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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01228747
First received: October 22, 2010
Last updated: April 8, 2014
Last verified: April 2014

October 22, 2010
April 8, 2014
October 2010
April 2014   (final data collection date for primary outcome measure)
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: From Basline to Week 28 ] [ 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)
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 reduction in generalized tonic-clonic seizure frequency per week from the combined baseline over the evaluation period [ Time Frame: From Baseline to Evaluation Period (Week 16 to Week 28) ] [ 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: From Baseline to Week 28 ] [ 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: From Baseline to Evaluation Period (Week 16 to Week 28) ] [ 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: Evaluation Period (Week 16 to Week 28) ] [ Designated as safety issue: No ]
    Generalized tonic-clonic seizure freedom over 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 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.
 
Active, not recruiting
276
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
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
April 2014

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