Phase 3
Completed N=87
NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT01835548 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score — 24.3; 17.3 score on a scale — p=<0.0001
◆ Published Evidence
Established
42citations · ~5 / year
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.
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.
Linked Publications (2)
-
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.
-
Open-Label Dose Optimization of Methylphenidate Extended-Release Orally Disintegrating Tablet in a Laboratory Classroom Study of Children with Attention-Deficit/Hyperactivity Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score |
24.3; 17.3 | <0.0001 sig |
| SECONDARY Onset of Effect |
1 | — |
| SECONDARY Duration of Effect |
12 | — |
| SECONDARY The Average of the SKAMP-Attention Scores |
12.2; 9.4 | — |
| SECONDARY The Average of the SKAMP-Deportment Scores |
12.5; 7.9 | — |
| SECONDARY The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score |
82.0; 107.5 | — |
| SECONDARY The Average of the Permanent Product Measure of Performance - Correct (PERMP-C) Score |
78.6; 104.1 | — |
| SECONDARY Number of Participants With Adverse Events |
70; 10; 11 | — |
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
Data sourced from ClinicalTrials.gov (NCT01835548) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.