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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04866043




Registration number
NCT04866043
Ethics application status
Date submitted
28/04/2021
Date registered
29/04/2021

Titles & IDs
Public title
Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder
Scientific title
Drug Utilization Study With VYVANSE® in Australia for Binge Eating Disorder
Secondary ID [1] 0 0
EUPAS40690
Secondary ID [2] 0 0
SHP489-827
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Binge-eating Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Eating disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Based on Indication of Use of Lisdexamfetamine Dimesylate
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [1] 0 0
Number of Participants Based on Patterns of Drug Use
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Number of Participants Based on Average Daily Dose
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Number of Participants Based on Maximum Daily Dose
Timepoint [3] 0 0
Up to 36 months
Secondary outcome [4] 0 0
Number of Participants Based on Co-prescription
Timepoint [4] 0 0
Up to 36 months
Secondary outcome [5] 0 0
Number of Participants Based on Co-diagnosis
Timepoint [5] 0 0
Up to 36 months
Secondary outcome [6] 0 0
Number of Prescriptions of Lisdexamfetamine Dimesylate
Timepoint [6] 0 0
Up to 36 months
Secondary outcome [7] 0 0
Treatment Duration
Timepoint [7] 0 0
Up to 36 months

Eligibility
Key inclusion criteria
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).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/10/2021
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Site - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Shire
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04866043