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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01407523
First received: July 29, 2011
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Epilepsy
Partial Onset Seizures
Drug: Levetiracetam
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.

  • Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.

  • Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

    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.


  • Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

    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.


  • Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period [ Time Frame: During the Evaluation Period (Day 1 to Day 4) ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
Drug: Levetiracetam
  • 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®

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407523

Locations
Japan
1
Niigata-city, Niigata, Japan
2
Shizuoka-city, Shizuoka, Japan
3
Kodaira-city, Tokyo, Japan
4
Yamagata-city, Yamagata, Japan
Sponsors and Collaborators
UCB Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc. ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01407523     History of Changes
Other Study ID Numbers: N01378
Study First Received: July 29, 2011
Results First Received: January 30, 2013
Last Updated: January 30, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB, Inc.:
Levetiracetam
Infusion
Epilepsy
Partial Onset Seizures

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 August 26, 2014