Symptomatic EpilepsyOPERANCT06383689
Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring
A study of Symptomatic Epilepsy, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Epilepsy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 13 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eligibility for presurgical epilepsy diagnostics
Who cannot join
- inclusion criterion implies all exclusion criteria for this procedure
- legal guardian
- lack of consent or lack of capability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Epileptology, University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Rainer Surges, Prof., +49 228 287-15727, rainer.surges@ukbonn.de
Christian Hoppe, PD Dr., +49 228 287-16172, christian.hoppe@ukbonn.de
About this study
Official title: Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)
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.
Read the detailed description
Patients undergoing long-term video-EEG monitoring for the purpose of pre-operative epilepsy diagnostics will be invited to participate in the study. Patients will be pseudo-randomized into three study conditions (in blocks of six). The study participants will take a placebo pill designated either as a "seizure pill" (Condition PCB-S) or a "comfort pill" (PCB-W) in addition to their regular medication in the morning and evening, or not receive any additional placebo medication (No-PCB).
Both the "seizure pill" and the "comfort pill" are commercially available, ingredient-free placebo pills (P-pills blue Lichtenstein, produced by Winthrop Pharmaceuticals). No further details about the composition of the pill will be provided; information about the ingredients of the respective pill will be provided after the end of the entire study. Depending on randomization, study participants will be informed that this pill is expected to (1) either facilitate/accelerate the occurrence of epileptic seizures (PCB-S) (thereby shortening the required time for video-EEG monitoring), or (2) to lead to a more stable/improved emotional well-being during the stay in the V-EEG (PCB-W) or (3) will not receive a pill but are asked to fill-in questionnaires and diaries like the other patients.Start of the V-EEG will be documented as the starting point for latency measurement for the occurrence of a first epileptic seizure. The patients will be pseudo-randomized into the three study conditions: Out of every 6 patients, 2 will be assigned to each of the three study conditions. Patients in both active study conditions will receive the first pill at the start of the V-EEG. After that, study participants will receive the respective "pill" morning and evening in addition to their other medications, however, visibly separated from them and clearly marked as study medication. All participants, including controls, will keep a seizure diary during the V-EEG. In addition, they will fill-in a newly constructed ad-hoc questionnaire at the beginning and after the V-EEG. Finally, all patients will be asked twice daily (around 9 AM and around 6 PM) about their overall emotional well-being using a visual analogue scale (VAS; 0 very bad ... 100 extremely good). The highly standardized clinical procedures of presurgical evaluation are in no way affected by the study. In particular, anti-seizure medications for all patients will be tapered off following exactly the same schedule without any influence from the study; the medication will be precisely documented.
- Conditions
- Symptomatic Epilepsy
- Being tested
- Seizure placebo pill, Well-being placebo pill
- Keywords
- epilepsy, emotional well-being, placebo, video-EEG long-term monitoring, presurgical epilepsy diagnostics
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seizure placebo pillOther
Also called PCB-S
patients in this study arm receive a covered placebo pill on a daily basis (1-0-1) with the indication of possible acceleration of seizure occurrence during presurgical video-EEG
Well-being placebo pillOther
Also called PCB-W
patients in this study arm receive a covered placebo pill on a daily basis (1-0-1) with the indication of possible improvement of emotional well-being during video-EEG
| Study group | Role | What they receive |
|---|---|---|
