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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00113815
Registration number
NCT00113815
Ethics application status
Date submitted
10/06/2005
Date registered
13/06/2005
Date last updated
26/03/2014
Titles & IDs
Public title
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures
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Secondary ID [1]
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CR002233
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Partial Seizure Disorder
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Epilepsy
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Seizures
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - topiramate
Treatment: Drugs - topiramate
Treatment: Drugs - topiramate
Treatment: Drugs - placebo
Experimental: 003 - topiramate 25 mg/kg/day
Experimental: 002 - topiramate 15 mg/kg/day
Experimental: 001 - topiramate 5 mg/kg/day
Experimental: 004 - placebo placebo
Treatment: Drugs: topiramate
15 mg/kg/day
Treatment: Drugs: topiramate
5 mg/kg/day
Treatment: Drugs: topiramate
25 mg/kg/day
Treatment: Drugs: placebo
placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
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Assessment method [1]
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Timepoint [1]
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Video-recorded EEG was primary efficacy measure. Baseline vEEG and the vEEG at Visit 4 (Days 19 to 20; end point DB treatment phase or early withdrawal) will be read by a blinded central reader
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Secondary outcome [1]
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Percent treatment responders >=50% reduction seizure rate. ·Percentage change in seizure rate recorded on subject take-home records. Percentage change in seizure rates for all seizure types recorded on VEEG.
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Assessment method [1]
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Timepoint [1]
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Baseline to endpoint of double blind phase
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Eligibility
Key inclusion criteria
* 1-24 months, inclusive
* Concurrent 1 or 2 antiepileptic drugs
* Receiving regular enteral feedings
* Weigh between 3.5 and 15 kg
* Clinical or EEG evidence of simple or complex POS
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Minimum age
1
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Maximum age
24
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Exclusively breast fed and cannot take medicine by mouth
* Surgically implanted and functioning vagus nerve stimulator
* Renal stones
* Medically uncontrolled illnesses or conditions
* Infantile seizures as a result of a correctable medical condition
* Progressive neurologic disorder
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
1/11/2007
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Sample size
Target
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Accrual to date
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Final
118
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Recruitment in Australia
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- Heidelberg West
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- Melbourne
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- Subiaco
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- Heidelberg West
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- Melbourne
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- Subiaco
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).
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Trial website
https://clinicaltrials.gov/study/NCT00113815
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Trial related presentations / publications
Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20. Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028. Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.
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Public notes
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Contacts
Principal investigator
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
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Address
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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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
Type
Citations or Other Details
Journal
Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, W...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00113815
Download to PDF