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Completed

NCT Number: NCT01398956

An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Generalized Tonic-clonic Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

152, Fujisawa, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
  • The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators

Exclusion criteria

  • Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible

Treatment and study plan

Levetiracetam

Drug

formulation: tablet or dry syrup

strength: 250 mg tablet, 500 mg tablet, dry syrup 50%

dosage: Sb ≥16 years and ≥4 and <16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and <16 years (<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day

frequency: twice daily

Other names: Keppra, E Keppra

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events During the Entire Study Period

    Time frame: Through study completion, an average of 3 years

Secondary outcomes

  1. The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).

    Time frame: During the Treatment Period (up to 4.8 years)

    Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies 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 Treatment Period.

  2. The Incidence of Adverse Drug Reactions During the Entire Study Period

    Time frame: Through study completion, an average of 3 years

    Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2011
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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