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CompletedNCT00522275Updated Jul 18, 2018Results posted

Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

A Phase 3 interventional study of lacosamide in Partial Epilepsies, sponsored by UCB BIOSCIENCES, Inc.. Completed at 60 sites in United States. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by UCB BIOSCIENCES, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
308
Allocation
Not applicable
Ages
16 Years to 70 Years
Sex
All
01

Study summary

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy

02

Conditions studied

  • Partial Epilepsies

Keywords

  • Adjunctive treatment in epilepsy
  • add-on treatment for epilepsy
  • partial seizures
  • AEDs
  • antiepileptic drugs
  • seizures
03

In context

Epilepsy

1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 308 is above the median of 50 across 1,205 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB BIOSCIENCES, Inc. is the lead sponsor of 28 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

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

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Completion of parent clinical trial for treatment of partial seizures

Exclusion criteria

Exclusion Criteria:

  • Receiving any study drug or experimental device other than lacosamide
  • Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
308 participants (actual)

Study arms

  • Experimental
    Lacosamide

    Up to 800 mg/day lacosamide (flexible dosing)

    Drug: lacosamide

Interventions

  • Druglacosamide

    50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

06

What researchers measure

Primary outcomes

  1. Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)

    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

    Time frame: During the Treatment Period (Maximum 6 years)

  2. Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)

    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

    Time frame: During the Treatment Period (Maximum 6 years)

  3. Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)

    Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

    Time frame: During the Treatment Period (Maximum 6 years)

Secondary outcomes

  1. Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)

    Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.

    Time frame: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)

  2. Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)

    At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.

    Time frame: Treatment Period (Maximum 6 years)

07

Results

Posted Nov 22, 2010

Participant flow

Participant flow — Overall Study
MilestoneLacosamide
Started308
Completed138
Not completed170
Withdrew: Adverse event35
Withdrew: Lack of efficacy80
Withdrew: Subject withdrew consent16
Withdrew: Protocol deviation1
Withdrew: Unsatisfactory compliance11
Withdrew: Lost to follow-up8
Withdrew: Other: subject wants to become pregnant2
Withdrew: Other: subject is pregnant2
Withdrew: Other: subject relocated2
Withdrew: Other: subject arrested1
Withdrew: Other: site / clinic closed4
Withdrew: Other: travel to / from site difficulty3
Withdrew: Other: sponsor request2
Withdrew: Other: subject ran out of medication1
Withdrew: Other: subject had surgery for epilepsy2

Outcome measures

PrimaryNumber of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame:
During the Treatment Period (Maximum 6 years)
Reported as:
Number · subjects
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
subjectsLacosamide
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)288
PrimaryNumber of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame:
During the Treatment Period (Maximum 6 years)
Reported as:
Number · subjects
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
subjectsLacosamide
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)33
PrimaryNumber of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)

Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Time frame:
During the Treatment Period (Maximum 6 years)
Reported as:
Number · subjects
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
subjectsLacosamide
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)71
SecondaryMedian Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)

Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.

Time frame:
Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Reported as:
Median · percentage change
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
percentage changeLacosamide
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)-48.5 (-100.0 to 567.7)
SecondaryPercentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)

At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.

Time frame:
Treatment Period (Maximum 6 years)
Reported as:
Number · percentage of subjects
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
percentage of subjectsLacosamide
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)48.2

Adverse events

Collected over Maximum of 6 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lacosamide—71/308 (23.1%)265/308 (86%)
Most frequent serious events
Showing 10 of 88
Most frequent serious events
EventLacosamide
ConvulsionNervous system disorders11/308
Chest painGeneral disorders5/308
PneumoniaInfections and infestations5/308
VomitingGastrointestinal disorders4/308
DizzinessNervous system disorders4/308
DehydrationMetabolism and nutrition disorders3/308
Status epilepticusNervous system disorders3/308
Mental status changesPsychiatric disorders3/308
Suicidal ideationPsychiatric disorders3/308
Atrial fibrillationCardiac disorders2/308
Most frequent other events
Showing 10 of 41
Most frequent other events
EventLacosamide
DizzinessNervous system disorders154/308
HeadacheNervous system disorders67/308
ContusionInjury, poisoning and procedural complications57/308
NauseaGastrointestinal disorders56/308
NasopharyngitisInfections and infestations53/308
VomitingGastrointestinal disorders47/308
FallInjury, poisoning and procedural complications47/308
DiplopiaEye disorders46/308
ConvulsionNervous system disorders44/308
TremorNervous system disorders41/308

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Lacosamide
<=18 years6
Between 18 and 65 years295
>=65 years7
Age, Continuous
Age, Continuous(years)Lacosamide
Mean38.2 ± 12.46
Sex: Female, Male
Sex: Female, Male(Participants)Lacosamide
Female146
Male162
Region of Enrollment
Region of Enrollment(participants)Lacosamide
United States308
08

Study locations

60 sites
  • Birmingham, Alabama, United States
  • Mobile, Alabama, United States
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Englewood, Colorado, United States
  • Fairfield, Connecticut, United States
  • Bradenton, Florida, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Saint Petersburg, Florida, United States
  • Tallahassee, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Springfield, Illinois, United States
  • Indianapolis, Indiana, United States
  • Wichita, Kansas, United States
  • Lexington, Kentucky, United States
  • Louisville, Kentucky, United States
  • Baltimore, Maryland, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • Golden Valley, Minnesota, United States
  • Saint Cloud, Minnesota, United States
  • Saint Paul, Minnesota, United States
  • Chesterfield, Missouri, United States
  • Somerset, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Syracuse, New York, United States
  • Asheville, North Carolina, United States
  • Durham, North Carolina, United States
  • Greenville, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Toledo, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Medford, Oregon, United States
  • Hershey, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Beaufort, South Carolina, United States
  • Charleston, South Carolina, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Charlottesville, Virginia, United States
  • Newport News, Virginia, United States
  • Norfolk, Virginia, United States
  • Richmond, Virginia, United States
  • Seattle, Washington, United States
  • Morgantown, West Virginia, United States
  • Marshfield, Wisconsin, United States
  • Milwaukee, Wisconsin, United States
09

References and documents

Publications

  • Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x. PubMed 22372628 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00522275
Lead sponsor
UCB BIOSCIENCES, Inc.
Responsible party
Sponsor
First posted
Aug 29, 2007
Start date
Oct 2004
Primary completion
Oct 2009
Completion
Oct 2009
Results posted
Nov 22, 2010
Last update
Jul 18, 2018

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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