At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 163 enrolled
Drug / intervention
HLD200 methylphenidate hydrochloride (MPH) Capsules +1 moredrug
Likely dose
HLD200 methylphenidate hydrochloride (MPH) Capsules 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ph 3 Multicenter DBRCT Parallel Group Study to Evaluate Safety & Efficacy of Evening-dosed HLD200, a Novel Delayed & Extended Release Formulation (DELEXIS) of MPH HCl, on Post-waking, Early Morning Function in Children Aged 6-12 With ADHD
Ironshore Pharmaceuticals and Development, Inc·interventional·Posted Aug 11, 2015·Updated Jul 23, 2021
In Brief
A Phase 3 clinical trial evaluating HLD200 methylphenidate hydrochloride (MPH) Capsules and Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 163 participants across 21 sites.
Detailed Summary
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a naturalistic setting. Following a screening/washout period (Visit 1), subjects will randomized to double-blind placebo or HLD200 for a period of 3 weeks (Visits 2-5) before assessing clinical study endpoints at last study visit.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedAug 2015
Primary CompletionApr 2016
Study CompletionMay 2016
TodayJul 2026
First PostedAug 11, 2015
Enrollment StartAug 1, 2015
Primary CompletionApr 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.9 years ago
Interventions
HLD200 methylphenidate hydrochloride (MPH) Capsulesdrug
HLD200 Doses: 40, 60 or 80 mg
Placebodrug