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CompletedNCT00368069Updated Jul 15, 2020Results posted

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

A Phase 3 interventional study of Keppra® extended release formulation - XR and Placebo in Epilepsy, sponsored by UCB Pharma. Completed at 34 sites in 7 countries. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
12 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Epilepsy

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Keywords

  • Epilepsy
  • Keppra® XR
  • Levetiracetam XR
  • Extended release
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 158 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 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
12 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

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

Study arms

  • Experimental
    Keppra® XR

    Keppra® extended release formulation -XR

    Drug: Keppra® extended release formulation - XR

  • Placebo comparator
    Placebo

    placebo

    Drug: Placebo

Interventions

  • DrugKeppra® extended release formulation - XR

    500mg extended release oral tablet, 2 tablets once daily

    Also known as: Levetiracetam XR

  • DrugPlacebo

    oral tablets, 2 tablets once daily

06

What researchers measure

Primary outcomes

  1. Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population

    Number of POS over the treatment period standardized to 1 week period.

    Time frame: Treatment period (12 weeks)

  2. Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population

    Number of POS over the treatment period standardized to 1 week period

    Time frame: Treatment Period (12 weeks)

Secondary outcomes

  1. POS Seizure Frequency Per Week Over Baseline and Treatment Period

    Time frame: Baseline Period (8 weeks) - Treatment Period (12 weeks)

  2. 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)

    Time frame: Treatment period (12 weeks)

  3. 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.

    Time frame: Treatment period (12 weeks)

  4. 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.

    Time frame: over the treatment period (12 weeks)

07

Results

Posted Jul 28, 2009

Participant flow

The N01235 study began recruitment in August 2006 with study completion occurring in May 2007.

Participant flow — Overall Study
MilestoneKeppra®Placebo
Started7979
Completed7172
Not completed87
Withdrew: Adverse event52
Withdrew: Lack of efficacy01
Withdrew: Lost to follow-up10
Withdrew: Protocol violation02
Withdrew: Withdrawal of consent21
Withdrew: No blood sampling possible01

Outcome measures

PrimaryPartial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population

Number of POS over the treatment period standardized to 1 week period.

Time frame:
Treatment period (12 weeks)
Reported as:
Least squares mean · seizures per week (log-transformed data)
Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
seizures per week (log-transformed data)Keppra®Placebo
Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population0.912 ± 0.0531.067 ± 0.052
Statistical analysis
  • Keppra® vs Placebo · ANCOVA · p = 0.038 · Mean difference (net): 0.155 · 95% CI 0.009 to 0.301Analysis of covariance (ANCOVA) on (log-) POS freq/week over Treatment period with Treatment, (log-) Baseline POS freq/week as covariate.
  • Keppra® vs Placebo · Transf. of ANCOVA results on log data · Percent reduction over placebo: 14.4 · 95% CI 0.9 to 26.0Percent Reduction of Keppra over PBO is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))
SecondaryPOS Seizure Frequency Per Week Over Baseline and Treatment Period
Time frame:
Baseline Period (8 weeks) - Treatment Period (12 weeks)
Reported as:
Median · seizures per week
POS Seizure Frequency Per Week Over Baseline and Treatment Period
seizures per weekKeppra®Placebo
Baseline POS frequency per week1.80 (1.13 to 4.13)2.11 (1.33 to 3.26)
Treatment POS frequency per week0.99 (0.33 to 2.70)1.36 (0.92 to 2.85)
SecondaryAll (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)

Time frame:
Treatment period (12 weeks)
Reported as:
Least squares mean · seizures per week (log-transformed data)
All (Type I+II+III) Seizures Frequency Per Week
seizures per week (log-transformed data)Keppra®Placebo
All (Type I+II+III) Seizures Frequency Per Week0.928 ± 0.0531.086 ± 0.052
Statistical analysis
  • Keppra® vs Placebo · ANCOVA · p = 0.034 · Mean difference (net): 0.158 · 95% CI 0.012 to 0.305ANCOVA on (log-) seizure frequency per week over Treatment period with Treatment, (log-) Baseline seizure frequency per week as covariate.
  • Keppra® vs Placebo · Transf. of ANCOVA results on log data · Percent reduction over placebo: 14.7 · 95% CI 1.2 to 26.3Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))
Secondary50% 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.

Time frame:
Treatment period (12 weeks)
Reported as:
Number · Participants
50% Response in Weekly POS Frequency
ParticipantsKeppra®Placebo
Response3423
Non-Response4556
Statistical analysis
  • Keppra® vs Placebo · Regression, Logistic · p = 0.070 · Odds ratio (or): 1.84 · 95% CI 0.95 to 3.55Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the period (baseline or treatment period.
SecondaryResponse 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.

