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A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide

NCT01977651 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2024-12-06

Study results available
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Summary

The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for seizure.

Conditions

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

DRUG

Enzalutamide

Participants received 4 capsules (40 mg each) of enzalutamide orally once a day, for a total daily dose of 160 mg. Treatment was given with or without food and as close as possible to the same time each day.

Sponsors & Collaborators

  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Sr. Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-25
Primary Completion
2016-02-01
Completion
2019-01-11

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977651 on ClinicalTrials.gov