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

Epilepsy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292837
• Other study ID #: N01363
• Secondary ID: 2014-004382-25
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2011
• Last updated: April 27, 2015
• Start date: February 2011
• Est. completion date: June 2013

Study information

• Verified date: April 2015
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Epilepsy
• Generalized Tonic-clonic Seizures
• Seizures

Intervention

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.

Locations

Country	Name	City	State
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

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	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)	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	From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)	No
Secondary	The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period	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	From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)	No
Secondary	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	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.	From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)	No
Secondary	Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period	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.	From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)	No
Secondary	Generalized Tonic-clonic Seizure Freedom Over the Treatment Period	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.	Treatment Period (Week 0 to Week 24)	No
Secondary	Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period	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.	Evaluation Period (Week 4 to Week 24)	No

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