Trial
NCT06431256
Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD
Phase IIITERMINATEDREGULATORYConfidence: HIGH
Sponsor
Ironshore Pharmaceuticals and Development, Inc
Collaborators
Collegium Pharmaceutical, Inc.
Condition
Attention Deficit Hyperactivity Disorder
Intervention
HLD200 methylphenidate hydrochloride capsules
Why stopped
FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.
Provenance
Dataset: 2026-07-02 • Source: ClinicalTrials.gov API v2 • Last update: 2025-11-06