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

NCT01835548 | Completed Phase 3 Results FDA Drug

• 1 other identifier: NT0102.1004
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (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.

  Visit 8 (Day 42)

Secondary Outcomes (7)

• Onset of Effect

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

• Duration of Effect

  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

  Visit 8 (Day 42)

• The Average of the SKAMP-Deportment Scores

  Visit 8 (Day 42)

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

  Visit 8 (Day 42)

Study Arms (2)

NT0102

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

NT0102 DRUG

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

NT0102

Placebo DRUG

Matching ODT placebo was given once daily.

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Currently being treated for ADHD

You may not qualify if:

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

Sponsors & Collaborators

• Neos Therapeutics, Inc: lead

Study Sites (4)

Florida Clinical Research Center

Bradenton, Florida, 34208, United States

Location

Florida Clinical Research Center

Maitland, Florida, 32751, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• 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.

  PMID: 34081560 DERIVED

• 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.

  PMID: 27183299 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Carolyn Sikes, PhD
• Organization: Neos Tx

csikes@neostx.com

972-408-1300

Study Officials

• Carolyn Sikes, PhD

  Neos Tx

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 19, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 17, 2018
• Results First Posted: January 17, 2018

Record last verified: 2017-12

Locations

US (4)