At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 424 enrolled
Drug / intervention
Enzalutamidedrug
Likely dose
Enzalutamide 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Single-arm, Open-label, Postmarketing 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
In Brief
A Phase 4 clinical trial evaluating Enzalutamide for Metastatic Castration-resistant Prostate Cancer (mCRPC). Completed, enrolled 424 participants across 76 sites in 20 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Canada, Chile, Czechia, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedNov 2013
Primary CompletionFeb 2016
Study CompletionJan 2019
TodayJul 2026
First PostedNov 7, 2013
Enrollment StartSep 25, 2013
Primary CompletionFeb 1, 2016
Study CompletionJan 11, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.7 years ago
Interventions
Enzalutamidedrug
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.