UnknownNot Applicable

Longitudinal Early Epilepsy Study

Netherlands60 participantsStarted 2016-09

Plain-language summary

This longitudinal study will focus on the cognitive and brain development of children with absence epilepsy. In addition, the investigators aim to identify prognostic factors for cognitive deterioration and/or poor seizure control in these children.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Primarily presented with daily occurring episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years.
. An EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG(58).
. Early absence epilepsy , defined as a confirmed diagnosis or seizures within 2 years.
. Aged 6-12 years
. Permitted accompanying factors:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of multimodal MRI parameters on brain connectivity

Timeframe: Baseline; first year; second year

Change of cognition measured by a battery of neuropsychological tests

Timeframe: Baseline; first year; second year

Time in months since start of medication till seizure control is attained, as assessed by anamnesis and a confirmatory routine-EEG.

Timeframe: Within 2 years

Trial details

NCT IDNCT02954107

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-09

Contact for this trial

Eric LA Fonseca Wald, MD

+31 (0)43 387 65 84 LEES.studie.kinderneurologie@mumc.nl

View on ClinicalTrials.gov More Absence Epilepsy trials

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Primarily presented with daily occurring episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years.
. An EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG(58).
. Early absence epilepsy , defined as a confirmed diagnosis or seizures within 2 years.
. Aged 6-12 years
. Permitted accompanying factors:

What they're measuring

Change of multimodal MRI parameters on brain connectivity

Timeframe: Baseline; first year; second year

Change of cognition measured by a battery of neuropsychological tests

Timeframe: Baseline; first year; second year

Time in months since start of medication till seizure control is attained, as assessed by anamnesis and a confirmatory routine-EEG.

Timeframe: Within 2 years