A Multicenter, Single-arm, Open-label, Post-marketing Safety Study to Evaluate the Risk of Seizure Among Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Enzalutamide Who Are at Potential Increased Risk of Seizure

Study identification

• EU PAS number:
  EUPAS5552
• Study ID:
  32806
• Official title and acronym:
  A Multicenter, Single-arm, Open-label, Post-marketing Safety Study to Evaluate the Risk of Seizure Among Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Enzalutamide Who Are at Potential Increased Risk of Seizure
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Belgium

  Brazil

  Canada

  Chile

  Finland

  France

  Germany

  Greece

  Hong Kong

  Hungary

  Israel

  Italy

  Korea, Republic of

  New Zealand

  Singapore

  Spain

  Sweden

  Taiwan

  United Kingdom

  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Astellas Pharma Global Development, Inc.

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/01/2013

Actual: 15/01/2013

Study start date

Planned: 20/10/2013

Actual: 23/09/2013

Data analysis start date

Planned: 11/01/2019

Actual: 12/01/2019

Date of final study report

Planned: 15/08/2019

Actual: 24/07/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Global Development, Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)