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NCT Number: NCT07588971

Natural History and Prognosis of Pediatric Epilepsies With Different Etiology

Epilepsy is one of the most common neurological diseases in Italy, affecting about 500,000 people. Pediatric age represents one of the most affected groups with a consequent significant impact on the quality of life of the families involved.

The study aims to monitor the cognitive functions of patients followed at our center in order to determine the main types of pathways and highlight their determinants. The ultimate goal is to define what are the main clinical and instrumental predictors of cognitive function and its variation over time.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

domenica Immacolata Battaglia, MD

CONTACT

[email protected]

+39 0630159222

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients seen at the Children's Neuropsychiatry of the Fondazione Policlinico Gemelli IRCCS (UOS Diagnosis and Treatment of Drug-Resistant Epilepsies, Day Hospital or inpatient setting at the Department of Children's Neuropsychiatry) with onset of first seizure between the ages of 0 and 18 years and subsequent diagnostic confirmation of epilepsy (2 or more unprovoked seizures at least 24 hours apart or definite epilepsy syndrome, with diagnostic confirmation by the child neuropsychiatrist).
  • Patients already followed at Child Neuropsychiatry with a diagnosis of epilepsy with age of onset between 0 and 18 years.
  • Patients referred to our Center during follow-up with a diagnosis of epilepsy with age of onset between 0 and 18 years.

Exclusion criteria

  • Patients with unconfirmed diagnosis of epilepsy after the first critical episode.
  • Patients from other Centers, for whom the history, clinical and instrumental data are not sufficiently detailed and in accordance with the methodologies followed at our Center.
  • Patients with follow-up < 2 years.
  • Patients for whom study consent is not provided.

Treatment and study plan

Primary outcomes

  1. neurodevelopment level

    Time frame: 12 months after entry visit

    Evaluate prescholar global development and scholar cognitive level with Griffiths or Weschler scales where applicable according to age.

Secondary outcomes

  1. Seizure outcome

    Time frame: 24 months after entry visit

    Evaluate the reduction in seizures (percentage)

  2. QOLIE-31

    Time frame: 24 months after entry visit

    Evaluate the Impact of the Epilepsy on the quality of life

  3. Clinical Global Impression Scale

    Time frame: 24 months after entry visit

    Evaluate the global clinical impression to have a measure of epilepsy severity and the burden of antiseizure medication on daily life.

Study contacts

Contact information is provided by the study sponsor or research team.

Domenica Immacolata Battaglia, MD

CONTACT

[email protected]

+39 0630159222

Michela Quintiliani, MD

CONTACT

[email protected]

+39 0630159222

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Natural History and Prognosis of Pediatric Epilepsies With Different Etiology: Long-term Study

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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