NCT02255565

Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study

Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Quillivant XR is effective in the treatment of ADHD in children with Autism Spectrum Disorder (ASD).

Detailed description

To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in children with ASD and ADHD. The investigators propose to investigate the low to moderate dose range of methylphenidate compared with a very low dose with a gradual dose escalation schedule because children with ASD have been found to be more sensitive to the adverse effects of methylphenidate (especially in medium to high doses) than children without ASD.

Conditions

• ADHD
• Autism

Interventions

Type	Name	Description
DRUG	Very Low Dose Quillivant XR	Oral suspension dose once a day increasing to a 10mg dose
DRUG	Low Dose Quillivant XR	Oral suspension dose once a day increasing to a 20mg dose
DRUG	Moderate Dose Quillivant XR	Oral suspension dose once a day increasing to a 40mg dose

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2014-10-02
• Last updated: 2017-08-01
• Results posted: 2017-06-05

Locations

1 site across 1 country: United States