AzTrials
AzTrials

Epilepsies, PartialPhase 3NCT00280696

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

A Phase 3 study testing Levetiracetam 250 mg and Levetiracetam 500 mg in people with Epilepsies, Partial, run by UCB Japan Co. Ltd. at 37 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Epilepsies, Partial
What is being tested?
Levetiracetam 250 mg and Levetiracetam 500 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
352 participants
Where
37 sitesJapan
Study dates
Nov 2005to Nov 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Japan37 sites

  • Study site

    Aichi-gun, Aichi-ken

  • Study site

    Asahikawa, Hokkaido

  • Study site

    Chiba, Chiba

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Fukuyama, Hiroshima

  • Study site

    Gifu, Gihu

  • Study site

    Hakodate, Hokkaido

  • Study site

    Hirosaki, Aomori

  • Study site

    Hiroshima, Hiroshima

  • Study site

    Izumi, Osaka

  • Study site

    Kagoshima, Kagoshima-ken

  • Study site

    Kahoku-gun, Ishikawa-ken

  • Study site

    Kawachi-gun, Tochigi

  • Study site

    Kikuchi-gun, Kumamoto

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kobe

  • Study site

    Kodaira, Tokyo

  • Study site

    Kurume, Fukuoka

  • Study site

    Kyoto, Kyoto

  • Study site

    Miyazaki, Miyazaki

  • Study site

    Nagaoka, Nagaoka

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nayoga, Aichi-ken

  • Study site

    Neyagawa, Osaka

  • Study site

    Niigata, Niigata

  • Study site

    Okayama, Okayama-ken

  • Study site

    Ōmura, Nagasaki

  • Study site

    Osaka, Osaka

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sendai, Miyagi

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Suita, Osaka

  • Study site

    Tokyo, Tokyo

  • Study site

    Toyama, Toyama

  • Study site

    Ube, Yamaguchi

  • Study site

    Yamagata, Yamagata

Other trials in Japan

About this study

Official title: A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)

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.

Being tested
Levetiracetam 250 mg, Levetiracetam 500 mg, Placebo
Keywords
Epilepsies, Partial,, Keppra, levetiracetam
Medical subject headings
Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levetiracetam 250 mgDrug

    Also called Keppra

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

  • Levetiracetam 500 mgDrug

    Also called Keppra

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

  • PlaceboOther

    • Active Substance: Placebo
    • Pharmaceutical Form: Film-coated tablet
    • Concentration: 250 mg and 500 mg
    • Route of Administration: Oral Use
Study groups in NCT00280696
Study groupRoleWhat they receive
Lev 0.5 gExperimentalLevetiracetam 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).
Receives: Drug: Levetiracetam 250 mg
Lev 1 gExperimentalLevetiracetam 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).
Receives: Drug: Levetiracetam 250 mg; Drug: Levetiracetam 500 mg
Lev 2 gExperimentalLevetiracetam 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).
Receives: Drug: Levetiracetam 250 mg; Drug: Levetiracetam 500 mg
Lev 3 gExperimentalLevetiracetam 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).
Receives: Drug: Levetiracetam 250 mg; Drug: Levetiracetam 500 mg
PlaceboPlacebo comparatorPlacebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From Baseline to the 12-week Evaluation Period

Secondary outcomes (5)

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

    Measured: 12-week Evaluation Period

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

    Measured: From Baseline to the 12-week Evaluation Period

  3. Seizure freedom over the Evaluation Period

    Measured: 12-week Evaluation Period

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

    Measured: 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

    Measured: From Baseline to the 12-week Evaluation Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00280696
Sponsor's protocol ID
N01221
Other IDs
2014-004333-57, 2014
Status last verified
Feb 2015
First submitted
19 Jan 2006
Last updated
11 Feb 2015
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levetiracetam 250 mg and Levetiracetam 500 mg in people with Epilepsies, Partial, run by UCB Japan Co. Ltd. at 37 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00280696, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in