NCT01292837

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 12, 2014

Completed
Last Updated

May 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

February 8, 2011

Results QC Date

June 3, 2014

Last Update Submit

April 27, 2015

Conditions

EpilepsyGeneralized Tonic-clonic Seizures

Keywords

LevetiracetamEpilepsyGeneralized tonic-clonic seizures

Outcome Measures

Primary Outcomes (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)

    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)

Secondary Outcomes (5)

  • The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period

    From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)

  • 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

    From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)

  • Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period

    From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)

  • Generalized Tonic-clonic Seizure Freedom Over the Treatment Period

    Treatment Period (Week 0 to Week 24)

  • Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period

    Evaluation Period (Week 4 to Week 24)

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Twice daily (morning and evening) orally

Drug: Levetiracetam

Interventions

LevetiracetamDRUG

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.

Also known as: Keppra, E Keppra
Levetiracetam

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

191

Akita, Japan

Location

184

Bunkyō City, Japan

Location

309

Bunkyō City, Japan

Location

107

Gifu, Japan

Location

303

Hiroshima, Japan

Location

108

Kobe, Japan

Location

302

Kodaira, Japan

Location

306

Kōshi, Japan

Location

136

Moriyama, Japan

Location

305

Nagoya, Japan

Location

190

Nerima City, Japan

Location

125

Neyagawa, Japan

Location

301

Niigata, Japan

Location

116

Ohmura, Japan

Location

109

Okayama, Japan

Location

308

Ōnojō, Japan

Location

119

Saitama, Japan

Location

117

Sapporo, Japan

Location

304

Sapporo, Japan

Location

103

Sendai, Japan

Location

138

Shimotsuke, Japan

Location

307

Shizuoka, Japan

Location

139

Takatsuki, Japan

Location

135

Tsu, Japan

Location

193

Yokohama, Japan

Location

310

Yufu, Japan

Location

Related Links

MeSH Terms

Conditions

EpilepsySeizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB
++1 877 822 9493

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 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 10, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 15, 2015

Results First Posted

August 12, 2014

Record last verified: 2015-04

Locations

JP(26)