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OpenTrials
Completed

NCT Number: NCT05870605

Drug Use Study With Intuniv® in European Countries

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Real World Insights EMEA IQVIA Commercial GmbH & Co. OHG

Munich, Bavaria, 80637, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention

Other

This is an observational study utilizing historical de-identified patient level data; therefore no intervention is given.

Primary outcomes

  1. Number of Participants Stratified by Prescriber Information Based on Physician Survey

    Time frame: Up to 4 years

    Participants will be stratified based on prescriber information which include demographics, specialty, and setting of prescriber.

  2. Number of Participants Categorised Based on Their Demographic Characteristics

    Time frame: Up to 4 years

    The demographic characteristics will include age and gender.

  3. Number of Participants with Co-morbidities

    Time frame: Up to 4 years

  4. Number of Participants Based on Indication of Use of Prescribed Intuniv®

    Time frame: Up to 4 years

    Indication of use (diagnosis) will be assessed as per World Health Organization (WHO) 10th International Statistical Classification of Diseases and Related Health Problems (ICD) classification.

  5. Number of Participants With ADHD Categorised Based on Different Patterns of Intuniv® Use

    Time frame: Up to 4 years

    Patterns of drug use include first time users, repeat users, participants who discontinued the ADHD therapy, participants with switches in treatment (both from Intuniv® to other ADHD medications and other ADHD medications to Intuniv®), and participants with dosing/overdose (defined as daily dose of >7 mg or of >4mg in participants ≤12 years of age).

  6. Number of Participants Using Intuniv® as Second Line Treatment After Psychostimulant Prescription at any Time Prior to the Participant's First Prescription of Intuniv®

    Time frame: Up to 4 years

Secondary outcomes

  1. Number of Physician Visits During the First Year of Therapy

    Time frame: Up to 4 years

  2. Frequency of Weight Monitoring of Participants by Physician

    Time frame: Up to 4 years

    Frequency of weight monitoring of participants by physician will be reported.

  3. Frequency of Blood Pressure Monitoring of Participants by Physician

    Time frame: Up to 4 years

    Frequency of blood pressure monitoring of participants by physician will be reported.

  4. Frequency of Heart Rate Monitoring of Participants by Physician

    Time frame: Up to 4 years

    Frequency of heart rate monitoring of participants by physician will be reported.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) in European Countries

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 23, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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