Adults 6 to 12, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post DosePrimary· Change in SKAMP-C score from baseline to 30 minutes postdose.
Change in SKAMP-C (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined) score from pre-dose, by treatment. The SKAMP-C is a rating scale that assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom. The SKAMP-C is a 13-item, 7-score rating system (0=normal to 7=maximal impairment). The higher the score, the worse the impairment. A decrease from baseline in the combined (all 13 items) score indicates improvement. The SKAMP-C is used to assess the time course of tr
Group
Value
95% CI
Active Treatment
-6.1
± 2.29
Placebo Treatment
2.5
± 2.29
Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly)Secondary· 30 minutes postdose and 3 hours postdose
Change from pre-dose in PERMP-C scores (Permanent Product Measure of Performance; defined as the number of problems attempted and number of problems solved correctly) at 30 minutes post-dose and at 3 hours post-dose. The PERMP-C is designed to assess compliance and academic productivity in school children. It is a 10-minute timed test in which the number of problems attempted and correct are assessed prior to and after an intervention. Scoring is based on problems attempted and correct. An increase in numerical score is indicative of improvement.
Change from predose in PERMP-C at 30 minutes
Group
Value
95% CI
Active Treatment
14.4
± 7.25
Placebo Treatment
-4.7
± 7.25
Change from predose in PERMP-C at 3 hours
Group
Value
95% CI
Active Treatment
52.4
± 9.43
Placebo Treatment
-7.9
± 9.43
Adverse events — posted to ClinicalTrials.gov
Time frame: The duration of the study (5 weeks from screening to final follow-up assessment).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tris Pharma, Inc.
Last refreshed: 22 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03088267.