AzTrials
AzTrials

EpilepsyPhase 3NCT00419094

Conversion to Monotherapy Study With Keppra XR for Partial Seizures

A Phase 3 study testing Keppra XR in people with Epilepsy, run by UCB Pharma at 45 sites in 4 countries.

Completed

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

Official record
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Trial summary

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Epilepsy
What is being tested?
Keppra XR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
45 sitesin 4 countries
Study dates
Aug 2007to Sep 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female subjects 12 to 75 years of age.
  • Subjects must have inadequately controlled partial onset epilepsy.
  • Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)

Who cannot join

  • A history of status epilepticus in the 6 months preceding randomization.
  • Significant medical, psychiatric or neurological illness.
  • Intake of benzodiazepines on more than an occasional basis
  • History of previous treatment with levetiracetam or sensitivity to levetiracetam.

Trial locations and contacts

45 sites in 4 countries.

45 sites in 4 countries

United States24 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Bakersfield, California

  • Study site

    Beaufort, South Carolina

  • Study site

    Bend, Oregon

  • Study site

    Bethesda, Maryland

  • Study site

    Buffalo, New York

  • Study site

    Camden, New Jersey

  • Study site

    Cedarhurst, New York

  • Study site

    Detroit, Michigan

  • Study site

    Dothan, Alabama

  • Study site

    Jacksonville, Florida

  • Study site

    Little Rock, Arkansas

  • Study site

    Loxahatchee Groves, Florida

  • Study site

    Monaca, Pennsylvania

  • Study site

    New Brunswick, New Jersey

  • Study site

    Northport, Alabama

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Shreveport, Louisiana

  • Study site

    Suwanee, Georgia

  • Study site

    Toledo, Ohio

  • Study site

    Tulsa, Oklahoma

  • Study site

    Winfield, Illinois

  • Study site

    Witchita, Kansas

Other trials in United States

Poland8 sites

  • Study site

    Bialystok

  • Study site

    Gdansk

  • Study site

    Katowice

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Poznan

  • Study site

    Szczecin

  • Study site

    Warsaw

Other trials in Poland

Mexico7 sites

  • Study site

    Aguascalientes

  • Study site

    Distrio Federal

  • Study site

    Guadalajara

  • Study site

    Guadalajara Jalisco

  • Study site

    Mexico City

  • Study site

    Monterrey, Nuevo León

  • Study site

    Monterrey

Other trials in Mexico

Russia6 sites

  • Study site

    Kalingrad

  • Study site

    Kazan'

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Yaroslavl

Other trials in Russia

About this study

Official title: A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Conditions
Epilepsy
Being tested
Keppra XR
Keywords
Keppra XR, conversion to monotherapy, partial seizures
Medical subject headings
Epilepsy, Seizures

What participants receive

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

  • Keppra XRDrug

    Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks

  • Keppra XRDrug

    Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks

Study groups in NCT00419094
Study groupRoleWhat they receive
Keppra XR 1000 mg/dayExperimental1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)
Receives: Drug: Keppra XR
Keppra XR 2000 mg/dayExperimental2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)
Receives: Drug: Keppra XR

What is being measured

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

  1. The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase

    Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.

    Measured: 112 days

Secondary outcomes (3)

  1. The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase

    The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.

    Measured: 112 days

  2. The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase

    The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.

    Measured: 112 days

  3. The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase

    Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.

    Measured: 112 days

Timeline

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

  1. First posted8 Jan 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionSep 2009
  4. Study completionSep 2009

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, Investigator
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00419094
Sponsor's protocol ID
N01280
Other IDs
2007-000897-21
Status last verified
Jan 2011
First submitted
4 Jan 2007
Last updated
5 Sep 2014
Data monitoring committee
No

Publications

  • Chung S, Ceja H, Gawlowicz J, Avakyan G, McShea C, Schiemann J, Lu S. Levetiracetam extended release conversion to monotherapy for the treatment of patients with partial-onset seizures: a double-blind, randomised, multicentre, historical control study. Epilepsy Res. 2012 Aug;101(1-2):92-102. doi: 10.1016/j.eplepsyres.2012.03.007. Epub 2012 Apr 18.

    PubMed 22516508

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Keppra XR in people with Epilepsy, run by UCB Pharma at 45 sites in 4 countries.

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 3 inclusion and 4 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Poland, Mexico, Russia. 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. 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?

Yes. Results are posted in the registry (first posted 20 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase (time frame: 112 days). 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 NCT00419094, 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 5 Sep 2014.

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