Attention Deficit Disorder With HyperactivityPhase 3NCT02083783
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study testing TRI102 in people with Attention Deficit Disorder With Hyperactivity, run by Tris Pharma, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- TRI102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition
Who cannot join
- Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Duke University Medical Center
Durham, North Carolina, 27705
Bayou City Research
Houston, Texas, 77007
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Westex Clinical Investigation
Lubbock, Texas, 79423
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92660
About this study
Official title: TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHA): A Laboratory Classroom Study
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.
Read the 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.
- Being tested
- TRI102, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRI102Drug
Also called amphetamine extended-release oral suspension
formulation containing active moiety (amphetamine)
PlaceboOther
formulation without active moiety
| Study group | Role | What they receive |
|---|---|---|
| TRI102 | Experimental | Active, amphetamine extended-release oral suspension Receives: Drug: TRI102 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose
Secondary outcomes (1)
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.
Measured: Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Wigal, PhD, Principal investigator, Newport Beach Clinical Research Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083783
- Sponsor's protocol ID
- TRI102-ADD-001
- Status last verified
- Aug 2020
- First submitted
- 7 Mar 2014
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 36730749
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHA): A Laboratory Classroom Study
- ClinicalTrials.gov ID
- NCT02083783
- Acronym / sponsor ID
- TRI102-ADD-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRI102 | Experimental | Drug: TRI102Active, amphetamine extended-release oral suspension |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition
Key exclusion criteria (1 listed)
- Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRI102Also: amphetamine extended-release oral suspensionformulation containing active moiety (amphetamine) | Drug | TRI102 |
| Placeboformulation without active moiety | Other | Placebo |
Primary outcome
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.
1 secondary outcome
PERMP (Permanent Product Measure of Performance).
Time frame: Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36730749Faraone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Wigal, PhD principal investigator
Newport Beach Clinical Research Associates, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TRI102 in people with Attention Deficit Disorder With Hyperactivity, run by Tris Pharma, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.