Binge-eating DisorderNCT04866043
Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder
An observational study of Binge-eating Disorder, run by Shire at 1 site in Australia.
Trial summary
This study will check how and to whom Vyvanse is prescribed in Australia by retrospectively analyzing a prescription database with additional information provided by a physician survey. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge-eating Disorder
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jun 2019to 15 Oct 2021
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants who have been prescribed lisdexamfetamine dimesylate at least once during the reporting period without evidence of use of lisdexamfetamine dimesylate for ADHD treatment.
Who may be able to join
- Main prescription data analysis:
- At least one prescription for lisdexamfetamine dimesylate recorded in the NostraData database in Australia.
- For all sensitivity analyses (sensitivity analysis I, II and III):
- At least one prescription for lisdexamfetamine dimesylate recorded in the NostraData database in Australia during the defined observation period of the study.
- Physician survey:
- The physician prescribed lisdexamfetamine dimesylate for indications other than ADHD in the last 12 months for at least one participant.
- Participant population:
- Physician entered data for the participant until at least question 3 (treatment information (Q03); main indication).
Who cannot join
- For all sensitivity analyses (sensitivity analysis I, II and III):
- Evidence of use for lisdexamfetamine dimesylate for treatment of ADHD, as shown by prescription records for ADHD medication other than lisdexamfetamine dimesylate at any time.
- Record of at least one lisdexamfetamine dimesylate prescription prior to launch of lisdexamfetamine dimesylate for BED (02/17/2018).
- Additional exclusion criteria for the specific sensitivity analyses:
- For sensitivity analysis I:
- Prescriptions for lisdexamfetamine dimesylate issued by pediatricians or child psychiatrists.
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- For sensitivity analysis II:
- Prescriptions for lisdexamfetamine dimesylate issued by all prescribers other than psychiatrists (example, pediatricians, general practitioner [GPs]).
- For sensitivity analysis III:
- Prescriptions for lisdexamfetamine dimesylate issued by pediatricians or child psychiatrists.
- For participants with age available, participants with evidence for age at first prescription below 18 years.
- Physician survey and participant population:
- Physician entered ADHD as main indication for prescription of lisdexamfetamine dimesylate (treatment information [Q03]) for the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Utilization Study With VYVANSE® in Australia for Binge Eating Disorder
This study will check how and to whom Vyvanse is prescribed in Australia by retrospectively analyzing a prescription database with additional information provided by a physician survey.
Read the detailed description
This is a drug utilization study (DUS) using cross-sectional database analysis of participants who are prescribed lisdexamfetamine dimesylate for treatment of BED. The study will combine data from two sources of patient-level drug utilization data for lisdexamfetamine dimesylate:
- NostraData database: Longitudinal participant level prescription dispensing database
- Physician survey: De-identified participant data provided by representative psychiatrists and other physicians expected to treat participants with BED in Australia.
In the NostraData database, actual drug dispensing data are collected, which allows for the generation of information on actual drug usage. However, these data do not contain certain participant variables, such as age and indication, needed to monitor potential off-label use. Therefore, these data must be supplemented with another data source. The physician survey will provide the data not included in the NostraData database.
The DUS will enroll approximately 150 participants.
This DUS will be conducted in Australia. The overall time for data collection in the study will be approximately 36 months after the launch date of lisdexamfetamine dimesylate.
- Conditions
- Binge-eating Disorder
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NostraData Database | All prescriptions for lisdexamfetamine dimesylate available in the NostraData database at any time in the last 12 months will be collected in Australia. | |
| Physician Survey | Physician will provide de-identified data of participants who have been prescribed lisdexamfetamine dimesylate at least once during the study period for indications other than attention deficit hyperactivity disorder (ADHD) in Australia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Based on Indication of Use of Lisdexamfetamine Dimesylate
Number of participants based on indication of use of Lisdexamfetamine Dimesylate will be assessed.
Measured: Up to 36 months
Secondary outcomes (7)
Number of Participants Based on Patterns of Drug Use
Number of participants based on patterns of drug use will be assessed.
Measured: Up to 36 months
Number of Participants Based on Average Daily Dose
Number of participants based on average daily dose will be assessed.
Measured: Up to 36 months
Number of Participants Based on Maximum Daily Dose
Number of participants based on maximum daily dose will be assessed.
Measured: Up to 36 months
Number of Participants Based on Co-prescription
Number of participants based on co-prescription of lisdexamfetamine dimesylate with monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), guanfacine hydrochloride and other central nervous system (CNS) stimulants will be assessed.
Measured: Up to 36 months
Number of Participants Based on Co-diagnosis
Number of participants based on co-diagnosis (BED and other indications except ADHD) will be assessed.
