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A Post-Hoc Analysis of Emotional Lability With Delayed-Release/Extended-Release Methylphenidate in Children Aged 6 to 12 Years of Age Participating in Two Phase 3 Clinical Trials.
- Source :
-
Journal of attention disorders [J Atten Disord] 2024 Jun; Vol. 28 (8), pp. 1186-1197. Date of Electronic Publication: 2024 Apr 10. - Publication Year :
- 2024
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Abstract
- Objective: DR/ER-MPH (formerly HLD200) is an evening-dosed delayed-release and extended-release methylphenidate approved for the treatment of ADHD in patients ≥6 years. Post hoc analyses of two pivotal Phase 3 trials: HLD200-107 (NCT02493777) and HLD200-108 (NCT02520388) evaluated emotional lability (EL) with DR/ER-MPH treatment.<br />Methods: Differences in Conners Global Index-Parent (CGI-P) EL subscale scores and age- and gender-adjusted T -scores over an open-label titration phase (HLD200-107) and between treatment and placebo groups at endpoint (HLD200-108) were evaluated.<br />Results: In HLD200-107 ( N = 117) mean CGI-P EL subscale scores improved from 5.3 to 1.3 ( p < .0001) after 6 weeks; in HLD200-108 significant improvements were observed in the treatment group ( n = 81) versus placebo ( n = 80; 3.11 vs. 4.08; p = .0053). T -scores showed an improvement with DR/ER-MPH treatment in both trials. Few emotional adverse events (AEs) were reported.<br />Conclusion: DR/ER-MPH treatment resulted in statistically significant improvements in EL to the level of non-ADHD peers as contextualized by T -scores.<br />Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: VKA: Advisory Board/Consultant—Ironshore, Neos, Rho, Shire; Speakers Bureau—Ironshore Pharmaceuticals Inc., Lundbeck/Takeda. FAL: Consultant, Speaker, and/or Research Support—Cingulate, Corium, Eli Lilly, GSK, Ironshore, Neos, Novartis, Noven, Pfizer, Rhodes, Shionogi, Shire, Sunovion, Supernus, Tris. ACC: Research Support—Acadia, Akili Interactive Labs, Allergan, Arbor Pharmaceuticals, LLC, Axial, Cingulate, Corium, Emalex, Forest Laboratories, Ironshore, KemPharm, Inc., Lumos, Neos Therapeutics, Neurocentria, Otsuka America Pharmaceutical, Inc., Purdue Pharma, Rhodes Pharmaceuticals, Servier, Shire, Sunovion Pharmaceuticals, Inc., Supernus Pharmaceuticals, Inc., Takeda Pharmaceutical Company Ltd., Tris Pharma, Advisory Board—Adlon, Akili Interactive Labs, Arbor Pharmaceuticals, LLC, Cingulate Therapeutics, Otsuka America Pharmaceutical, Inc., Pfizer, Purdue Pharma, Shire, Sunovion Pharmaceuticals, Inc., Supernus Pharmaceuticals, Inc., Takeda Pharmaceutical Company Ltd., Tris Pharma; Consultant—Arbor Pharmaceuticals, LLC, Aytu, Attentive Therapeutics, Corium, Ironshore, KemPharm, Inc., Lumos, Neos Therapeutics, Neurocentria, ., Purdue Pharma, Sunovion Pharmaceuticals, Inc., Supernus Pharmaceuticals, Inc., Tris Pharma; Speakers Bureau—Ironshore, Takeda Pharmaceutical Company Ltd., Tris Pharma; Writing Support—Arbor Pharmaceuticals, LLC, Ironshore, Neos Therapeutics, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire, Sunovion Pharmaceuticals, Inc., Takeda Pharmaceutical Company Ltd., Tris Pharma. MDP, CLU, LC, and BI: Employees—Ironshore. FRS: Employee—Ironshore; Advisory Board/Board of Directors—P2D Bioscience.
- Subjects :
- Humans
Child
Male
Female
Double-Blind Method
Treatment Outcome
Affective Symptoms drug therapy
Methylphenidate administration & dosage
Methylphenidate pharmacology
Delayed-Action Preparations
Central Nervous System Stimulants administration & dosage
Central Nervous System Stimulants pharmacology
Attention Deficit Disorder with Hyperactivity drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1557-1246
- Volume :
- 28
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Journal of attention disorders
- Publication Type :
- Academic Journal
- Accession number :
- 38600754
- Full Text :
- https://doi.org/10.1177/10870547241243155