Drug Use Study With Intuniv® in European Countries

Shire

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05870605

SHP503-802

EUPAS18739 (Other Identifier)

EUPAS18735 (Other Identifier)

Details and patient eligibility

About

This study will evaluate and characterize people who are taking Intuniv, analyze prescribing behaviors of physicians, and determine whether Intuniv was correctly prescribed in Belgium, Denmark, Finland, Germany, Ireland, Netherlands, Norway, Spain, Sweden, and the United Kingdom.

Full description

The study aims to characterize participants who are prescribed Intuniv® and describe prescribing patterns of Intuniv® among physicians in European countries.

This study will collect data from the following sources:

• Physician Survey: de-identified patient data provided by representative physicians in Belgium, Finland, Ireland, and the Netherlands, with a goal of data from up to 100 participants per survey wave.
• Database Survey: longitudinal patient-level prescription database in all other countries with data on approximately 5000 participants.

In the database study, actual prescription data are collected from electronic medical records and national registries. A prescriber survey will be conducted to evaluate health care professionals (HCPs) real-life practice. It will include data collection from the prescriber's (physician's) files and a web questionnaire, including de-identified data from up to 100 participants per survey wave.

Enrollment: 5,000 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prescribers of Intuniv®, i.e. physicians who know and have prescribed the drug at least once during the previous 12 months (or, for the first report, since country specific launch) (paediatricians, psychiatrists, neurologists and GPs).
• Participants who have been prescribed Intuniv® at least once during the reporting period.

Exclusion criteria

• Physicians who do not treat participants or who may have a conflict of interest (i.e. physicians employed by regulatory bodies or pharmaceutical industries).

Trial design

5,000 participants in 2 patient groups

Database Survey

Description:

All prescriptions for Intuniv available in the database in Denmark, Germany, Norway, Spain, Sweden, and the United Kingdom will be analyzed.

Treatment:

Other: No Intervention

Physician Survey

Description:

The physicians will collect participant records of those who have been prescribed Intuniv® at least once during the study period of 4 years. This will be done in Belgium, Finland, Ireland, and the Netherlands.

Treatment:

Other: No Intervention