Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

UCB

Status and phase: Completed; Phase 3

Conditions: Generalized Epilepsy

Treatments: Drug: Levetiracetam 250 mg; Drug: Levetiracetam 500 mg; Drug: Levetiracetam 166 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150748

N167

2004-001997-13 (EudraCT Number)

Details and patient eligibility

About

An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

Enrollment: 217 patients

Sex: All

Ages: 4 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
• Subjects who were/are suffering from primary generalized (type II) epileptic seizures
• Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected

Exclusion criteria

• Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol
• Concomitant use of any drug with possible central nervous system effects unless at a stable dose
• Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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217 participants in 1 patient group

Levetiracetam

Experimental group

Description:

Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

Treatment:

Drug: Levetiracetam 250 mg

Drug: Levetiracetam 500 mg

Drug: Levetiracetam 166 mg