A Randomized, Multicenter, Double-Blind, Placebo Controlled, Parallel Group Study of NT0102 in Children (Ages 6 12 Years) With Attention-Deficit Hyperactivity Disorder
Overview
- Phase
- Phase 3
- Intervention
- NT0102
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Sponsor
- Neos Therapeutics, Inc
- Enrollment
- 87
- Locations
- 3
- Primary Endpoint
- Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: NT0102
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score
Time Frame: Visit 8 (Day 42)
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.
Secondary Outcomes
- Number of Participants With Adverse Events(Visit 9 (Day 43))
- 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 Permanent Product Measure of Performance - Correct (PERMP-C) Score(Visit 8 (Day 42))
- Onset 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-Deportment Scores(Visit 8 (Day 42))
- The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score(Visit 8 (Day 42))