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

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ClinicalTrials.gov Identifier: NCT01407523
Recruitment Status : Completed
First Posted : August 2, 2011
Results First Posted : March 7, 2013
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsy
Partial Onset Seizures
Intervention Drug: Levetiracetam
Enrollment 16
Recruitment Details

This study started to enroll subjects in July 2011 in order to end up with 4 centers in Japan.

16 subjects were treated and completed the study. All 16 subjects are included in the Safety Set.

Pre-assignment Details The Safety Set (SS) consisted of all subjects who started Levetiracetam intravenous (LEV IV) infusion after they had signed and dated the Informed Consent form. Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
Arm/Group Title Levetiracetam
Hide Arm/Group Description

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Levetiracetam
Hide Arm/Group Description

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
32.9  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 16 participants
16
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 16 participants
68.82  (12.38)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 16 participants
163.40  (8.95)
1.Primary Outcome
Title Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS)
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
5
2.Primary Outcome
Title Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SS)
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
Hide Description Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (µg/mL)
11.732
(63.1%)
4.Secondary Outcome
Title Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
Hide Description Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (µg/mL)
11.632
(59.6%)
5.Secondary Outcome
Title Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1
Hide Description

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.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (µg/mL)
6.611
(29.6%)
6.Secondary Outcome
Title Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4
Hide Description

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.

Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (µg/mL)
5.492
(29.4%)
7.Secondary Outcome
Title Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period
Hide Description 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.
Time Frame During the Evaluation Period (Day 1 to Day 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). The FAS consisted of all subjects in the Safety Set (SS) with evaluable seizure frequency data over the Evaluation Period. All 16 subjects in the SS are included in the FAS.
Arm/Group Title Levetiracetam
Hide Arm/Group Description:

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
Overall Number of Participants Analyzed 16
Median (Inter-Quartile Range)
Unit of Measure: Seizures per day
0.38
(0.00 to 1.00)
Time Frame Adverse Events (AEs) were collected over the entire Study Period from Screening (1 to 14 days prior to the first intravenous infusion) over Evaluation Period (4 days) to the end of Follow-Up Period (1 to 14 days after the final intravenous infusion).
Adverse Event Reporting Description AEs refer to Safety Set (SS). The Safety Set (SS) consisted of all subjects who started Levetiracetam intravenous (LEV IV) infusion after they had signed and dated the Informed Consent form.
 
Arm/Group Title Levetiracetam
Hide Arm/Group Description

Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.

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
All-Cause Mortality
Levetiracetam
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levetiracetam
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levetiracetam
Affected / at Risk (%) # Events
Total   5/16 (31.25%)    
Gastrointestinal disorders   
Gingivitis * 1  1/16 (6.25%)  1
Toothache * 1  1/16 (6.25%)  1
General disorders   
Injection site inflammation * 1  1/16 (6.25%)  1
Injection site pain * 1  1/16 (6.25%)  1
Injection site swelling * 1  1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Contusion * 1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01407523     History of Changes
Other Study ID Numbers: N01378
First Submitted: July 29, 2011
First Posted: August 2, 2011
Results First Submitted: January 30, 2013
Results First Posted: March 7, 2013
Last Update Posted: March 7, 2013