Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01835548 | NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD) | PHASE3 | COMPLETED | 87 | — | — | Jul 1, 2013 | Jul 1, 2014 | Jan 17, 2018 | 4 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| NT0102 | DRUG | NT0102 (methylphenidate polistirex \[MPP\] extended release \[XR\] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride. |
| Placebo | DRUG | Matching ODT placebo was given once daily. |
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