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CompletedNCT00280696Updated Feb 11, 2015

A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

A Phase 3 interventional study of Levetiracetam 250 mg and Levetiracetam 500 mg in Epilepsies, Partial, sponsored by UCB Japan Co. Ltd.. Completed at 37 sites in Japan. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-02-11.

Sponsored by UCB Japan Co. Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study summary

A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.

02

Conditions studied

  • Epilepsies, Partial

Keywords

  • Epilepsies, Partial,
  • Keppra, levetiracetam
03

In context

Epilepsy

1,806 studies on the registry are indexed under Epilepsy; 418 are open to participants now.

This study's enrollment of 352 is above the median of 50 across 1,207 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Japan Co. Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:

  • Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation
  • Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit
  • Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months
  • Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks

Exclusion criteria

Exclusion Criteria:

The following patients are not eligible for inclusion into the study:

  • Subjects who were diagnosed with status epilepticus within 3 months before screening
  • Subjects with no partial seizures of which frequency was measured during the Baseline Period
  • Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study
  • Subjects with a history of oral treatment with Levetiracetam (LEV)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
352 participants (actual)

Study arms

  • Experimental
    Lev 0.5 g

    Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Drug: Levetiracetam 250 mg

  • Experimental
    Lev 1 g

    Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Drug: Levetiracetam 250 mg · Drug: Levetiracetam 500 mg

  • Experimental
    Lev 2 g

    Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Drug: Levetiracetam 250 mg · Drug: Levetiracetam 500 mg

  • Experimental
    Lev 3 g

    Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Drug: Levetiracetam 250 mg · Drug: Levetiracetam 500 mg

  • Placebo comparator
    Placebo

    Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Other: Placebo

Interventions

  • DrugLevetiracetam 250 mg

    * Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 250 mg * Route of Administration: Oral Use

    Also known as: Keppra

  • DrugLevetiracetam 500 mg

    * Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 500 mg * Route of Administration: Oral Use

    Also known as: Keppra

  • OtherPlacebo

    * Active Substance: Placebo * Pharmaceutical Form: Film-coated tablet * Concentration: 250 mg and 500 mg * Route of Administration: Oral Use

06

What researchers measure

Primary outcomes

  1. Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period

    Time frame: From Baseline to the 12-week Evaluation Period

Secondary outcomes

  1. Partial (Type I) seizure frequency per week over the Evaluation Period

    Time frame: 12-week Evaluation Period

  2. Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period

    Time frame: From Baseline to the 12-week Evaluation Period

  3. Seizure freedom over the Evaluation Period

    Time frame: 12-week Evaluation Period

  4. Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period

    Time frame: From Baseline to the 12-week Evaluation Period

  5. Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period

    Time frame: From Baseline to the 12-week Evaluation Period

07

Study locations

37 sites
  • Aichi-gun, Aichi, Japan
  • Nagoya, Aichi, Japan
  • Nayoga, Aichi, Japan
  • Hirosaki, Aomori, Japan
  • Kitakyusyu, Fukuoka, Japan
  • Kurume, Fukuoka, Japan
  • Fukuyama, Hiroshima, Japan
  • Asahikawa, Hokkaido, Japan
  • Hakodate, Hokkaido, Japan
  • Sapporo, Hokkaido, Japan
  • Kobe, Hyogo, Japan
  • Kahoku-gun, Ishikawa, Japan
  • Kikuchi-gun, Kumamoto, Japan
  • Sendai, Miyagi, Japan
  • Omura, Nagasaki, Japan
  • Izumi, Osaka, Japan
  • Neyagawa, Osaka, Japan
  • Suita, Osaka, Japan
  • Kawachi-gun, Tochigi, Japan
  • Kodaira, Tokyo, Japan
  • Ube, Yamaguchi, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Gihu, Japan
  • Hiroshima, Japan
  • Kagoshima, Japan
  • Kobe, Japan
  • Kyoto, Japan
  • Miyazaki, Japan
  • Nagaoka, Japan
  • Niigata, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Shizuoka, Japan
  • Tokyo, Japan
  • Toyama, Japan
  • Yamagata, Japan
08

References and documents

Publications

  • Inoue Y, Yagi K, Ikeda A, Sasagawa M, Ishida S, Suzuki A, Yoshida K; Japan Levetiracetam N01221 Study Group. Efficacy and tolerability of levetiracetam as adjunctive therapy in Japanese patients with uncontrolled partial-onset seizures. Psychiatry Clin Neurosci. 2015 Oct;69(10):640-8. doi: 10.1111/pcn.12300. Epub 2015 May 13. PubMed 25854635 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00280696
Lead sponsor
UCB Japan Co. Ltd.
Responsible party
Sponsor
First posted
Jan 23, 2006
Start date
Nov 2005
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Feb 11, 2015

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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