Conversion to Monotherapy Study With Keppra XR for Partial Seizures

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Keppra XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419094

N01280

2007-000897-21 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Enrollment: 228 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects 12 to 75 years of age.
• Subjects must have inadequately controlled partial onset epilepsy.
• Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)

Exclusion criteria

• A history of status epilepticus in the 6 months preceding randomization.
• Significant medical, psychiatric or neurological illness.
• Intake of benzodiazepines on more than an occasional basis
• History of previous treatment with levetiracetam or sensitivity to levetiracetam.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 2 patient groups

Keppra XR 1000 mg/day

Experimental group

Description:

1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)

Treatment:

Drug: Keppra XR

Drug: Keppra XR

Keppra XR 2000 mg/day

Experimental group

Description:

2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)

Treatment:

Drug: Keppra XR

Drug: Keppra XR