Phase 3
Completed N=86
NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT01654250 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points — 19.1; 12.1 units on a scale — p=<0.001
Summary
The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points |
19.1; 12.1 | <0.001 sig |
| SECONDARY Onset and Duration of Clinical Effect |
18.3; 10.7; 20.3; 8.0; 19.8; 8.1 | <0.001 sig |
| SECONDARY Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose |
2.9; 1.6; 4.6; 2.1; 3.4; 1.1 | 0.007 sig |
| SECONDARY Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose |
105.4; 128.8; 102.8; 123.9; 106.6; 140.9 | 0.024 sig |
Eligibility Criteria
Inclusion Criteria
- Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition
Exclusion Criteria
- Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
Data sourced from ClinicalTrials.gov (NCT01654250). 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.