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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 currently recruiting participants.
Verified April 2013 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01228747
First received: October 22, 2010
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Epilepsy
Generalized Tonic-Clonic Seizures
 Drug: Levetiracetam
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 276
Study Start Date: October 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo for 28 weeks
 Drug: Placebo
Matching oral placebo tablets twice daily for 28 weeks
Experimental: Levetiracetam
Levetiracetam treatment with flexible dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks
 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®

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228747

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

  Show 111 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01228747     History of Changes
Other Study ID Numbers: N01159
Study First Received: October 22, 2010
Last Updated: April 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
China: Food and Drug Administration

Keywords provided by UCB, Inc.:
Levetiracetam
epilepsy
generalized tonic-clonic

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013