Clinical trial NCT04866043: Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder
Official title: Drug Utilization Study With VYVANSE® in Australia for Binge Eating Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge-eating Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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).

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.

Primary outcomes:
measure: Number of Participants Based on Indication of Use of Lisdexamfetamine Dimesylate
timeFrame: Up to 36 months
Secondary outcomes:
measure: Number of Participants Based on Patterns of Drug Use
timeFrame: Up to 36 months
measure: Number of Participants Based on Average Daily Dose
timeFrame: Up to 36 months
measure: Number of Participants Based on Maximum Daily Dose
timeFrame: Up to 36 months
measure: Number of Participants Based on Co-prescription
timeFrame: Up to 36 months
measure: Number of Participants Based on Co-diagnosis
timeFrame: Up to 36 months
measure: Number of Prescriptions of Lisdexamfetamine Dimesylate
timeFrame: Up to 36 months
measure: Treatment Duration
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Site
state: New South Wales
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: