EpilepsyPhase 3NCT00368069

A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR

A Phase 3 study testing Keppra® extended release formulation - XR in people with Epilepsy, run by UCB Pharma at 34 sites in 7 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

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy. Read more about this study

Who is it for?: Ages 12 to 70 years
Conditions the study is for: Epilepsy
What is being tested?: Keppra® extended release formulation - XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 158 participants
Where: 34 sitesin 7 countries
Study dates: Aug 2006to May 2007
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 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients with a confirmed diagnosis of refractory epilepsy
Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Who cannot join

Seizures occurring in clusters
Status epilepticus within 3 months of Visit 1
History of non-epileptic seizures
Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control

Trial locations and contacts

34 sites in 7 countries.

Country

City, postcode or hospital

34 sites in 7 countries

India10 sites

N01235 3008
Chennai
N01235 3010
Chennai
N01235 3012
Gandhinagar
N01235 3003
Hyderabad
N01235 3004
Hyderabad
N01235 3001
Lucknow
N01235 3009
Madurai
N01235 3002
Mumbai
N01235 3007
Mumbai
N01235 3011
Visakhapatnam

Other trials in India

Russia9 sites

N01235 5001
Moscow
N01235 5002
Moscow
N01235 5003
Moscow
N01235 5005
Moscow
N01235 5006
Moscow
N01235 5007
Moscow
N01235 5004
Saint Petersburg
N01235 5009
Saint Petersburg
N01235 5008
Smolensk

Other trials in Russia

Ukraine5 sites

N01235 7001
Kharkiv
N01235 7004
Kharkiv
N01235 7005
Lviv
N01235 7002
Odesa
N01235 7003
Poltava

Other trials in Ukraine

Mexico4 sites

N01235 4006
Aguascalientes
N01235 4003
Distrio Federal
N01235 4001
Guadalajara
N01235 4005
Puebla City

Other trials in Mexico

Finland3 sites

N01235 2001
Kuopio
N01235 2003
Tampere
N01235 2002
Turku

Other trials in Finland

South Africa2 sites

N01235 6002
Cape Town
N01235 6003
Umhlanga

Other trials in South Africa

Brazil1 site

N01235 1007
Curitiba

Other trials in Brazil

About this study

Official title: A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Conditions: Epilepsy
Being tested: Keppra® extended release formulation - XR, Placebo
Keywords: Epilepsy, Keppra® XR, Levetiracetam XR, Extended release
Medical subject headings: Epilepsy

What participants receive

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

Keppra® extended release formulation - XRDrug
Also called Levetiracetam XR
500mg extended release oral tablet, 2 tablets once daily
PlaceboDrug
oral tablets, 2 tablets once daily

Study groups in NCT00368069
Study group	Role	What they receive
Keppra® XR	Experimental	Keppra® extended release formulation -XR Receives: Drug: Keppra® extended release formulation - XR
Placebo	Placebo comparator	placebo Receives: Drug: Placebo

What is being measured

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

Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
Number of POS over the treatment period standardized to 1 week period.
Measured: Treatment period (12 weeks)
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
Number of POS over the treatment period standardized to 1 week period
Measured: Treatment Period (12 weeks)

Secondary outcomes (4)

POS Seizure Frequency Per Week Over Baseline and Treatment Period
Measured: Baseline Period (8 weeks) - Treatment Period (12 weeks)
All (Type I+II+III) Seizures Frequency Per Week
Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)
Measured: Treatment period (12 weeks)
50% Response in Weekly POS Frequency
A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period.
Measured: Treatment period (12 weeks)
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.
Measured: over the treatment period (12 weeks)

Timeline

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

Aug 2006May 2007

First posted24 Aug 2006 (estimated)
Study startAug 2006
Primary completionMay 2007
Study completionMay 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00368069
Sponsor's protocol ID: N01235
Other IDs: 2006-000987-10
Status last verified: Jun 2020
First submitted: 11 Aug 2006
Last updated: 15 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x.
PubMed 19317886
Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20.
PubMed 19699156

