Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 4

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

NCT01977651 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Enzalutamide

Study Locations (20)

New York

  • Site US10001 — New York
  • Site US10014 — New York
  • Site US10039 — Syracuse
  • Site US10026 — The Bronx

New South Wales

  • Site AU61012 — Kogarah
  • Site AU61005 — Randwick
  • Site AU61011 — Sydney
  • Site AU61001 — Tweed Heads

Other

  • Site AR54003 — Córdoba
  • Site AR54005 — San Miguel de Tucumán
  • Site AR54004 — Santa Fe

Buenos Aires

  • Site AR54001 — Berazategui
  • Site AR54006 — Ciudad Autonoma de BuenosAires

Alaska

  • Site US10005 — Anchorage

Michigan

  • Site US10024 — Detroit

North Carolina

  • Site US10016 — Durham

Texas

  • Site US10008 — Dallas

Trial Details

FieldValue
Enrollment Target 424 participants
Start Date 2013-09-25
Est. Completion 2019-01-11
Phase Phase 4

Sponsor

Astellas Pharma Global Development

172 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01977651

The ClinicalTrials.gov registry entry for NCT01977651 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Castration-resistant Prostate Cancer (mCRPC) appearing as the primary indexed condition, and to 1 intervention — of which Enzalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01977651 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, New South Wales, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01977651 about?

NCT01977651 is a clinical study titled "A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide". 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.

What is the current status of trial NCT01977651?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 424 participants. The study started on 2013-09-25. Estimated completion is 2019-01-11.

What conditions does trial NCT01977651 study?

This clinical trial studies the following conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01977651?

The interventions under investigation include: Enzalutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01977651?

This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01977651 being conducted?

This trial has 20 study locations across Alaska, Michigan, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial