HLD200 methylphenidate hydrochloride (MPH) Capsules

DRUG2 trials

Sponsors

Ironshore Pharmaceuticals and Development, Inc

Conditions

Attention Deficit Hyperactivity Disorder

Phase 3

A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting

CompletedNCT02493777

Ironshore Pharmaceuticals and Development, IncAttention Deficit Hyperactivity Disorder

Start: 2015-07-31End: 2016-03-31Updated: 2021-07-23

A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting

CompletedNCT02520388

Ironshore Pharmaceuticals and Development, IncAttention Deficit Hyperactivity Disorder

Start: 2015-08-31End: 2016-05-31Updated: 2021-07-23

Related Papers

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

Journal of Attention Disorders2024-04-10

Adverse Events During Dosing of Delayed-release/Extended-release Methylphenidate: Learnings From the Open-label Phase of a Registration Trial and a Real-world Postmarketing Surveillance Program

Clinical Therapeutics2023-09-271 citations

Symptomatic and Functional Response and Remission From the Open-Label Treatment-Optimization Phase of a Study With DR/ER-MPH in Children With ADHD

The Journal of Clinical Psychiatry2021-06-227 citations

Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate

Journal of Attention Disorders2021-06-0412 citations

Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder

Journal of Child and Adolescent Psychopharmacology2021-04-016 citations

A Post Hoc Comparison of Prior ADHD Medication Dose and Optimized Delayed-release and Extended-release Methylphenidate Dose in a Pivotal Phase III Trial

Clinical Therapeutics2020-11-066 citations

Improvement in Functional Impairment During the Early Morning and Late Afternoon/Evening Bookends of the Day: Data from Two Phase 3 Trials of Evening-Dosed Delayed-Release and Extended-Release Methylphenidate in Children with ADHD

PEDIATRICS2020-07-012 citations

Improvement in Functional Impairment During the Early Morning and Late Afternoon/Evening Bookends of the Day: Data from Two Phase 3 Trials of Evening-Dosed Delayed-Release and Extended-Release Methylphenidate in Children with ADHD

2020-07-01

129 Effect of DR/ER-MPH on Caregiver-Reported ADHD Symptom Improvement in Children With ADHD and Caregiver Strain: Results From a Phase 3 Trial

CNS Spectrums2018-02-012 citations

128 Effect of DR/ER-MPH on Early Morning and Late Afternoon/Evening Functioning in Children With ADHD: Analysis of PREMB-R Items From a Phase 3 Trial

CNS Spectrums2018-02-012 citations

130 Consistent Efficacy of DR/ER-MPH on Early Morning Functioning in Children With ADHD: Analysis of BSFQ Item Ratings From a Pivotal Phase 3 Trial

CNS Spectrums2018-02-01