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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Drug: NT0102; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34208
      • Florida Clinical Research Center
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center For Psychiatry And Behavioral Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Currently being treated for ADHD

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NT0102; After 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.	Drug: NT0102; NT0102 (methylphenidate polistirex [MPP] extended release [XR] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride.
Placebo Comparator: Placebo; After 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.	Drug: Placebo; Matching ODT placebo was given once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 8 (Day 42)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h
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.	Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h
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.	Visit 8 (Day 42)
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.	Visit 8 (Day 42)
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.	Visit 8 (Day 42)
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.	Visit 8 (Day 42)
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.	Visit 9 (Day 43)

Collaborators and Investigators

• Sponsor: Neos Therapeutics, Inc
• Investigators: Study Director: Carolyn Sikes, PhD, Neos Tx

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 19, 2013

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: NT0102.1004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No