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NCT05670860: PRO-CON

Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022

Status unknown Last updated 4 January 2023
What this trial tests

trial in Anti-epileptic Prophylaxis in Intracranial Neurosurgery in 700 participants. Status unknown.

Timeline
22 November 2022
Primary endpoint
22 May 2023
22 May 2023

Quick facts

Lead sponsorUniversity Hospital, Brest
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment700
Start date22 November 2022
Primary completion22 May 2023
Estimated completion22 May 2023
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Brest

Who can join

18 and older, any sex, with Anti-epileptic Prophylaxis in Intracranial Neurosurgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

JUSTIFICATION Anti-epileptic prophylaxis has long been a systematic practice for supra-tentorial intracranial surgeries. Since 2021, European guidelines no longer recommend this prophylaxis and practices have evolved. We therefore propose to compare epileptic seizure's occurrence in the first postoperative month between two groups of neurosurgical patients.The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis. Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis. The secondary objective will consist in identifying the number of patients placed on prophylaxis, the length of prophylaxis, treatment's side effects (depression, elevated liver enzymes…), and comparing patients' neurological outcome at 3 and 6 months after surgical procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University Hospital, Brest trials

Trials by the same sponsor.

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Data sources for this page

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