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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Experimental: USL255 -

Placebo comparator: Placebo -

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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Florida
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Idaho
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Kentucky
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Maryland
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Missouri
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New Jersey
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New York
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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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Cordoba
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Guaymallen
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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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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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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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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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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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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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Tyumen
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Baracaldo
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Granada
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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
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01142193