Drug utilization study with VYVANSE® (lisdexamfetamine dimesilate) in Australia for Binge Eating Disorder

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47852
• EU PAS number:
  EUPAS40690
• Study ID:
  47852
• Official title and acronym:
  Drug utilization study with VYVANSE® (lisdexamfetamine dimesilate) in Australia for Binge Eating Disorder
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Shire

Study timelines

Date when funding contract was signed

Actual: 09/05/2017

Study start date

Actual: 01/06/2019

Data analysis start date

Actual: 01/08/2019

Date of interim report, if expected

Actual: 30/10/2020

Date of final study report

Actual: 15/10/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Shire

Study protocol

Initial protocol

SHP489-827-protocol-original-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

CT.gov: NCT04866043,To obtain more information on the study, click here/on this link: https://clinicaltrials.takeda.com/study-detail/60901ad9f89629001e47b504