Prostate CancerVENDYNCT04290611
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
An observational study of Prostate Cancer and Neuropathy, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prostate Cancer, Neuropathy, Epilepsy
- What is being tested?
- Enzalutamide
- How many people
- 500,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 8 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with enzalutamide for prostate cancer or other solid tumors
Who may be able to join
- 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.
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study
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).
Read the 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
- Being tested
- Enzalutamide
- Keywords
- Drug-induced neurotoxicity
- Medical subject headings
- Prostatic Neoplasms, Epilepsy, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Enzalutamide for the treatment of prostate cancer or other solid tumors
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with neurological adverse events with significant over-reporting enzalutamide
Identification and report of neurological toxiciy of enzalutamdie
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2023
- Study completion8 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290611
- Sponsor's protocol ID
- CIC1421-20-02
- Acronym
- VENDY
- Status last verified
- Apr 2023
- First submitted
- 27 Feb 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study
- ClinicalTrials.gov ID
- NCT04290611
- Acronym / sponsor ID
- VENDY / CIC1421-20-02
- Conditions
- Prostate Cancer, Neuropathy, Epilepsy, Encephalopathy
- Keywords
- Drug-induced neurotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500,000 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide drug-induced toxicity | – | Drug: EnzalutamideCases 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with enzalutamide for prostate cancer or other solid tumors
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnzalutamideEnzalutamide for the treatment of prostate cancer or other solid tumors | Drug | Enzalutamide drug-induced toxicity |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Neuropathy, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.