ADHD Type Predominantly inattentive	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
ADHD Type Predominantly impulsive	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
ADHD Type Combined	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose

Population: Intention to treat population

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.

Outcome measures

Measure	TRI102 n=51 Participants 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.	Placebo n=48 Participants 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.
SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale)	-9.1 score on a scale Standard Deviation 7.51	5.6 score on a scale Standard Deviation 7.85

SECONDARY outcome

Timeframe: Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose.

Population: Intention to treat

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.

Outcome measures

Measure	TRI102 n=51 Participants 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.	Placebo n=48 Participants 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.
PERMP (Permanent Product Measure of Performance).	25.3 PERMP questions answered correctly Standard Error 4.21	-13.6 PERMP questions answered correctly Standard Error 4.39

Adverse Events

TRI102

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TRI102 n=52 participants at risk Active, amphetamine extended-release oral suspension TRI102: formulation containing active moiety (amphetamine)	Placebo n=48 participants at risk Placebo Placebo: formulation without active moiety
Gastrointestinal disorders Abdominal pain, upper	3.8% 2/52 • Number of events 2 • Screening through Follow up (9 weeks) AEs were recorded at each study visit for a total of 9 weeks.	2.1% 1/48 • Number of events 1 • Screening through Follow up (9 weeks) AEs were recorded at each study visit for a total of 9 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.8% 2/52 • Number of events 2 • Screening through Follow up (9 weeks) AEs were recorded at each study visit for a total of 9 weeks.	0.00% 0/48 • Screening through Follow up (9 weeks) AEs were recorded at each study visit for a total of 9 weeks.
Respiratory, thoracic and mediastinal disorders Rhinitis, allergic	3.8% 2/52 • Number of events 2 • Screening through Follow up (9 weeks) AEs were recorded at each study visit for a total of 9 weeks.	0.00% 0/48 • Screening through Follow up (9 weeks) AEs were recorded at each study visit for a total of 9 weeks.

Additional Information

Antonio Pardo MD

Tris Pharma, Inc.

Phone: 732-823-4755

Email: apardo@trispharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place