Clinical Trial

Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring

Study acronym: OPERA
Recruiting
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Record status
This record was last updated June 10, 2024 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The notion of genuine placebo effects on epileptic seizure events (i.e., effects beyond methodological study artifacts) is incompatible with the standard model of epilepsy seizure genesis. In this single-blind controlled study, the effectiveness of a covered placebo on (1) the timing of the occurrence of a first epileptic seizure ("seizure pill") versus (2) the subjective well-being ("comfort pill") during pre-surgical video-EEG monitoring will be examined. It is hypothesized that a placebo effect on subjective well-being can be demonstrated, but that epileptic seizure events are not influenced by placebo.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-04-22.
Status change: Not Yet Recruiting → Recruiting 2024-06-07
Trial Details
NCT Number NCT06383689
Lead Sponsor University Hospital, Bonn
Conditions Symptomatic Epilepsy
Enrollment 90 participants
Start Date 2024-05-13
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-06-10