An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures - Full Text View

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT01063764

Purpose

Objective of the First Period: To evaluate the efficacy of levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Condition	Intervention	Phase
Epilepsy Partial Seizures	Drug: Levetiracetam	Phase III

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, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Percentage reduction from baseline in partial seizure frequency per week over the 14-week treatment period (up-titration + evaluation periods) [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The percentage reduction in partial seizure frequency per week from baseline over the evaluation period [ Time Frame: Baseline, 4 weeks to 14 weeks period ] [ Designated as safety issue: No ]
Partial seizure frequency per week from baseline over the treatment period [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
Partial seizure frequency per week from baseline over the evaluation period [ Time Frame: Baseline, 4 weeks to 14 weeks period ] [ Designated as safety issue: No ]
Partial seizures 50% responder rate (the proportion of subjects with 50% or more reduction from baseline in the frequency of partial epileptic seizures) during the treatment period [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
Partial seizures 50% responder rate (the proportion of subjects with 50% or more reduction from baseline in the frequency of partial epileptic seizures) during the evaluation period [ Time Frame: Baseline, 4 weeks to 14 weeks period ] [ Designated as safety issue: No ]
Seizure freedom over the treatment period [ Time Frame: Baseline, 14 weeks ] [ Designated as safety issue: No ]
Seizure freedom over the evaluation period [ Time Frame: Baseline, 4 weeks to 14 weeks period ] [ Designated as safety issue: No ]
The percentage reduction from baseline in partial seizure frequency per week by 3-month window over the evaluation period in the second period (excluding withdrawal period) [ Time Frame: Baseline, by 3-month window in the second period ] [ Designated as safety issue: No ]

Enrollment:	73
Study Start Date:	January 2010
Estimated Study Completion Date:	November 2013
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Levetiracetam Open-label, single-arm	Drug: Levetiracetam First period: Dry syrup 50%, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration PO (per os) for 14 weeks. Second period: Dry syrup 50% or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration PO (per os) until indication granted Other Name: Keppra

Detailed Description:

Objectives of the Second Period: To provide the levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the first period of this study.

Eligibility

Ages Eligible for Study:	4 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient has partial epilepsy and the diagnosis must be confirmed in the last 6 months
The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to baseline and must have at least 8 partial seizures during the 8-week prospective baseline period
Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Exclusion Criteria:

The patient has a treatable seizure etiology
The patient has epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
The patient has a history of status epilepticus during the 3 months prior to visit 1
The patient has a past and present history of pseudo seizures
The patient has a current diagnosis of Lennox-Gastaut syndrome

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063764

Locations

Japan

Chuo, Japan

Hakodate, Japan

Hamamatsu, Japan

Hiroshima, Japan

Izumi, Japan

Kobe, Japan

Kodaira, Japan

Koga, Japan

Koushi, Japan

Kurume, Japan

Kyoto, Japan

Nagaoka, Japan

Nagoya, Japan

Neyagawa, Japan

Niigata, Japan

Okayama, Japan

Osaka, Japan

Sagamihara, Japan

Sapporo, Japan

Sendai, Japan

Shizuoka, Japan

Suita, Japan

Takatsuki, Japan

Tokyo, Japan

Yachiyo, Japan

Yamagata, Japan

Yokohama, Japan

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT01063764 History of Changes
Other Study ID Numbers:	N01223
Study First Received:	February 1, 2010
Last Updated:	August 19, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB, Inc.:

Keppra
Levetiracetam
children
epilepsy
partial seizures

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Anticonvulsants

Piracetam
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012