Phase 3 N=251 Randomized Triple-blind Treatment

A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

Epilepsy · Generalized Tonic-Clonic Seizures

Bottom Line

View on ClinicalTrials.gov: NCT01228747 ↗

Enrolled (actual)

251

Serious AEs

2.0%

Results posted

May 2015

Primary outcome: Primary: Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods) — -13.19; -68.22 Percentage Change — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Levetiracetam (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: UCB Japan Co. Ltd.
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)	-13.19; -68.22	<0.0001 sig
SECONDARY The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period	-4.44; -68.27	—
SECONDARY Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period	31; 91	—
SECONDARY Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period	33; 82	—
SECONDARY Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period	3; 32	—

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.

Eligibility Criteria

Inclusion Criteria

An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE classification of epileptic seizures (Epilepsia, 1981)
A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the combined baseline period

Exclusion Criteria

Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
Diagnosis of Lennox-Gastaut Syndrome
Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imagining features
A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1

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Data sourced from ClinicalTrials.gov (NCT01228747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.