| Seizure placebo pill (PCB-S) | Experimental | Patients assigned to this condition receive a covered placebo pill (1-0-1) on a daily basis with the indication of possible acceleration of the occurrence of an epileptic seizure (which then allows to conclude V-EEG monitoring faster) Receives: Other: Seizure placebo pill |
| Well-being placebo pill (PCB-W) | Experimental | Patients assigned to this condition receive a covered placebo pill (1-0-1) on a daily basis with the indication of possible improvement of emotional well-being during the demanding V-EEG monitoring procedure Receives: Other: Well-being placebo pill |
| No pill (control) | No intervention | Patients assigned to this condition receive no study pill but are asked to fill-in all questionnaires and diaries like patients in the two active arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to first epileptic seizure
temporal latency from beginning of the video-EEG monitoring to the occurrence of the first epileptic seizure
Measured: immediately after video-EEG monitoring
Secondary outcomes (10)
Occurrence of an epileptic seizure
Occurrence of an epileptic seizure during the video-EEG (yes/no)
Measured: immediately after video-EEG monitoring
Early occurrence of an epileptic seizure within the first 72 hours
Early occurrence of an epileptic seizure within the first 72 hours of video-EEG monitoring (yes/no)
Measured: immediately after video-EEG monitoring
Number of epileptic seizures during the video-EEG
Total number of epileptic seizures which occurred during the video-EEG
Measured: immediately after video-EEG monitoring
Number of early occurring epileptic seizures
Total number of epileptic seizures recorded during the first 72 hours of video-EEG
Measured: 72 hours after video-EEG monitoring
Daily average frequency of epileptic seizures
Average daily frequency of epileptic seizures during the entire video-EEG (calculated)
Measured: immediately after video-EEG monitoring
Very early first epileptic seizure
First epileptic seizure on the first day of video-EEG (yes/no)
Measured: after 1st day after video-EEG monitoring
Early epileptic seizure
First epileptic seizure on the first or second day of video-EEG (yes/no)
Measured: after 2nd day after video-EEG monitoring
Epileptic seizure within the first three days
First epileptic seizure within the first three days of video-EEG (yes/no).
Measured: after 3rd day after video-EEG monitoring
Emotional well-being
Visual analogue scales (diary), 2x daily queries (9 am, 6 pm): mean and standard deviation (stability), during the video-EEG
Measured: immediately after video-EEG monitoring
Dissociative non-epileptic seizures
occurrence of dissociative non-epileptic seizures during video-EEG (yes/no)
Measured: immediately after video-EEG monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start13 May 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic EpilepsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- monocentric single-blinded randomized clinical study on the effectiveness of covered placebo on epileptic seizure occurrence and emotional well-being with 3 study conditions: "seizure pill" (PCB-S), "well-being pill" (PCB-W) and no pill (control)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Hoppe, University Hospital, Bonn
- Investigators
- Rainer Surges, Prof., Principal investigator, Department of Epileptology, University Hospital Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383689
- Sponsor's protocol ID
- Az. 297/23-EP
- Acronym
- OPERA
- Status last verified
- Jun 2024
- First submitted
- 10 Apr 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)
- ClinicalTrials.gov ID
- NCT06383689
- Acronym / sponsor ID
- OPERA / Az. 297/23-EP
- Conditions
- Symptomatic Epilepsy
- Keywords
- epilepsy, emotional well-being, placebo, video-EEG long-term monitoring, presurgical epilepsy diagnostics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2024 (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.
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.
Detailed description
Patients undergoing long-term video-EEG monitoring for the purpose of pre-operative epilepsy diagnostics will be invited to participate in the study. Patients will be pseudo-randomized into three study conditions (in blocks of six). The study participants will take a placebo pill designated either as a "seizure pill" (Condition PCB-S) or a "comfort pill" (PCB-W) in addition to their regular medication in the morning and evening, or not receive any additional placebo medication (No-PCB).
