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

NCT01407523 | Completed Phase 2 Results

• 1 other identifier: N01378
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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.

Conditions

Epilepsy; Partial Onset Seizures

Keywords

Levetiracetam; Infusion; Epilepsy; Partial Onset Seizures

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (5)

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

  Day 1

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

  Day 4

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

  Day 1

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

  Day 4

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

  During the Evaluation Period (Day 1 to Day 4)

Study Arms (1)

Levetiracetam

EXPERIMENTAL

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

Drug: Levetiracetam

Interventions

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

Also known as: Keppra®, E Keppra®

Levetiracetam

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Japan Co. Ltd.: lead

Study Sites (4)

1

Niigata, Niigata, Japan

Location

2

Shizuoka, Shizuoka, Japan

Location

3

Kodaira, Tokyo, Japan

Location

4

Yamagata-city, Yamagata, Japan

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493 (UCB)

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 2, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 7, 2013
• Results First Posted: March 7, 2013

Record last verified: 2013-01

Locations

JP (4)