Named Patient Program with Levetiracetam Oral Solution, for Pediatric Patients suffering from Epilepsy having previously participated in study N01148 - ND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005078-55-IT

Enrollment

Registered

2007-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy MedDRA version: 6.1 Level: PT Classification code 10040703

Interventions

Trade Name: Keppra Pharmaceutical Form: Oral solution INN or Proposed INN: Levetiracetam Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - previous participation to the N01148 trial - consent signature by subjects parents Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: To continue to supply levetiracetam in an open label way to pediatric patients suffering from epilepsy who previously participated in the open-label, long-term study N01148.;Secondary Objective: Pharmacovigilance;Primary end point(s): Not applicable: only safety data will be collected	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026