NCT04290611

a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500,000 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer
• Neuropathy
• Epilepsy
• Encephalopathy

Interventions

Type	Name	Description
DRUG	Enzalutamide	Enzalutamide for the treatment of prostate cancer or other solid tumors

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-01-01
• Completion: 2023-04-08
• First posted: 2020-03-02
• Last updated: 2023-04-13

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study