Epilepsy trial software
The epilepsy endpoint is a count from a diary, divided by the days the diary was filled in. Capture runs the diary, the baseline, the titration and the safety review in one audit-trailed study. Build and test free.
- Seizure diary by type
- Baseline to maintenance
- Rescue medication log
Free sandbox · No credit card · 21 CFR Part 11 compliant
weeks
Diary only, stable medication
Dose raised on a fixed schedule
Fixed dose
Per protocol
What an epilepsy trial needs from its EDC
- The endpoint is built from a diary: registered adjunctive trials use percent change in seizure frequency per 28 days from baseline, and the 50% responder rate (at least half the seizures gone). Sponsor documents show some programmes using one as the US primary and the other as the EU primary; confirm which your regulators expect.
- Per-28-day normalisation depends on valid diary days: counts are divided by days with valid diary data and multiplied by 28, so missing days must be recorded, not left as zero.
- Seizure type matters: ILAE classification (focal aware, focal impaired awareness, focal to bilateral tonic-clonic, generalised types) decides which seizures count toward the endpoint.
- Medication stability is an eligibility and compliance question: baseline requires stable antiseizure medication, so every change in dose or drug must be dated.
- Safety beyond the diary: suicidality screening, cognitive and coordination effects, rash, status epilepticus, rescue medication use and rare deaths including SUDEP need their own fields.
The diary is the endpoint
From a seizure count to a 28-day frequency you can defend
Registered adjunctive trials of antiseizure medications (ganaxolone, lacosamide, cenobamate, perampanel and others) define the endpoint in the statistical analysis plan the same way: number of seizures in the period, divided by the number of days with valid diary data, multiplied by 28. Baseline lengths of four to eight weeks appear in these plans, and responders are participants whose frequency per 28 days falls by at least 50% from baseline. Sponsor documents for some programmes show the percent change in 28-day frequency as the FDA primary and the 50% responder rate as the EMA primary. Neither guidance text was retrieved for this page, so treat that as a pattern to check with your regulatory team, not a rule.
The arithmetic exposes the main data risks. If a diary day is blank, is it a seizure-free day or a day nobody wrote? Counting it as zero inflates responder rates; dropping it shrinks the denominator. The cleanest design is a daily entry that must be completed either with a count by seizure type or with an explicit seizure-free answer, with unmarked days remaining as missing. Capture diaries open from a secure link in the participant or caregiver phone browser, with reminders, and the compliance page for diaries describes how completion is tracked. See seizure diary template, patient diary software and ePRO compliance and diary completion rates. A caregiver-completed diary is common for children and for seizures with impaired awareness, because the person with the seizure may not know it happened; record who completed each entry.
Seizure counting rules add subtleties. Clusters (several seizures within a short time) may be counted as one episode or as individual seizures, depending on the protocol. Focal seizures with and without observable signs may be counted differently. Record the type, the number and, where your protocol needs it, the duration and whether rescue medication was used. These are structured fields in a repeating row per event or a daily table per day. Capture does not detect seizures from wearables or video, and no EEG or monitoring-device integration is claimed. Where a trial uses video-EEG monitoring in an epilepsy unit, enter the confirmed event counts and the monitoring dates from the report.
Developmental and epileptic encephalopathies
Rare syndromes such as Dravet syndrome and Lennox-Gastaut syndrome use syndrome-specific counts (for example convulsive seizures or drop seizures) with caregiver diaries, and often a global clinical impression from clinician and caregiver. The same diary and repeating-row structure applies; the seizure types that count come from the protocol. For small populations see EDC for rare disease trials, and for the wider neurology picture EDC for CNS and neurology trials.
Seizure diary day (demo, caregiver-completed)
Participant 003-0021 · Maintenance week 4 · Day 3
Any seizures today?
