Attention Deficit Hyperactivity Disorder (ADHD)NCT05870605
Drug Use Study With Intuniv® in European Countries
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2018to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prescribers of Intuniv® in the European countries.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Real World Insights EMEA IQVIA Commercial GmbH & Co. OHG
Munich, Bavaria, 80637
About this study
Official title: Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) 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.
Read the detailed 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.
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is an observational study utilizing historical de-identified patient level data; therefore no intervention is given.
| Study group | Role | What they receive |
|---|---|---|
| Database Survey | All prescriptions for Intuniv available in the database in Denmark, Germany, Norway, Spain, Sweden, and the United Kingdom will be analyzed. Receives: Other: No Intervention | |
| Physician Survey | 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Stratified by Prescriber Information Based on Physician Survey
Participants will be stratified based on prescriber information which include demographics, specialty, and setting of prescriber.
Measured: Up to 4 years
Number of Participants Categorised Based on Their Demographic Characteristics
The demographic characteristics will include age and gender.
Measured: Up to 4 years
Number of Participants with Co-morbidities
Measured: Up to 4 years
Number of Participants Based on Indication of Use of Prescribed Intuniv®
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.
Measured: Up to 4 years
Number of Participants With ADHD Categorised Based on Different Patterns of Intuniv® Use
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).
Measured: Up to 4 years
Number of Participants Using Intuniv® as Second Line Treatment After Psychostimulant Prescription at any Time Prior to the Participant's First Prescription of Intuniv®
Measured: Up to 4 years
Secondary outcomes (4)
Number of Physician Visits During the First Year of Therapy
Measured: Up to 4 years
Frequency of Weight Monitoring of Participants by Physician
Frequency of weight monitoring of participants by physician will be reported.
Measured: Up to 4 years
Frequency of Blood Pressure Monitoring of Participants by Physician
Frequency of blood pressure monitoring of participants by physician will be reported.
Measured: Up to 4 years
Frequency of Heart Rate Monitoring of Participants by Physician
Frequency of heart rate monitoring of participants by physician will be reported.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start15 Nov 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870605
- Sponsor's protocol ID
- SHP503-802
- Other IDs
- EUPAS18739, EUPAS18735
- Status last verified
- Aug 2023
- First submitted
- 12 May 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) in European Countries
- ClinicalTrials.gov ID
- NCT05870605
- Acronym / sponsor ID
- SHP503-802
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Database Survey | – | Other: No InterventionAll prescriptions for Intuniv available in the database in Denmark, Germany, Norway, Spain, Sweden, and the United Kingdom will be analyzed. |
| Physician Survey | – | Other: No InterventionThe 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prescribers of Intuniv® in the European countries.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Physicians who do not treat participants or who may have a conflict of interest (i.e. physicians employed by regulatory bodies or pharmaceutical industries).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is an observational study utilizing historical de-identified patient level data; therefore no intervention is given. | Other | Database Survey, Physician Survey |
Primary outcome
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.
Number of Participants Categorised Based on Their Demographic Characteristics
Time frame: Up to 4 years
The demographic characteristics will include age and gender.
Number of Participants with Co-morbidities
Time frame: Up to 4 years
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.
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).
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
4 secondary outcomes
Number of Physician Visits During the First Year of Therapy
Time frame: Up to 4 years
Frequency of Weight Monitoring of Participants by Physician
Time frame: Up to 4 years
Frequency of Blood Pressure Monitoring of Participants by Physician
Time frame: Up to 4 years
Frequency of Heart Rate Monitoring of Participants by Physician
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Related trials for Attention Deficit Hyperactivity Disorder (ADHD)
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Shire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Stratified by Prescriber Information Based on Physician Survey (time frame: Up to 4 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.