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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01228747
First received: October 22, 2010
Last updated: May 29, 2015
Last verified: May 2015

October 22, 2010
May 29, 2015
October 2010
April 2014   (final data collection date for primary outcome measure)
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) [ Time Frame: From Baseline to Week 28 ] [ Designated as safety issue: No ]

Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation:

Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.

Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline

Percentage reduction from the Combined Baseline (a 4-week Retrospective Baseline + 4-week Prospective Baseline) in the generalized tonic-clonic seizure frequency per week over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods) [ Time Frame: Baseline, 28 weeks ] [ Designated as safety issue: No ]
Percentage reduction from the Combined Baseline (a 4-week Retrospective Baseline + 4-week Prospective Baseline) in the generalized tonic-clonic seizure frequency per week over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)
Complete list of historical versions of study NCT01228747 on ClinicalTrials.gov Archive Site
  • The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period [ Time Frame: From Baseline to Evaluation Period (Week 12 to Week 28) ] [ Designated as safety issue: No ]

    Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation:

    Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.

    Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline.

  • 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 [ Time Frame: From Baseline to Week 28 ] [ Designated as safety issue: No ]

    A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.

    Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline

  • 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 [ Time Frame: From Baseline to Evaluation Period (Week 12 to Week 28) ] [ Designated as safety issue: No ]

    A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.

    Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline

  • Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period [ Time Frame: Evaluation Period (Week 12 to Week 28) ] [ Designated as safety issue: No ]
    A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.
  • The percentage reduction in generalized tonic-clonic seizure frequency per week from the combined baseline over the evaluation period [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
    The percentage reduction in generalized tonic-clonic seizure frequency per week from the combined baseline over the evaluation period
  • 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 [ Time Frame: Baseline, 28 weeks ] [ Designated as safety issue: No ]
    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
  • 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 [ Time Frame: Baseline,16 weeks ] [ Designated as safety issue: No ]
    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
  • Generalized tonic-clonic seizure freedom over the evaluation period [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Generalized tonic-clonic seizure freedom over the evaluation period
Not Provided
Not Provided
 
A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Epilepsy
  • Generalized Tonic-Clonic Seizures
  • Drug: Levetiracetam
    Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
    Other Name: Keppra®
  • Drug: Placebo
    Matching oral placebo tablets twice daily for 28 weeks
  • Placebo Comparator: Placebo
    Matching placebo for 28 weeks
    Intervention: Drug: Placebo
  • Experimental: Levetiracetam
    Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
    Intervention: Drug: Levetiracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
361
May 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Japan
 
NCT01228747
N01159, 2014-004401-32
No
UCB Pharma ( UCB Japan Co. Ltd. )
UCB Japan Co. Ltd.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP