MedTrace Logo

Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children

NCT04987762 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2023-08-22

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the long-term safety of Adhansia XR in children and to characterize the pharmacokinetics (PK) in 4 to 5 year-olds.

Conditions

  • Attention Deficit/Hyperactivity Disorder

Interventions

DRUG

Adhansia XR

Methylphenidate extended-release capsules taken once daily (12.5 mg, 25 mg, 35 mg, 45 mg, 55 mg, and 70 mg)

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2022-04-27
Completion
2022-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04987762 on ClinicalTrials.gov