Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years with ADHD

PHASE3RecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

September 13, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Attention Deficit Hyperactivity Disorder
Interventions
DRUG

HLD200 methylphenidate hydrochloride capsules

Doses: 20mg capsules

DRUG

Placebo HLD200 capsules

Doses: 20mg capsules

Trial Locations (13)

29486

RECRUITING

HLD200-112 Study Site, Summerville

30030

RECRUITING

HLD200-112 Study Site, Decatur

32256

RECRUITING

HLD200-112 Study Site, Jacksonville

32801

RECRUITING

HLD200-112 Study Site, Orlando

33166

RECRUITING

HLD200-112 Study Site, Miami Springs

36303

RECRUITING

HLD200-112 Study Site, Dothan

38119

RECRUITING

HLD200-112 Study Site, Memphis

45219

RECRUITING

University of Cincinnati Health, Cincinnati

63304

RECRUITING

HLD200-112 Study Site, Saint Charles

68526

RECRUITING

HLD200-112 Study Site, Lincoln

70115

RECRUITING

HLD200-112 Study Site, New Orleans

89128

RECRUITING

HLD200-112 Study Site, Las Vegas

92805

RECRUITING

HLD200-112 Study Site, Anaheim

All Listed Sponsors
collaborator

Collegium Pharmaceutical, Inc.

INDUSTRY

lead

Ironshore Pharmaceuticals and Development, Inc

OTHER

NCT06431256 - Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years with ADHD | Biotech Hunter | Biotech Hunter