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a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY (VENDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04290611
Recruitment Status : Active, not recruiting
First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

Tracking Information
First Submitted Date February 27, 2020
First Posted Date March 2, 2020
Last Update Posted Date March 2, 2020
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2020)
Number of patients with neurological adverse events with significant over-reporting enzalutamide [ Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 ]
Identification and report of neurological toxiciy of enzalutamdie
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
Official Title Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study
Brief Summary Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
Detailed Description Enzalutamide are responsible of a wide range of side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with enzalutamide
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with enzalutamide for prostate cancer or other solid tumors
Condition
  • Prostate Cancer
  • Neuropathy
  • Epilepsy
  • Encephalopathy
Intervention Drug: Enzalutamide
Enzalutamide for the treatment of prostate cancer or other solid tumors
Study Groups/Cohorts Enzalutamide drug-induced toxicity
Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by enzalutamide, with a chronology compatible with the drug toxicity
Intervention: Drug: Enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 27, 2020)
500000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2020 Adverse events reported were including any MedDRA terms Patients treated with enzalutamide reported in the WHO database.

Exclusion Criteria:

  • Chronology not compatible between the drug and the toxicity
Sex/Gender
Sexes Eligible for Study: All
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04290611
Other Study ID Numbers CIC1421-20-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
Study Sponsor Groupe Hospitalier Pitie-Salpetriere
Collaborators Not Provided
Investigators Not Provided
PRS Account Groupe Hospitalier Pitie-Salpetriere
Verification Date February 2020