SZYNSeizure type
SZTYPENumber of seizures
SZNUMRescue medication given
RESCUEOpens the rescue medication row
Completed by
COMPBYProtocol to build
Epilepsy protocol elements and how they map to Capture
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Epilepsy history and eligibility | Seizure types, prior antiseizure medications, minimum baseline seizures | Screening form; medical history |
| Baseline stability | Dated doses of current antiseizure medication | Concomitant medications as repeating rows |
| Seizure diary | Daily yes/no, type, count, completed by | ePRO diary with reminders; seizure diary template |
| Titration and dose | Planned versus actual dose, reasons for change | Dose log with edit check on planned schedule |
| Rescue medication | Drug, dose, time, reason | Repeating row opened by skip logic from the diary |
| Drug levels (if collected) | Concentration, sample time | Lab results template |
| Suicidality and mood | Structured suicidal ideation and behaviour screening | C-SSRS layout; clinician-rated, licence in study documents |
| Adverse events | Dizziness, somnolence, rash, status epilepticus | Adverse event form |
| Global impression | Clinician and caregiver ratings | CGI layout |
Capture does not calculate seizure frequency or responder status. Compute them from the export under the statistical plan.
Build the diary and the baseline phase, then enter mock seizures
Create the daily diary, set reminders, enter a responder and a non-responder, and export the day-level data. Free sandbox, no credit card.
Safety and operations
Suicidality screening, medication changes and long extensions
Antiseizure medications carry a class warning for suicidal ideation, so most protocols screen at baseline and at scheduled visits. The Columbia Suicide Severity Rating Scale is the instrument usually named; it is clinician-rated, and Capture does not record its licence or supply its wording, so the licence stays with your study documents. Add an edit check that opens an action field when the answer to ideation or behaviour is positive, so the response is recorded. It is a data prompt that does not replace the clinical response in your protocol.
Medication changes are the hidden threat to an epilepsy dataset. A dose reduction or added drug during baseline may make a participant ineligible; a change during maintenance may be a protocol deviation. Date-order rules ensure that changes cannot fall before consent, and a deviation log makes them visible; see protocol deviation tracking software. Status epilepticus, hospitalisation and death, including suspected SUDEP, go through the SAE report form and the seriousness deadlines in your protocol.
Open-label extensions run for years, so participant retention matters. Keep the same participant ID, move to an extension epoch with its own visit forms and consider quarterly diary windows rather than continuous diaries if the protocol allows. For paediatric trials, the pediatric assent template and EDC for pediatric clinical trials cover parental permission and child assent. Blinded roles never receive treatment-arm values, so a blinded investigator reviewing diaries does not learn the arm. Data are hosted in the EU (Frankfurt) or the USA (N. Virginia).
Before first participant
Epilepsy study readiness checklist
Counting rules written
Clusters, seizure types and unknown seizures defined and shown as help text on the diary.
Missing day rule
Blank days stay missing; the statistical plan names the minimum valid days per period.
Baseline stability checked
Medication log and edit checks flag changes during baseline.
Caregiver route tested
A caregiver completes a mock diary on a phone; the completed-by field works.
C-SSRS action field
Positive answer opens an action record; licence filed with study documents.
Export reviewed
Day-level diary data opened in the statistics package; SDTM available if needed.
Does Capture calculate seizure frequency per 28 days?
No. Capture stores daily diary entries and valid-day information; the per-28-day rate and responder status are calculated from the export under your statistical plan.
Can caregivers complete the diary?
Yes. Diaries open from a secure link in a phone browser with reminders, and a completed-by field records who entered each day.
What if a day is missing?
It stays missing so the denominator of valid days is accurate. The minimum valid days per period is decided in your statistical plan.
Can I run baseline, titration and maintenance as separate phases?
Yes. Visits are defined per phase with visit windows, and forms can differ by phase. The study can continue into an extension epoch with the same participant ID.
Is there an EEG or wearable integration?
No integration is claimed. Enter confirmed event counts and monitoring dates from reports, or load them through your own data process.
Can I get SDTM datasets?
Yes. Capture exports CDISC SDTM as SAS XPT files with Define-XML, alongside CSV and Excel with an automatic data dictionary.
How much does it cost?
The sandbox is free with nearly every feature, no credit card. Plans and prices are on the pricing page.
Keep exploring
Related pages
EDC for CNS and neurology trials
The neurology overview.
Seizure diary template
Daily seizure log with reminders.
EDC for migraine trials
Another diary-count endpoint.
C-SSRS template
Suicidality screening layout.
Patient diary software
Reminders and completion tracking.
EDC for pediatric clinical trials
Parental permission and assent.
Pricing
Free sandbox.
Start your epilepsy study free
Free sandbox with nearly every feature. No credit card.