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Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT01835548

NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase 3 study testing NT0102 in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Neos Therapeutics, Inc at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory classroom study. Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
NT0102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
4 sitesUnited States
Study dates
Jul 2013to Jul 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

  • Currently being treated for ADHD

Who cannot join

  • Other psychiatric diagnoses
  • Significant cognitive impairment
  • Chronic medical illnesses
  • Structural cardiac defects
  • Significant abnormal lab tests
  • Taking disallowed medications
  • Positive drug test

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Florida Clinical Research Center

    Bradenton, Florida, 34208

  • Duke University

    Durham, North Carolina, 27705

  • Center for Psychiatry and Behavioral Medicine

    Las Vegas, Nevada, 89128

  • Florida Clinical Research Center

    Maitland, Florida, 32751

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo Controlled, Parallel Group Study of NT0102 in Children (Ages 6 12 Years) With Attention-Deficit Hyperactivity Disorder

This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory classroom study.

Being tested
NT0102, 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.

  • NT0102Drug

    NT0102 (methylphenidate polistirex [MPP] extended release [XR] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride.

  • PlaceboDrug

    Matching ODT placebo was given once daily.

Study groups in NCT01835548
Study groupRoleWhat they receive
NT0102ExperimentalAfter the screening/washout period, all participants will receive study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug will be selected, and participants will stay on that dose for 1 week (dose stabilization period). At the end of this period, participants will be randomized to a treatment. Participants in this arm will be given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period.
Receives: Drug: NT0102
PlaceboPlacebo comparatorAfter the screening/washout period, all participants will receive study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug will be selected, and participants will stay on that dose for 1 week (dose stabilization period). At the end of this period, participants will be randomized to a treatment. Participants in this arm will be given placebo as matching ODT once daily for one week during the double-blind treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score

    The primary efficacy endpoint was derived from the SKAMP-Combined score calculated as the total score of all 13 items of the SKAMP-Combined score. The SKAMP-Combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible score of 0 to 78. A lower score indicates less symptomatology (i.e., is better). The SKAMP was a rating scale that specifically measures the classroom manifestations of ADHD. The SKAMP ratings were completed for all subjects at baseline (pre-dose) and at 1, 3, 5, 7, 10, 12, and 13 hours post-dose on the classroom testing day (Visit 8). The primary analysis time point for the primary efficacy endpoint was the average of all post-dose SKAMP scores during the 13-hour period.

    Measured: Visit 8 (Day 42)

Secondary outcomes (7)

  1. Onset of Effect

    Onset of effect was defined as the first time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8.

    Measured: Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h

  2. Duration of Effect

    Duration of effect was defined as the last time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms, and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8.

    Measured: Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h

  3. The Average of the SKAMP-Attention Scores

    The SKAMP Rating Scale was comprised of 2 behavioral subscales, including the "Attention" subscale (4 items). The SKAMP-Attention subscore evaluates concentration in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behavior. Ratings were based on the frequency and quality of behaviors.

    Measured: Visit 8 (Day 42)

  4. The Average of the SKAMP-Deportment Scores

    The SKAMP Rating Scale is comprised of 2 behavioural subscales, including the "Deportment" subscale (4 items). The SKAMP-Deportment subscore evaluates behaviour in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behaviour. Ratings were based on the frequency and quality of behaviours.

    Measured: Visit 8 (Day 42)

  5. The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score

    The PERMP consisted of 400 math problems and was graded as number of problems "Attempted" (PERMP-A) and number of problems "Correct." (PERMP-C). It was an objective measure of performance during the classroom testing day.

    Measured: Visit 8 (Day 42)

  6. The Average of the Permanent Product Measure of Performance - Correct (PERMP-C) Score

    The PERMP consisted of 400 math problems and was graded as number of problems "Attempted" (PERMP-A) and number of problems "Correct." (PERMP-C). It was an objective measure of performance during the classroom testing day.

    Measured: Visit 8 (Day 42)

  7. Number of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Visit 9 (Day 43)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

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
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01835548
Sponsor's protocol ID
NT0102.1004
Status last verified
Dec 2017
First submitted
8 Apr 2013
Last updated
17 Jan 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Open-Label Dose Optimization of Methylphenidate Extended-Release Orally Disintegrating Tablet in a Laboratory Classroom Study of Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):342-349. doi: 10.1089/cap.2020.0142. Epub 2021 Jun 2.

    PubMed 34081560

  • Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder in the Laboratory Classroom Setting. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):66-74. doi: 10.1089/cap.2016.0002. Epub 2016 May 16.

    PubMed 27183299

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NT0102 in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Neos Therapeutics, Inc at 4 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 7 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 17 Jan 2018). 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?

Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score (time frame: Visit 8 (Day 42)). 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 NCT01835548, which also lists 2 linked publications.

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 17 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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