Time frame:
over the treatment period (12 weeks)
Reported as:
Number · Participants
Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks
ParticipantsKeppra®Placebo
< -25%1113
-25% - <25%1423
25% - <75%3534
75% - <100%117
100%82
Statistical analysis
  • Keppra® vs Placebo · Mantel Haenszel · p = 0.033Subjects with missing data during the Treatment period were considered in the category \<-25%.
PrimaryPartial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population

Number of POS over the treatment period standardized to 1 week period

Time frame:
Treatment Period (12 weeks)
Reported as:
Least squares mean · seizures per week (log-transformed data)
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
seizures per week (log-transformed data)Keppra®Placebo
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population0.914 ± 0.0491.119 ± 0.048
Statistical analysis
  • Keppra® vs Placebo · ANCOVA · p = 0.003 · Mean difference (net): 0.205 · 95% CI 0.070 to 0.341ANCOVA on (log-) Treatment POS frequency per week with Treatment and (log-) Baseline POS frequency per week as covariate
  • Keppra® vs Placebo · Transf. of ANCOVA results on log data · Percent reduction over placebo: 18.6 · 95% CI 6.7 to 28.9Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))

Adverse events

Collected over Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Keppra®—6/77 (7.8%)23/77 (29.9%)
Placebo—2/79 (2.5%)21/79 (26.6%)
Most frequent serious events
Most frequent serious events
EventKeppra®Placebo
ConcussionInjury, poisoning and procedural complications1/770/79
EpilepsyNervous system disorders1/771/79
Ischaemic strokeNervous system disorders1/770/79
Simple partial seizuresNervous system disorders1/770/79
Respiratory failureRespiratory, thoracic and mediastinal disorders1/770/79
RashSkin and subcutaneous tissue disorders1/770/79
Partial seizures with secondary generalisationNervous system disorders0/771/79
StuporNervous system disorders0/771/79
Most frequent other events
Most frequent other events
EventKeppra®Placebo
HeadacheNervous system disorders5/7711/79
InfluenzaInfections and infestations6/773/79
SomnolenceNervous system disorders6/772/79
IrritabilityGeneral disorders5/770/79
NasopharyngitisInfections and infestations5/774/79
NauseaGastrointestinal disorders4/772/79
DizzinessNervous system disorders4/772/79

Baseline characteristics

Age, Continuous
Age, Continuous(years)Keppra®PlaceboTotal
Mean33.97 ± 13.4132.38 ± 12.6033.17 ± 13.00
Sex: Female, Male
Sex: Female, Male(Participants)Keppra®PlaceboTotal
Female273259
Male524799
Region of Enrollment
Region of Enrollment(participants)Keppra®PlaceboTotal
Mexico151631.0
Finland224.0
Ukraine131225.0
South Africa448.0
Russian Federation191938.0
India252651.0
Brazil101.0
08

Study locations

34 sites
  • N01235 1007
    Curitiba, Brazil
  • N01235 2001
    Kuopio, Finland
  • N01235 2003
    Tampere, Finland
  • N01235 2002
    Turku, Finland
  • N01235 3008
    Chennai, India
  • N01235 3010
    Chennai, India
  • N01235 3012
    Ghandinagar, India
  • N01235 3003
    Hyderabad, India
  • N01235 3004
    Hyderabad, India
  • N01235 3001
    Lucknow, India
  • N01235 3009
    Madurai, India
  • N01235 3002
    Mumbai, India
  • N01235 3007
    Mumbai, India
  • N01235 3011
    Visakhapatnam, India
  • N01235 4006
    Aguascalientes, Mexico
  • N01235 4003
    Distrio Federal, Mexico
  • N01235 4001
    Guadalajara, Mexico
  • N01235 4005
    Puebla, Mexico
  • N01235 5001
    Moscow, Russian Federation
  • N01235 5002
    Moscow, Russian Federation
  • N01235 5003
    Moscow, Russian Federation
  • N01235 5005
    Moscow, Russian Federation
  • N01235 5006
    Moscow, Russian Federation
  • N01235 5007
    Moscow, Russian Federation
  • N01235 5004
    Saint Petersburg, Russian Federation
  • N01235 5009
    Saint Petersburg, Russian Federation
  • N01235 5008
    Smolensk, Russian Federation
  • N01235 6002
    Cape Town, South Africa
  • N01235 6003
    Umhlanga, South Africa
  • N01235 7001
    Kharkov, Ukraine
  • N01235 7004
    Kharkov, Ukraine
  • N01235 7005
    Lviv, Ukraine
  • N01235 7002
    Odessa, Ukraine
  • N01235 7003
    Poltava, Ukraine
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00368069
Lead sponsor
UCB Pharma
Responsible party
Sponsor
First posted
Aug 24, 2006
Start date
Aug 2006
Primary completion
May 2007
Completion
May 2007
Results posted
Jul 28, 2009
Last update
Jul 15, 2020

Study contacts

UCB Clinical Trial Call Center
study director · +1 877 822 9493 (UCB)

Oversight

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

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