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

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ClinicalTrials.gov Identifier: NCT02083783
Recruitment Status : Completed
First Posted : March 11, 2014
Results First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Tris Pharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: TRI102 Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHA): A Laboratory Classroom Study
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: TRI102
Active, amphetamine extended-release oral suspension
Drug: TRI102
formulation containing active moiety (amphetamine)
Other Name: amphetamine extended-release oral suspension

Placebo Comparator: Placebo
Placebo
Other: Placebo
formulation without active moiety




Primary Outcome Measures :
  1. SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale) [ Time Frame: 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 Outcome Measures :
  1. PERMP (Permanent Product Measure of Performance). [ Time Frame: 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.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083783


Locations
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United States, California
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States, 92660
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Texas
Bayou City Research
Houston, Texas, United States, 77007
Westex Clinical Investigation
Lubbock, Texas, United States, 79423
Sponsors and Collaborators
Tris Pharma, Inc.
Investigators
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Principal Investigator: Sharon Wigal, PhD Newport Beach Clinical Research Associates, Inc.
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Responsible Party: Tris Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02083783    
Other Study ID Numbers: TRI102-ADD-001
First Posted: March 11, 2014    Key Record Dates
Results First Posted: August 26, 2020
Last Update Posted: August 26, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors