EpilepsyPhase 3NCT01191086

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

A Phase 3 study testing USL255 in people with Epilepsy, run by Upsher-Smith Laboratories at 68 sites in 15 countries.

Completed

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

Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Epilepsy
What is being tested?: USL255
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 68 sitesin 15 countries
Study dates: Oct 2010to May 2014
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

68 sites in 15 countries.

Country

City, postcode or hospital

68 sites in 15 countries

United States16 sites

Study site
Charlotte, North Carolina
Study site
Chesterfield, Missouri
Study site
Dallas, Texas
Study site
Gainsville, Florida
Study site
Gulf Breeze, Florida
Study site
Jacksonville, Florida
Study site
Lexington, Kentucky
Study site
Milwaukee, Wisconsin
Study site
Phoenix, Arizona
Study site
Port Charlotte, Florida
Study site
Somerset, New Jersey
Study site
St Louis, Missouri
Study site
Temple, Texas
Study site
Toledo, Ohio
Study site
Ventura, California
Study site
Waldorf, Maryland

Other trials in United States

Australia7 sites

Study site
Bedford Park
Study site
Clayton
Study site
Fitzory
Study site
Heidelberg West
Study site
Parkville
Study site
Randwick
Study site
Woodville

Other trials in Australia

India6 sites

Study site
Bangalore
Study site
Dehradun
Study site
Hyderabad
Study site
Mangalore
Study site
Mumbai
Study site
New Delhi

Other trials in India

Poland6 sites

Study site
Gdansk
Study site
Katowice
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Warsaw

Other trials in Poland

Russia6 sites

Study site
Kazan'
Study site
Moscow
Study site
Saint Petersburg
Study site
Samara
Study site
Tyumen
Study site
Yaroslavi

Other trials in Russia

Israel5 sites

Study site
Ashkelon
Study site
Holon
Study site
Nahariya
Study site
Petah Tikva
Study site
Ramat Gan

Other trials in Israel

Spain5 sites

Study site
Badalona
Study site
Barakaldo
Study site
Granada
Study site
Madrid
Study site
Valencia

Other trials in Spain

Argentina4 sites

Study site
Buenos Aires
Study site
Córdoba
Study site
Salta
Study site
Villa Nueva

Other trials in Argentina

Belgium3 sites

Study site
Bruges
Study site
Duffel
Study site
Leuven

Other trials in Belgium

Canada2 sites

Study site
Greenfield Park
Study site
Toronto

Other trials in Canada

Chile2 sites

Study site
Santiago
Study site
Valdivia

Other trials in Chile

Germany2 sites

Study site
Bonn
Study site
Munich

Other trials in Germany

Greece2 sites

Study site
Athens
Study site
Thessaloniki

Other trials in Greece

New Zealand1 site

Study site
Auckland

Other trials in New Zealand

South Africa1 site

Study site
Cape Town

Other trials in South Africa

About this study

Official title: Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study

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

Conditions: Epilepsy
Being tested: USL255
Keywords: Epilepsy, partial onset seizure, adjunctive therapy
Medical subject headings: Epilepsy

What participants receive

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

USL255Drug
Also called Topiramate extended-release

Study groups in NCT01191086
Study group	Role	What they receive
Open-label USL255	Experimental	Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day Receives: Drug: USL255

What is being measured

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

Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Measured: Open label treatment of up to 62 weeks

Timeline

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

Oct 2010May 2014

First posted30 Aug 2010 (estimated)
Study startOct 2010
Primary completionMay 2014
Study completionMay 2014

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 (1)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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01191086
Sponsor's protocol ID: P09-005
Status last verified: Feb 2015
First submitted: 26 Aug 2010
Last updated: 23 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

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

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

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study
ClinicalTrials.gov ID: NCT01191086
Acronym / sponsor ID: P09-005
Conditions: Epilepsy
Keywords: Epilepsy, partial onset seizure, adjunctive therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: Upsher-Smith LaboratoriesIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 30 Aug 2010 (estimated)
Results: Posted 23 Feb 2015

Clinical summary

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

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open-label USL255	Experimental	Drug: USL255Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (0 listed)

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
USL255Also: Topiramate extended-release	Drug	Open-label USL255

Primary outcome

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

Results and safety

Results posted to the registry on 23 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-label USL255	210	148

Primary outcome: 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. Number. Unit: participants

Measure	Open-label USL255 n = 210
No. of participants analyzed	210
No. with ≥ 1 treatment-emergent AE	146
No. with ≥ 1 treatment-related AE	102
No. with severe AEs	15
No. with serious AEs	14
No. with TEAEs leading to study discontinuation	20
No. of deaths related to study drug	0
No. of deaths unrelated to study drug	1

Population analysed: The intent-to-treat (ITT) population was used for all analyses. The ITT population included all subjects who received at least 1 dose of study drug in this extension study.

Adverse events

Time frame: Open-label treatment of up to 62 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-label USL255	14 of 210 (6.7%)	61 of 210 (29%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27084978Chung 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.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

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.

The record lists no contact. Use the official record to reach the sponsor.

68 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing USL255 in people with Epilepsy, run by Upsher-Smith Laboratories at 68 sites in 15 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 2 inclusion and 0 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Australia, India, Poland, Russia and 10 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. 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 23 Feb 2015). 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?

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). 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 NCT01191086, 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 23 Feb 2015.