At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 125 enrolled
Drug / intervention
HLD200 methylphenidate hydrochloride (MPH) Capsules +1 moredrug
Likely dose
HLD200 methylphenidate hydrochloride (MPH) Capsules 100 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 OL Treatment-optimized RDBPC Forced-withdrawal, Parallel Grp Study to Evaluate Safety & Efficacy of Evening Dosed HLD200, a Novel DR/ER Formulation (DELEXIS) of MPH HCl in Children Aged 6-12 With ADHD in Classroom Setting
Ironshore Pharmaceuticals and Development, Inc·interventional·Posted Jul 10, 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 125 participants across 7 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 laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedJul 2015
Primary CompletionFeb 2016
Study CompletionMar 2016
TodayJul 2026
First PostedJul 10, 2015
Enrollment StartJul 1, 2015
Primary CompletionFeb 1, 2016
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.0 years ago
Interventions
HLD200 methylphenidate hydrochloride (MPH) Capsulesdrug
HLD200 doses: 20, 40, 60, 80 or 100 mg
Placebodrug