A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

• ClinicalTrials.gov Identifier: NCT01292837
• Recruitment Status: Completed
• First Posted: February 10, 2011
• Results First Posted: August 12, 2014
• Last Update Posted: May 15, 2015
• Sponsor: UCB Japan Co. Ltd.
• Information provided by (Responsible Party): UCB Pharma ( UCB Japan Co. Ltd. )

Study Description

Brief Summary:

To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).

Condition or disease	Intervention/treatment	Phase
Epilepsy; Generalized Tonic-clonic Seizures	Drug: Levetiracetam	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Antiepileptic Drug(s)
• Study Start Date: February 2011
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Levetiracetam; Twice daily (morning and evening) orally	Drug: Levetiracetam; The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.; Other Names: Keppra; E Keppra

Outcome Measures

Primary Outcome Measures :

1. The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods) [ Time Frame: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) ]

   The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.

   The percent change from Baseline = (B - T)/B x 100

   The seizure frequency per week was calculated using the following formula:

   Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7

Secondary Outcome Measures :

1. The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period [ Time Frame: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) ]

   The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.

   The percent change from Baseline = (B - E)/B x 100

   The seizure frequency per week was calculated using the following formula:

   Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7

2. Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period [ Time Frame: From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) ]
   The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.
3. Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period [ Time Frame: From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) ]
   The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.
4. Generalized Tonic-clonic Seizure Freedom Over the Treatment Period [ Time Frame: Treatment Period (Week 0 to Week 24) ]
   A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.
5. Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period [ Time Frame: Evaluation Period (Week 4 to Week 24) ]
   A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
• A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period

Exclusion Criteria:

• Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
• Diagnosis of Lennox-Gastaut Syndrome
• Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
• A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1

Contacts and Locations

Locations

Japan

191

Akita, Japan

184

Bunkyo, Japan

309

Bunkyo, Japan

107

Gifu, Japan

303

Hiroshima, Japan

108

Kobe, Japan

302

Kodaira, Japan

306

Koshi, Japan

136

Moriyama, Japan

305

Nagoya, Japan

190

Nerima, Japan

125

Neyagawa, Japan

301

Niigata, Japan

116

Ohmura, Japan

109

Okayama, Japan

308

Onojo, Japan

119

Saitama, Japan

117

Sapporo, Japan

304

Sapporo, Japan

103

Sendai, Japan

138

Shimotsuke, Japan

307

Shizuoka, Japan

139

Takatsuki, Japan

135

Tsu, Japan

193

Yokohama, Japan

310

Yufu, 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: NCT01292837
• Other Study ID Numbers: N01363; 2014-004382-25 ( EudraCT Number )
• First Posted: February 10, 2011
• Results First Posted: August 12, 2014
• Last Update Posted: May 15, 2015
• Last Verified: April 2015

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

Levetiracetam; Epilepsy; Generalized tonic-clonic seizures

Additional relevant MeSH terms:

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