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Completed

NCT Number: NCT01407523

An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures

To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with Partial Onset Seizures after switching from the equivalent Levetiracetam oral dose.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Partial Onset Seizures

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1, Niigata, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is a male or female aged ≥ 16 years
  • Subject has Partial Onset Seizures that are classifiable according to the 1981 International League Against Epilepsy (ILAE) classification of Epileptic Seizures
  • Subject weighs ≥ 40 kg
  • Subject is currently taking Levetiracetam (LEV) as an adjunctive antiepileptic oral treatment with 1 to 3 other Antiepileptic Drugs (AEDs)

Exclusion criteria

  • Subject has problems with venous accessibility
  • Subject has participated in another clinical/pharmacological study during the last 4 weeks prior to the Screening Visit
  • Subject is pregnant or lactating
  • Subject has a history of suicide attempt(s) or presents with current depressive signs, current suicidal ideation, and/or behavior
  • Subject has clinically significant Electrocardiogram (ECG) abnormalities according to the investigator

Treatment and study plan

Levetiracetam

Drug
  • Formulation: concentrate for solution for infusion
  • Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
  • Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
  • Frequency: twice daily

Other names: Keppra®, E Keppra®

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)

    Time frame: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)

    An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  2. Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)

    Time frame: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)

    A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.

Secondary outcomes

  1. Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1

    Time frame: Day 1

    Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.

  2. Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4

    Time frame: Day 4

    Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.

  3. Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1

    Time frame: Day 1

    Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.

    Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:

    Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg.

  4. Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4

    Time frame: Day 4

    Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.

    Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:

    Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg.

  5. Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period

    Time frame: During the Evaluation Period (Day 1 to Day 4)

    Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Sponsors and collaborators

Lead sponsor

UCB Japan Co. Ltd.

Industry

Registry information

Official study title

An Open-label, Multicenter Study to Evaluate the Safety of Adjunctive Treatment With Intravenous Levetiracetam (L059 IV) in Epilepsy Patients Aged ≥ 16 Years With Partial Onset Seizures

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2011
Registry last updated
Mar 7, 2013

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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