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.
ClinicalTrials.gov ID: NCT00368069
Acronym / sponsor ID: N01235
Conditions: Epilepsy
Keywords: Epilepsy, Keppra® XR, Levetiracetam XR, Extended release
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 24 Aug 2006 (estimated)
Results: Posted 28 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Keppra® XR	Experimental	Drug: Keppra® extended release formulation - XRKeppra® extended release formulation -XR
Placebo	Placebo comparator	Drug: Placeboplacebo

Who may qualify

Ages: 12 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patients with a confirmed diagnosis of refractory epilepsy
Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Key exclusion criteria (5 listed)

Seizures occurring in clusters
Status epilepticus within 3 months of Visit 1
History of non-epileptic seizures
Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Keppra® extended release formulation - XRAlso: Levetiracetam XR500mg extended release oral tablet, 2 tablets once daily	Drug	Keppra® XR
Placebooral tablets, 2 tablets once daily	Drug	Placebo

Primary outcome

Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
Time frame: Treatment period (12 weeks)
Number of POS over the treatment period standardized to 1 week period.
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
Time frame: Treatment Period (12 weeks)
Number of POS over the treatment period standardized to 1 week period

4 secondary outcomes

POS Seizure Frequency Per Week Over Baseline and Treatment Period
Time frame: Baseline Period (8 weeks) - Treatment Period (12 weeks)
All (Type I+II+III) Seizures Frequency Per Week
Time frame: Treatment period (12 weeks)
50% Response in Weekly POS Frequency
Time frame: Treatment period (12 weeks)
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
Time frame: over the treatment period (12 weeks)

Results and safety

Results posted to the registry on 28 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Keppra®	79	71
Placebo	79	72

Primary outcome: Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population

Time frame: Treatment period (12 weeks). Least squares mean (Standard Error). Unit: seizures per week (log-transformed data)

Measure	Keppra® n = 75	Placebo n = 78
Value	0.912 (0.053)	1.067 (0.052)

Keppra® vs Placebo: Mean Difference (Net): 0.155 (95% CI 0.009 to 0.301), p = 0.038, ANCOVA
Keppra® vs Placebo: Percent reduction over Placebo: 14.4 (95% CI 0.9 to 26.0), Transf. of ANCOVA results on log data

Population analysed: Intention-to-treat (ITT) (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)

Primary outcome: Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population

Time frame: Treatment Period (12 weeks). Least squares mean (Standard Error). Unit: seizures per week (log-transformed data)

Measure	Keppra® n = 67	Placebo n = 69
Value	0.914 (0.049)	1.119 (0.048)

Keppra® vs Placebo: Mean Difference (Net): 0.205 (95% CI 0.070 to 0.341), p = 0.003, ANCOVA
Keppra® vs Placebo: Percent reduction over Placebo: 18.6 (95% CI 6.7 to 28.9), Transf. of ANCOVA results on log data

Population analysed: Per Protocol (PP) Population (Analyses were performed on subjects from the PP Population with non-missing information during both baseline and treatment period)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Keppra®	6 of 77 (7.8%)	23 of 77 (29.9%)	Not reported
Placebo	2 of 79 (2.5%)	21 of 79 (26.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19317886Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x.
Results publication: PubMed 19699156Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Epilepsy

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Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

34 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Keppra® extended release formulation - XR in people with Epilepsy, run by UCB Pharma at 34 sites in 7 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 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 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in India, Russia, Ukraine, Mexico, Finland and 2 more countries. 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?

Yes. Results are posted in the registry (first posted 28 Jul 2009). 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?

Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population (time frame: Treatment period (12 weeks)). The study lists 2 primary outcomes in all. 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 NCT00368069, which also lists 2 linked publications.

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 15 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.