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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407523
• Other study ID #: N01378
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2011
• Last updated: January 30, 2013
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Partial Onset Seizures
• Seizures

Intervention

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

Locations

Country	Name	City	State
Japan	3	Kodaira-city	Tokyo
Japan	1	Niigata-city	Niigata
Japan	2	Shizuoka-city	Shizuoka
Japan	4	Yamagata-city, Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
UCB Japan Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)	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.	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)	No
Primary	Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)	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.	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)	No
Secondary	Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on 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.	Day 1	No
Secondary	Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on 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.	Day 4	No
Secondary	Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on 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.	Day 1	No
Secondary	Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on 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.	Day 4	No
Secondary	Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period	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.	During the Evaluation Period (Day 1 to Day 4)	No

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