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

• 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: UCB Japan Co. Ltd.
• Information provided by (Responsible Party): UCB Pharma ( UCB Japan Co. Ltd. )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Epilepsy; Partial Onset Seizures	Drug: Levetiracetam	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: July 2011
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Japan Co. Ltd.
• ClinicalTrials.gov Identifier: NCT01407523
• Other Study ID Numbers: N01378
• First Posted: August 2, 2011
• Results First Posted: March 7, 2013
• Last Update Posted: March 7, 2013
• Last Verified: January 2013

Keywords provided by UCB Pharma ( UCB Japan Co. Ltd. ):

Levetiracetam; Infusion; Epilepsy; Partial Onset Seizures

Additional relevant MeSH terms:

Epilepsy; Seizures; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Levetiracetam; Anticonvulsants; Nootropic Agents