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

NCT02255565 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-08-01

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Mark Stein, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-09-30
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255565 on ClinicalTrials.gov