NCT03327402 - Safety, Tolerability and Pharmacokinetics of SHP465 in Children Aged 4 to 5 Years With Attention-Deficit/Hyperactivity Disorder (ADHD) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 13, 2018

Primary Completion Date

October 5, 2018

Study Completion Date

October 5, 2018

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

SHP465

SHP465 capsule will be administered at a dose of 6.25 mg, orally once daily for 4 weeks. SHP465 is comprised of sulfate salts of dextroamphetamine and amphetamine, with dextroamphetamine saccharate and amphetamine aspartate monohydrate, which provide a composite enantiomer ratio of 3:1 d-amphetamine to l-amphetamine.

Trial Locations (8)

29464

Coastal Pediatric Associates, Mt. Pleasant

32801

Clinical Neuroscience Solutions Inc, Orlando

38119

Clinical Neuroscience Solutions Inc, Memphis

44106

University Hospitals Cleveland Medical Center, Cleveland

45040

Professional Psychiatric Services (PPS), Mason

45414

Ohio Pediatric Research Assn Inc, Dayton

47715

Qualmedica Research, LLC, Evansville

72211

Preferred Research Partners, Little Rock