Measured: Up to 36 months
Number of Prescriptions of Lisdexamfetamine Dimesylate
Number of Prescriptions of lisdexamfetamine dimesylate will be evaluated.
Measured: Up to 36 months
Treatment Duration
Treatment duration will be defined as the length of time a participant remains on treatment.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Jun 2019
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-eating DisorderStudies 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
- 150 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
- NCT04866043
- Sponsor's protocol ID
- SHP489-827
- Other IDs
- EUPAS40690
- Status last verified
- Nov 2021
- First submitted
- 28 Apr 2021
- Last updated
- 22 Nov 2021
- 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 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Study With VYVANSE® in Australia for Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT04866043
- Acronym / sponsor ID
- SHP489-827
- Conditions
- Binge-eating Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 29 Apr 2021 (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 check how and to whom Vyvanse is prescribed in Australia by retrospectively analyzing a prescription database with additional information provided by a physician survey.
Detailed description
This is a drug utilization study (DUS) using cross-sectional database analysis of participants who are prescribed lisdexamfetamine dimesylate for treatment of BED. The study will combine data from two sources of patient-level drug utilization data for lisdexamfetamine dimesylate:
- NostraData database: Longitudinal participant level prescription dispensing database
- Physician survey: De-identified participant data provided by representative psychiatrists and other physicians expected to treat participants with BED in Australia.
In the NostraData database, actual drug dispensing data are collected, which allows for the generation of information on actual drug usage. However, these data do not contain certain participant variables, such as age and indication, needed to monitor potential off-label use. Therefore, these data must be supplemented with another data source. The physician survey will provide the data not included in the NostraData database.
The DUS will enroll approximately 150 participants.
This DUS will be conducted in Australia. The overall time for data collection in the study will be approximately 36 months after the launch date of lisdexamfetamine dimesylate.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NostraData Database | – | –All prescriptions for lisdexamfetamine dimesylate available in the NostraData database at any time in the last 12 months will be collected in Australia. |
| Physician Survey | – | –Physician will provide de-identified data of participants who have been prescribed lisdexamfetamine dimesylate at least once during the study period for indications other than attention deficit hyperactivity disorder (ADHD) in Australia. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants who have been prescribed lisdexamfetamine dimesylate at least once during the reporting period without evidence of use of lisdexamfetamine dimesylate for ADHD treatment.
Key inclusion criteria (8 listed)
- At least one prescription for lisdexamfetamine dimesylate recorded in the NostraData database in Australia.
- At least one prescription for lisdexamfetamine dimesylate recorded in the NostraData database in Australia during the defined observation period of the study.
- The physician prescribed lisdexamfetamine dimesylate for indications other than ADHD in the last 12 months for at least one participant.
- Physician entered data for the participant until at least question 3 (treatment information (Q03); main indication).
Key exclusion criteria (13 listed)
- Evidence of use for lisdexamfetamine dimesylate for treatment of ADHD, as shown by prescription records for ADHD medication other than lisdexamfetamine dimesylate at any time.
- Record of at least one lisdexamfetamine dimesylate prescription prior to launch of lisdexamfetamine dimesylate for BED (02/17/2018).
- Prescriptions for lisdexamfetamine dimesylate issued by pediatricians or child psychiatrists.
- Prescriptions for lisdexamfetamine dimesylate issued by all prescribers other than psychiatrists (example, pediatricians, general practitioner [GPs]).
- Prescriptions for lisdexamfetamine dimesylate issued by pediatricians or child psychiatrists.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Based on Indication of Use of Lisdexamfetamine Dimesylate
Time frame: Up to 36 months
Number of participants based on indication of use of Lisdexamfetamine Dimesylate will be assessed.
7 secondary outcomes
Number of Participants Based on Patterns of Drug Use
Time frame: Up to 36 months
Number of Participants Based on Average Daily Dose
Time frame: Up to 36 months
Number of Participants Based on Maximum Daily Dose
Time frame: Up to 36 months
Number of Participants Based on Co-prescription
Time frame: Up to 36 months
Number of Participants Based on Co-diagnosis
Time frame: Up to 36 months
Number of Prescriptions of Lisdexamfetamine Dimesylate
Time frame: Up to 36 months
Treatment Duration
Time frame: Up to 36 months
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 Nov 2021.
- 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.
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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 Binge-eating Disorder, run by Shire at 1 site in Australia.
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 8 inclusion and 13 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 Nov 2021. 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 Australia. 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 Based on Indication of Use of Lisdexamfetamine Dimesylate (time frame: Up to 36 months). 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 Nov 2021.