NCT01398956

Brief Summary

The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_3

Geographic Reach
1 country

32 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

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 9, 2017

Completed
Last Updated

August 15, 2017

Status Verified

July 1, 2017

Enrollment Period

4.8 years

First QC Date

July 13, 2011

Results QC Date

September 29, 2016

Last Update Submit

July 6, 2017

Conditions

EpilepsyGeneralized Tonic-clonic Seizures

Keywords

LevetiracetamEpilepsyGeneralized tonic-clonic seizures

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment Emergent Adverse Events During the Entire Study Period

    Through study completion, an average of 3 years

Secondary Outcomes (2)

  • The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).

    During the Treatment Period (up to 4.8 years)

  • The Incidence of Adverse Drug Reactions During the Entire Study Period

    Through study completion, an average of 3 years

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Twice daily (morning and evening) orally

Drug: Levetiracetam

Interventions

LevetiracetamDRUG

formulation: tablet or dry syrup strength: 250 mg tablet, 500 mg tablet, dry syrup 50% dosage: Sb ≥16 years and ≥4 and \<16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and \<16 years (\<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day frequency: twice daily

Also known as: Keppra, E Keppra
Levetiracetam

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
  • The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators

You may not qualify if:

  • Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

152

Fujisawa, Japan

Location

112

Fukuoka, Japan

Location

113

Fukuoka, Japan

Location

165

Fukuoka, Japan

Location

166

Fukuoka, Japan

Location

187

Fukushima, Japan

Location

107

Gifu, Japan

Location

162

Himeji, Japan

Location

110

Hiroshima, Japan

Location

117

Hokkaido, Japan

Location

130

Hokkaido, Japan

Location

176

Hokkaido, Japan

Location

143

Kagoshima, Japan

Location

156

Kagoshima, Japan

Location

120

Kodaira, Japan

Location

105

Kokubunji, Japan

Location

306

Kōshi, Japan

Location

172

Miyazaki, Japan

Location

179

Miyazaki, Japan

Location

305

Nagoya, Japan

Location

106

Niigata, Japan

Location

153

Niigata, Japan

Location

109

Okayama, Japan

Location

174

Osaka, Japan

Location

119

Saitama, Japan

Location

147

Sakai, Japan

Location

194

Sakai, Japan

Location

304

Sapporo, Japan

Location

138

Tochigi, Japan

Location

184

Tokyo, Japan

Location

190

Tokyo, Japan

Location

111

Ube, 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 (Study Director)
Organization
UCB Cares
+1887822

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

July 13, 2011

First Posted

July 21, 2011

Study Start

June 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 15, 2017

Results First Posted

March 9, 2017

Record last verified: 2017-07

Locations

JP(32)