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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
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
Secondary ID [1] 0 0
CR002233
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partial Seizure Disorder 0 0
Epilepsy 0 0
Seizures 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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
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
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline to endpoint of double blind phase

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
Minimum age
1 Month
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
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

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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Heidelberg West
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Subiaco
Recruitment postcode(s) [1] 0 0
- Heidelberg West
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Subiaco
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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India
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Bergen
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Chiangmai
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Donetsk
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Ukraine
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00113815
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.
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00113815