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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00904670 | Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) | PHASE3 | COMPLETED | 45 | — | — | Apr 1, 2009 | Aug 1, 2009 | Jun 26, 2014 | 2 | United States |
The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite 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 combined score of 0 to 78; where higher score signified worst impairment.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Comparator | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Quillivant Oral Suspension XR | DRUG | Oral Suspension 25mg/5mL; 20-60 mg/day |
| Placebo | DRUG | Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day |
Inclusion Criteria: * Male or female from 6 to 12 years of age at the time of screening, inclusive. * Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia ...