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CompletedNCT01191086Updated Feb 23, 2015Results posted

Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

A Phase 3 interventional study of USL255 in Epilepsy, sponsored by Upsher-Smith Laboratories. Completed at 68 sites in 15 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-02-23.

Sponsored by Upsher-Smith Laboratories · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
210
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

02

Conditions studied

  • Epilepsy

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Keywords

  • Epilepsy
  • partial onset seizure
  • adjunctive therapy
03

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's enrollment of 210 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Upsher-Smith Laboratories is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Have completed the maintenance period of the P09-004 study.
  • Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.
05

Study design

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

Study arms

  • Experimental
    Open-label USL255

    Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

    Drug: USL255

Interventions

  • DrugUSL255

    Also known as: Topiramate extended-release

06

What researchers measure

Primary outcomes

  1. Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations

    Time frame: Open label treatment of up to 62 weeks

07

Results

Posted Feb 23, 2015

Participant flow

Participant flow — Overall Study
MilestoneOpen-label USL255
Started210
Completed148
Not completed62
Withdrew: Adverse event20
Withdrew: Lack of efficacy10
Withdrew: Lost to follow-up4
Withdrew: Physician decision2
Withdrew: Withdrawal by subject24
Withdrew: Discontinuation criterion met1
Withdrew: Other1

Outcome measures

PrimaryEvaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Time frame:
Open label treatment of up to 62 weeks
Reported as:
Number · participants
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
participantsOpen-label USL255
No. of participants analyzed210
No. with ≥ 1 treatment-emergent AE146
No. with ≥ 1 treatment-related AE102
No. with severe AEs15
No. with serious AEs14
No. with TEAEs leading to study discontinuation20
No. of deaths related to study drug0
No. of deaths unrelated to study drug1

Adverse events

Collected over Open-label treatment of up to 62 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Open-label USL255—14/210 (6.7%)61/210 (29%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventOpen-label USL255
CholelithiasisHepatobiliary disorders2/210
Status epilepticusNervous system disorders2/210
Cholecystitis acuteHepatobiliary disorders1/210
ConvulsionNervous system disorders1/210
HeadacheNervous system disorders1/210
Ischaemic strokeNervous system disorders1/210
Acute psychosisPsychiatric disorders1/210
AppendicitisInfections and infestations1/210
Diarrhea infectiousInfections and infestations1/210
Lobar pneumoniaInfections and infestations1/210
Most frequent other events
Most frequent other events
EventOpen-label USL255
Weight decreasedInvestigations16/210
HeadacheNervous system disorders16/210
SomnolenceNervous system disorders15/210
DizzinessNervous system disorders13/210
AphasiaNervous system disorders11/210

Baseline characteristics

Age, Continuous
Age, Continuous(years)Open-label USL255
Mean37.5 ± 11.09
Sex: Female, Male
Sex: Female, Male(Participants)Open-label USL255
Female114
Male96
08

Study locations

68 sites
  • Phoenix, Arizona, United States
  • Ventura, California, United States
  • Gainsville, Florida, United States
  • Gulf Breeze, Florida, United States
  • Jacksonville, Florida, United States
  • Port Charlotte, Florida, United States
  • Lexington, Kentucky, United States
  • Waldorf, Maryland, United States
  • Chesterfield, Missouri, United States
  • St Louis, Missouri, United States
  • Somerset, New Jersey, United States
  • Charlotte, North Carolina, United States
  • Toledo, Ohio, United States
  • Dallas, Texas, United States
  • Temple, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Buenos Aires, Argentina
  • Cordoba, Argentina
  • Guaymallen, Argentina
  • Salta, Argentina
  • Bedford Park, Australia
  • Clayton, Australia
  • Fitzory, Australia
  • Heidelberg West, Australia
  • Parkville, Australia
  • Randwick, Australia
  • Woodville, Australia
  • Brugge, Belgium
  • Duffel, Belgium
  • Leuven, Belgium
  • Greenfield Park, Canada
  • Toronto, Canada
  • Santiago, Chile
  • Valdivia, Chile
  • Bonn, Germany
  • Munich, Germany
  • Athens, Greece
  • Thessaloniki, Greece
  • Bangalore, India
  • Dehradun, India
  • Hyderabad, India
  • Mangalore, India
  • Mumbai, India
  • New Delhi, India
  • Ashkelon, Israel
  • Holon, Israel
  • Nahariya, Israel
  • Petach Tikva, Israel
  • Ramat Gan, Israel
  • Auckland, New Zealand
  • Gdansk, Poland
  • Katowice, Poland
  • Krakow, Poland
  • Lodz, Poland
  • Lublin, Poland
  • Warszawa, Poland
  • Kazan, Russian Federation
  • Moscow, Russian Federation
  • Samara, Russian Federation
  • St Petersburg, Russian Federation
  • Tyumen, Russian Federation
  • Yaroslavi, Russian Federation
  • Cape Town, South Africa
  • Badalona, Spain
  • Baracaldo, Spain
  • Granada, Spain
  • Madrid, Spain
  • Valencia, Spain
09

References and documents

Publications

  • Chung SS, Hogan RE, Blatt I, Lawson P B, Nguyen H, Clark AM, Anders B, Halvorsen MB; PREVAIL OLE Study Group. Long-term safety and sustained efficacy of USL255 (topiramate extended-release capsules) in patients with refractory partial-onset seizures. Epilepsy Behav. 2016 Jun;59:13-20. doi: 10.1016/j.yebeh.2016.03.005. Epub 2016 Apr 14. PubMed 27084978 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2015, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2010
First posted
Aug 30, 2010
Start
Oct 2010
Primary completionActual
May 2014
CompletionActual
May 2014
Results first posted
Feb 23, 2015
Last update
Feb 23, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01191086
Lead sponsor
Upsher-Smith Laboratories
Responsible party
Sponsor
First posted
Aug 30, 2010
Start date
Oct 2010
Primary completion
May 2014
Completion
May 2014
Results posted
Feb 23, 2015
Last update
Feb 23, 2015
View the source record on ClinicalTrials.gov ↗

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