Both the "seizure pill" and the "comfort pill" are commercially available, ingredient-free placebo pills (P-pills blue Lichtenstein, produced by Winthrop Pharmaceuticals). No further details about the composition of the pill will be provided; information about the ingredients of the respective pill will be provided after the end of the entire study. Depending on randomization, study participants will be informed that this pill is expected to (1) either facilitate/accelerate the occurrence of epileptic seizures (PCB-S) (thereby shortening the required time for video-EEG monitoring), or (2) to lead to a more stable/improved emotional well-being during the stay in the V-EEG (PCB-W) or (3) will not receive a pill but are asked to fill-in questionnaires and diaries like the other patients.Start of the V-EEG will be documented as the starting point for latency measurement for the occurrence of a first epileptic seizure. The patients will be pseudo-randomized into the three study conditions: Out of every 6 patients, 2 will be assigned to each of the three study conditions. Patients in both active study conditions will receive the first pill at the start of the V-EEG. After that, study participants will receive the respective "pill" morning and evening in addition to their other medications, however, visibly separated from them and clearly marked as study medication. All participants, including controls, will keep a seizure diary during the V-EEG. In addition, they will fill-in a newly constructed ad-hoc questionnaire at the beginning and after the V-EEG. Finally, all patients will be asked twice daily (around 9 AM and around 6 PM) about their overall emotional well-being using a visual analogue scale (VAS; 0 very bad ... 100 extremely good). The highly standardized clinical procedures of presurgical evaluation are in no way affected by the study. In particular, anti-seizure medications for all patients will be tapered off following exactly the same schedule without any influence from the study; the medication will be precisely documented.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- monocentric single-blinded randomized clinical study on the effectiveness of covered placebo on epileptic seizure occurrence and emotional well-being with 3 study conditions: "seizure pill" (PCB-S), "well-being pill" (PCB-W) and no pill (control)
| Arm | Type | Receives |
|---|---|---|
| Seizure placebo pill (PCB-S) | Experimental | Other: Seizure placebo pillPatients assigned to this condition receive a covered placebo pill (1-0-1) on a daily basis with the indication of possible acceleration of the occurrence of an epileptic seizure (which then allows to conclude V-EEG monitoring faster) |
| Well-being placebo pill (PCB-W) | Experimental | Other: Well-being placebo pillPatients assigned to this condition receive a covered placebo pill (1-0-1) on a daily basis with the indication of possible improvement of emotional well-being during the demanding V-EEG monitoring procedure |
| No pill (control) | No intervention | –Patients assigned to this condition receive no study pill but are asked to fill-in all questionnaires and diaries like patients in the two active arms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- eligibility for presurgical epilepsy diagnostics
Key exclusion criteria (3 listed)
- inclusion criterion implies all exclusion criteria for this procedure
- legal guardian
- lack of consent or lack of capability to provide informed consent
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 |
|---|---|---|
| Seizure placebo pillAlso: PCB-Spatients in this study arm receive a covered placebo pill on a daily basis (1-0-1) with the indication of possible acceleration of seizure occurrence during presurgical video-EEG | Other | Seizure placebo pill (PCB-S) |
| Well-being placebo pillAlso: PCB-Wpatients in this study arm receive a covered placebo pill on a daily basis (1-0-1) with the indication of possible improvement of emotional well-being during video-EEG | Other | Well-being placebo pill (PCB-W) |
Primary outcome
Latency to first epileptic seizure
Time frame: immediately after video-EEG monitoring
temporal latency from beginning of the video-EEG monitoring to the occurrence of the first epileptic seizure
10 secondary outcomes
Occurrence of an epileptic seizure
Time frame: immediately after video-EEG monitoring
Early occurrence of an epileptic seizure within the first 72 hours
Time frame: immediately after video-EEG monitoring
Number of epileptic seizures during the video-EEG
Time frame: immediately after video-EEG monitoring
Number of early occurring epileptic seizures
Time frame: 72 hours after video-EEG monitoring
Daily average frequency of epileptic seizures
Time frame: immediately after video-EEG monitoring
Very early first epileptic seizure
Time frame: after 1st day after video-EEG monitoring
Early epileptic seizure
Time frame: after 2nd day after video-EEG monitoring
Epileptic seizure within the first three days
Time frame: after 3rd day after video-EEG monitoring
Emotional well-being
Time frame: immediately after video-EEG monitoring
Dissociative non-epileptic seizures
Time frame: immediately after video-EEG monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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.
Rainer Surges, Prof. principal investigator
Department of Epileptology, University Hospital Bonn, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Symptomatic Epilepsy, run by University Hospital, Bonn at 1 site in Germany.
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 3 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: looking for participants now, as of the sponsor's last update on 10 Jun 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rainer Surges, Prof. (+49 228 287-15727, rainer.surges@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency to first epileptic seizure (time frame: immediately after video-EEG monitoring). 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 10 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.