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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

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).

Condition or disease Intervention/treatment
Prostate Cancer Neuropathy Epilepsy Encephalopathy Drug: Enzalutamide

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

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Study Type : Observational
Estimated Enrollment : 500000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025


Group/Cohort Intervention/treatment
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
Drug: Enzalutamide
Enzalutamide for the treatment of prostate cancer or other solid tumors




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with enzalutamide for prostate cancer or other solid tumors
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290611


Locations
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France
Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
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Responsible Party: Joe Elie Salem, Principal Investigator, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT04290611    
Other Study ID Numbers: CIC1421-20-02
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
Drug-induced neurotoxicity
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases