A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting

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.

Timeline

Start

2015-08

Primary completion

2016-04

Completion

2016-05

Outcome

Missed primary endpoint

registry analysis (superiority test); HLD200 (Methylphenidate) vs Placebo; p = 0.05; Mixed model repeated measures analysis NCT02520388 ↗

Publications

• Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
• Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
• Wilens TE, Faraone SV, Hammerness PG, Pliszka SR, Uchida CL, DeSousa NJ, Sallee FR, Incledon B, Newcorn JH. Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate. J Atten Disord. 2022 Mar;26(5):696-705. doi: 10.1177/10870547211020073. Epub 2021 Jun 4.
• Lopez FA, Faraone SV, Newcorn JH, Doll HA, Rhoten S, Lewis HB, Khan TF, DeSousa NJ, Sallee FR, Incledon B. Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Apr;31(3):179-186. doi: 10.1089/cap.2020.0159. Epub 2021 Apr 1.

Drugs

Indications