Back to resultsTRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TRI102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
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
Sites / Locations
- Newport Beach Clinical Research Associates, Inc.
- Center for Psychiatry and Behavioral Medicine, Inc.
- Duke University Medical Center
- Bayou City Research
- Westex Clinical Investigation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TRI102
Placebo
Arm Description
Active, amphetamine extended-release oral suspension
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02083783
Brief Title
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHA): A Laboratory Classroom Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tris Pharma, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRI102
Arm Type
Experimental
Arm Description
Active, amphetamine extended-release oral suspension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
TRI102
Other Intervention Name(s)
amphetamine extended-release oral suspension
Intervention Description
formulation containing active moiety (amphetamine)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
formulation without active moiety
Primary Outcome Measure Information:
Title
SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale)
Description
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
Secondary Outcome Measure Information:
Title
PERMP (Permanent Product Measure of Performance).
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Wigal, PhD
Organizational Affiliation
Newport Beach Clinical Research Associates, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Bayou City Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Westex Clinical Investigation
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
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