Clinical trial NCT01835548: NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Neos Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 87
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score
timeFrame: Visit 8 (Day 42)
Secondary outcomes:
measure: Onset of Effect
timeFrame: Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h
measure: Duration of Effect
timeFrame: Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h
measure: The Average of the SKAMP-Attention Scores
timeFrame: Visit 8 (Day 42)
measure: The Average of the SKAMP-Deportment Scores
timeFrame: Visit 8 (Day 42)
measure: The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score
timeFrame: Visit 8 (Day 42)
measure: The Average of the Permanent Product Measure of Performance - Correct (PERMP-C) Score
timeFrame: Visit 8 (Day 42)
measure: Number of Participants With Adverse Events
timeFrame: Visit 9 (Day 43)
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine
state: Nevada
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Neos Tx
name: Carolyn Sikes, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.