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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/NCT01142193




Registration number
NCT01142193
Ethics application status
Date submitted
9/06/2010
Date registered
11/06/2010
Date last updated
22/05/2014

Titles & IDs
Public title
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Scientific title
A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures
Secondary ID [1] 0 0
2009-016996-31
Secondary ID [2] 0 0
P09-004
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
Treatment: Drugs - Placebo

Experimental: USL255 -

Placebo Comparator: Placebo -


Treatment: Drugs: USL255


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

Outcomes
Primary outcome [1] 0 0
Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
Timepoint [1] 0 0
11 weeks
Secondary outcome [1] 0 0
Proportion of Subjects With =50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
Timepoint [1] 0 0
11 weeks
Secondary outcome [2] 0 0
Proportion of Subjects With =50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
Timepoint [2] 0 0
3 weeks (weeks 1-3)
Secondary outcome [3] 0 0
Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
Timepoint [3] 0 0
3 weeks (weeks 1-3)
Secondary outcome [4] 0 0
Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.
Timepoint [4] 0 0
11 weeks
Secondary outcome [5] 0 0
Proportion of Subjects With =25%, =75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.
Timepoint [5] 0 0
3 weeks (weeks 1-3)
Secondary outcome [6] 0 0
Proportion of Subjects With =25%, =75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
Timepoint [6] 0 0
11 weeks
Secondary outcome [7] 0 0
Proportion of Subjects With =25%, =75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.
Timepoint [7] 0 0
8 weeks (weeks 4-11)
Secondary outcome [8] 0 0
Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.
Timepoint [8] 0 0
8 weeks (weeks 4-11)
Secondary outcome [9] 0 0
Proportion of Subjects =50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.
Timepoint [9] 0 0
8 weeks (weeks 4-11)

Eligibility
Key inclusion criteria
- Subject has a confirmed diagnosis of partial-onset seizures with or without secondary
generalization for at least 12 months prior to Visit 1.

- Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to
Visit 1 (12 weeks for phenobarbital and primidone).

- Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure
free days, during the 8-week baseline.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have a history of seizure episodes lasting less than 30 minutes in which several
seizures occur with such frequency that the initiation and completion of each
individual seizure cannot be distinguished, within 3 months prior to Visit 1.

- Have a history of pseudoseizures, or status epilepticus, within 3 months prior to
Visit 1.

- Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow
angle glaucoma.

- Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric
illness within 2 years of Visit 1.

- Currently taking, or have taken felbamate within the past 18 months, or have taken
vigabatrin in the past.

- Have taken topiramate within the past 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
249
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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Idaho
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Kentucky
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Maryland
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Missouri
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North Carolina
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Wisconsin
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Argentina
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Buenos Aires
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Cordoba
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Salta
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Brugge
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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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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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Munchen
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Athens
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Thessaloniki
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Hungary
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Budapest
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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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New Delhi
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Israel
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Ashkelon
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Haifa
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Holon
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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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Krakow
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Lodz
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Lublin
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Kazan
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Moscow
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Samara
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Tyumen
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Yaroslavi
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Cape Town
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Badalona
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Baracaldo
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Granada
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Spain
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Madrid

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 and effectiveness of USL255 as adjunctive
therapy in patients with refractory partial onset-seizures.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01142193
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
Name 0 0
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01142193