Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Keppra XR (Levetiracetam XR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419393

2007-000899-17 (EudraCT Number)

N01281

Details and patient eligibility

About

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.

Enrollment: 190 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period

Exclusion criteria

• Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]
• Subjects who were discontinued prior to the end of titration period

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 1 patient group

Keppra XR (Levetiracetam XR)

Experimental group

Description:

1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)

Treatment:

Drug: Keppra XR (Levetiracetam XR)