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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835548
• Other study ID #: NT0102.1004
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2013
• Last updated: December 18, 2017
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2017
• Source: Neos Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Disease
• Hyperkinesis

Intervention

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
Matching ODT placebo was given once daily.

Locations

Country	Name	City	State
United States	Florida Clinical Research Center	Bradenton	Florida
United States	Duke University	Durham	North Carolina
United States	Center for Psychiatry and Behavioral Medicine	Las Vegas	Nevada
United States	Florida Clinical Research Center	Maitland	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Neos Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)