PMID- 27183299 OWN - NLM STAT- MEDLINE DCOM- 20180111 LR - 20181113 IS - 1557-8992 (Electronic) IS - 1044-5463 (Print) IS - 1044-5463 (Linking) VI - 27 IP - 1 DP - 2017 Feb TI - Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder in the Laboratory Classroom Setting. PG - 66-74 LID - 10.1089/cap.2016.0002 [doi] AB - OBJECTIVE: Methylphenidate extended-release orally disintegrating tablets (MPH XR-ODTs) represent a new technology for MPH delivery. ODTs disintegrate in the mouth without water and provide a pharmacokinetic profile that is consistent with once-daily dosing. This study sought to determine the efficacy, safety, and tolerability of this novel MPH XR-ODT formulation in school-age children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting. METHODS: Children aged 6-12 years with ADHD (n = 87) were enrolled in this randomized, multicenter, double-blind, placebo-controlled, parallel, laboratory classroom study. The MPH XR-ODT dose was titrated to an optimized dose during a 4-week open-label period and maintained on that dose for 1 week. Participants (n = 85) were then randomized to receive their optimized dose of MPH XR-ODT or placebo once daily for 1 week (double blind), culminating in a laboratory classroom testing day. Efficacy was evaluated using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Attention, Deportment, and Combined scores along with Permanent Product Measure of Performance (PERMP; Attempted and Correct) assessments. Onset and duration of drug action were also evaluated as key secondary endpoints. Safety assessments included adverse events (AEs), physical examinations, electrocardiograms (ECGs), and the Columbia Suicide Severity Rating Scale (C-SSRS). RESULTS: The average SKAMP-Combined score on the classroom study day was significantly better for the MPH XR-ODT group (n = 43) than for the placebo group (n = 39; p < 0.0001). The effect was evident at 1 hour and lasted through 12 hours postdose. The average SKAMP-Attention, SKAMP-Deportment, PERMP-A, and PERMP-C scores were indicative of significantly greater ADHD symptom control for the MPH XR-ODT group. The most common AEs reported were decreased appetite, upper abdominal pain, headache, insomnia, upper respiratory tract infection, affect lability, irritability, cough, and vomiting. CONCLUSIONS: MPH XR-ODT was effective and well tolerated for the treatment of children with ADHD in a laboratory classroom setting. Clinical Trial Registry: NCT01835548 ( ClinicalTrials.gov ). FAU - Childress, Ann C AU - Childress AC AD - 1 Center for Psychiatry and Behavioral Medicine , Las Vegas, Nevada. FAU - Kollins, Scott H AU - Kollins SH AD - 2 Department of Psychiatry and Behavioral Science, Duke University , Durham, North Carolina. FAU - Cutler, Andrew J AU - Cutler AJ AD - 3 Florida Clinical Research Center , Bradenton, Florida. FAU - Marraffino, Andrea AU - Marraffino A AD - 4 Florida Clinical Research Center , Orlando, Florida. FAU - Sikes, Carolyn R AU - Sikes CR AD - 5 Neos Therapeutics, Inc. , Grand Prairie, Texas. LA - eng SI - ClinicalTrials.gov/NCT01835548 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20160516 PL - United States TA - J Child Adolesc Psychopharmacol JT - Journal of child and adolescent psychopharmacology JID - 9105358 RN - 0 (Central Nervous System Stimulants) RN - 0 (Delayed-Action Preparations) RN - 0 (Tablets) RN - 207ZZ9QZ49 (Methylphenidate) SB - IM MH - Administration, Oral MH - Attention Deficit Disorder with Hyperactivity/*drug therapy MH - Central Nervous System Stimulants/*administration & dosage/adverse effects MH - Child MH - Delayed-Action Preparations MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - *Drug Delivery Systems MH - Female MH - Humans MH - Male MH - Methylphenidate/*administration & dosage/adverse effects MH - Tablets MH - Treatment Outcome PMC - PMC5326982 OTO - NOTNLM OT - ADHD OT - MPH XR-ODT OT - classroom study OT - efficacy OT - safety COIS- Dr. A.C.C. has received research support from, consulted with, acted as an invited speaker for, and/or served on advisory boards for Alcobra Pharma, Arbor Pharmaceuticals, Forest Research Institute, Ironshore Pharmaceuticals, Lilly USA, Lundbeck, Neos Therapeutics, Neurovance, NextWave Pharmaceuticals, Noven Pharmaceuticals, Otsuka Pharmaceutical, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire Pharmaceuticals, Sunovion Pharmaceuticals, Theravance Biopharma, and Tris Pharma. Dr. S.H.K. has received research support from and/or consulted with Akili Interactive; Alcobra Pharma; Arbor Pharmaceuticals; Atentiv; National Institutes of Health (NIDA, NIEHS, NICHD); Neos Therapeutics, Neurovance; Purdue Pharma; Rhodes Pharmaceuticals; Shire Pharmaceuticals; Sunovion Pharmaceuticals; Tris Pharma; and US Environmental Protection Agency. Dr. A.J.C. has received research support from, consulted with, and/or acted as an invited speaker for Akili Interactive; Arbor Pharmaceuticals; AstraZeneca; Janssen Pharmaceuticals; Lilly; Lundbeck; Neos Therapeutics; Neurovance; Novartis Pharmaceuticals; Noven Pharmaceuticals; Otsuka Pharmaceutical; Pfizer; Purdue Pharma; Rhodes Pharmaceuticals; Shire Pharmaceuticals; Sunovion Pharmaceuticals; Supernus Pharmaceuticals; Takeda Pharmaceuticals; and Teva Pharmaceutical. Dr. C.R.S. is an employee of Neos Therapeutics and has stock options. Dr. Sikes has stock in Pfizer. Dr. A.M. has no financial relationships to disclose. EDAT- 2016/05/18 06:00 MHDA- 2018/01/13 06:00 PMCR- 2017/02/01 CRDT- 2016/05/17 06:00 PHST- 2016/05/18 06:00 [pubmed] PHST- 2018/01/13 06:00 [medline] PHST- 2016/05/17 06:00 [entrez] PHST- 2017/02/01 00:00 [pmc-release] AID - 10.1089/cap.2016.0002 [pii] AID - 10.1089/cap.2016.0002 [doi] PST - ppublish SO - J Child Adolesc Psychopharmacol. 2017 Feb;27(1):66-74. doi: 10.1089/cap.2016.0002. Epub 2016 May 16.