NCT02083783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

August 26, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

March 7, 2014

Results QC Date

May 15, 2019

Last Update Submit

August 24, 2020

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • PERMP (Permanent Product Measure of Performance).

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

Study Arms (2)

TRI102

EXPERIMENTAL

Active, amphetamine extended-release oral suspension

Drug: TRI102

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

TRI102DRUG

formulation containing active moiety (amphetamine)

Also known as: amphetamine extended-release oral suspension
TRI102
PlaceboOTHER

formulation without active moiety

Placebo

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

You may not qualify if:

  • Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Newport Beach Clinical Research Associates, Inc.

Newport Beach, California, 92660, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Bayou City Research

Houston, Texas, 77007, United States

Location

Westex Clinical Investigation

Lubbock, Texas, 79423, United States

Location

Related Publications (1)

  • 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.

    PMID: 36730749DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

TRI102 protein, Gibberella zeae

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Antonio Pardo MD
Organization
Tris Pharma, Inc.
apardo@trispharma.com
732-823-4755

Study Officials

  • Sharon Wigal, PhD

    Newport Beach Clinical Research Associates, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

August 26, 2020

Results First Posted

August 26, 2020

Record last verified: 2020-08

Locations

US(5)