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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01191086




Registration number
NCT01191086
Ethics application status
Date submitted
26/08/2010
Date registered
30/08/2010
Date last updated
23/02/2015

Titles & IDs
Public title
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Scientific 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
Secondary ID [1] 0 0
P09-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - USL255

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


Treatment: Drugs: USL255
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Timepoint [1] 0 0
Open label treatment of up to 62 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
210
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Fitzory
Recruitment hospital [4] 0 0
- Heidelberg West
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- Randwick
Recruitment hospital [7] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Fitzory
Recruitment postcode(s) [4] 0 0
- Heidelberg West
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
- Randwick
Recruitment postcode(s) [7] 0 0
- Woodville
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Kentucky
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Maryland
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United States of America
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Missouri
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United States of America
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New Jersey
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North Carolina
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Ohio
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Texas
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Guaymallen
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Argentina
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Salta
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Belgium
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Brugge
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Belgium
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Duffel
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Belgium
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Leuven
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Canada
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Greenfield Park
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Canada
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Toronto
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Chile
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Santiago
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Chile
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Valdivia
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Germany
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Bonn
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Germany
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Munich
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Greece
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Athens
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Greece
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Thessaloniki
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India
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Bangalore
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India
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Dehradun
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India
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Hyderabad
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India
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Mangalore
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India
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Mumbai
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India
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New Delhi
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Israel
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Ashkelon
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Israel
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Holon
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Israel
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Nahariya
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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New Zealand
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Auckland
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Poland
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Gdansk
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Poland
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Katowice
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Krakow
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Lodz
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Lublin
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Warszawa
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Samara
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Russian Federation
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St Petersburg
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Russian Federation
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Tyumen
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Russian Federation
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Yaroslavi
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South Africa
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Cape Town
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Spain
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Badalona
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Spain
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Baracaldo
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Spain
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Granada
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Spain
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Madrid
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Spain
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Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Upsher-Smith Laboratories
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in
patients with refractory partial onset-seizures.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01191086
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Phone 0 0
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Email 0 0
Contact person for scientific queries