An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures
This study has been completed.
Sponsor:
UCB Japan Co. Ltd.
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
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
Other Names:
|
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
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 May 19, 2013