Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder

Binge-eating Disorder Clinical Trial

Official title:

Drug Utilization Study With VYVANSE® in Australia for Binge Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866043
• Other study ID #: SHP489-827
• Secondary ID: EUPAS40690
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: October 15, 2021

Study information

• Verified date: November 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Binge-eating Disorder
• Bulimia
• Feeding and Eating Disorders

Locations

Country	Name	City	State
Australia	Site	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 36 months
Secondary	Number of Participants Based on Patterns of Drug Use	Number of participants based on patterns of drug use will be assessed.	Up to 36 months
Secondary	Number of Participants Based on Average Daily Dose	Number of participants based on average daily dose will be assessed.	Up to 36 months
Secondary	Number of Participants Based on Maximum Daily Dose	Number of participants based on maximum daily dose will be assessed.	Up to 36 months
Secondary	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.	Up to 36 months
Secondary	Number of Participants Based on Co-diagnosis	Number of participants based on co-diagnosis (BED and other indications except ADHD) will be assessed.	Up to 36 months
Secondary	Number of Prescriptions of Lisdexamfetamine Dimesylate	Number of Prescriptions of lisdexamfetamine dimesylate will be evaluated.	Up to 36 months
Secondary	Treatment Duration	Treatment duration will be defined as the length of time a participant remains on treatment.	Up to 36 months

External Links

•   To obtain more information on the study, click here/on this link