A Randomized, Double-Blind, Placebo-Controlled Study of HLD200, a Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder: An Evaluation of Safety and Efficacy Throughout the Day and Across Settings
| Autor: | Floyd R. Sallee, Mary Ann McDonnell, Andrea Marraffino, Norberto J. DeSousa, Bev Incledon, Sharon B. Wigal, Matthew Brams, John M. Turnbow, Ann C. Childress, Andrew J. Cutler |
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| Rok vydání: | 2020 |
| Předmět: |
DR/ER-MPH
safety Male Placebo-controlled study methylphenidate Upon Awakening attention-deficit/hyperactivity disorder Double blind 03 medical and health sciences 0302 clinical medicine Double-Blind Method mental disorders medicine Humans Attention deficit hyperactivity disorder Pharmacology (medical) Child Psychiatric Status Rating Scales business.industry Methylphenidate Therapeutic effect duration Original Articles Delayed release (linguistics) medicine.disease 030227 psychiatry Psychiatry and Mental health functional impairment Attention Deficit Disorder with Hyperactivity Delayed-Action Preparations Anesthesia Pediatrics Perinatology and Child Health Central Nervous System Stimulants Female Extended release business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Journal of Child and Adolescent Psychopharmacology |
| ISSN: | 1557-8992 1044-5463 |
| DOI: | 10.1089/cap.2019.0070 |
| Popis: | Objectives: HLD200, a once-daily, evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH), was designed to provide therapeutic effect beginning upon awakening and lasting into the evening. This pivotal, randomized, double-blind, multicenter, placebo-controlled, phase 3 trial assessed improvements in functional impairment across the day using multiple validated measures tailored for different settings and time of day in children (6–12 years) with attention-deficit/hyperactivity disorder (ADHD). Methods: Following a 6-week, open-label titration of DR/ER-MPH to an optimal dose (20, 40, 60, 80, or 100 mg/day) and dosing time (8:00 PM ±1.5 hours), participants were randomized to treatment-optimized DR/ER-MPH or placebo for 1 week. The primary endpoint was the model-adjusted average of postdose Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale combined scores (SKAMP CS) over a 12-hour laboratory classroom day (8:00 AM to 8:00 PM). The key secondary endpoint was the Parent Rating of Evening and Morning Behavior-Revised, Morning (PREMB-R AM) subscale. Secondary/exploratory measures included the PREMB-R Evening (PREMB-R PM) subscale and Permanent Product Measure of Performance (Attempted [PERMP-A] and Correct [PERMP-C]). Safety endpoints included treatment-emergent adverse events (TEAEs). Results: After the treatment-optimization phase, the mean optimized dose was 66.2 mg and the most common prescribed dosing time was 8:00 PM. Double-blind DR/ER-MPH treatment significantly improved functional impairment versus placebo in the early morning (PREMB-R AM: p |
| Databáze: | OpenAIRE |
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